Diabetes MellitusFRIENDS-TextNCT02384265
Financial Incentives and Text Messaging to Improve African American Womens' Glycemic Control
A study testing IM/SMS + Incentive Condition in people with Diabetes Mellitus, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Diabetes is a major public health problem that is associated with substantial health disparities for African American women compared to African American men or white men and women. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- IM/SMS + Incentive Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2012to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible persons with diabetes (PWDs) will be identified either through the clinic diabetes registry, referrals from their providers, or direct recruitment by study staff during clinic hours. Eligible subjects are African American women seen at the clinic at least once in the prior 12 months, who have a record of at least one A1c reading in the past year (most recent A1c >8%), indicate that they plan to receive their diabetes care from the clinic over the next 18 months, and have a cell phone with an active plan, have two other individuals who they identify as friends or family members to enroll with them.
- Eligible support team members (STMs) will be identified by the PWD as being a friend or family member 18 years or older and have a cell phone with an active plan.
- To enroll in the study, there must be a triad (1 PWD and 2 STMs) that meet all study inclusion requirements. After the study begins, if one of the STMs drops out/withdrawals from the study, the team can continue to participate. However, if the PWD drops out/withdrawals from the study, the team will not be able to continue in the study and therefore, will be dropped from the study by the principal investigator.
Who cannot join
- The investigators will exclude PWDs who are pregnant at the time of enrollment or those who only had diabetes during pregnancy, children, prisoners, homeless persons, institutionalized adults, and adults with type 1 diabetes, hemophilia, AIDS, cancer, hemoglobinopathies, or severe mental illness.
- The investigators will exclude STMs who are younger than 18 years old or do not have a cell phone with an active plan.
Trial locations and contacts
1 site in 1 country.
United States1 site
Holman United Methodist Church
Los Angeles, California, 90018
About this study
Official title: Financial Incentives and SMS to Improve African American Womens' Glycemic Control: Friends & Relatives Improving the Effectiveness of Networks for Diabetes Support Through Text Messaging (FRIENDS Text)
Diabetes is a major public health problem that is associated with substantial health disparities for African American women compared to African American men or white men and women. This project will incorporate a) new technology whose use is high among African Americans (cell phone text message reminders), b) support from social networks, and c) strategies from the emerging field of behavioral economics to encourage and support self care behaviors that lead to improvements in diabetes control.
In Stage I of the study, the investigators conducted focus groups with women with diabetes and their family members and friends. The investigators used information from these groups to work with a team of community partners to develop recruitment protocols, prepare study documents (including flyers, Frequently Asked Questions sheets, and informed consent forms), and finalize participant surveys.
In the next phase of the study the investigators will evaluate ways that friends and family members can use direct support and text messages to improve control of blood sugar for African American women with type 2 diabetes. A team of three people--the Person With Diabetes (PWD) and 2 friends or family members, also known as the Support Team Members (STMs)--will be assigned at random to one of two groups to compare approaches to improving control of blood sugar. Each team will receive information and resources on improving diabetes control and will be linked by a text messaging program. The intervention team will receive additional text messaging support that may help them improve the PWD's diabetes control.
Read the detailed description
Control Condition. Control group participants will consist of the person with diabetes (PWD) and their two support team members (STMs). The PWD will receive regular medical care from their usual providers. They will also receive an introductory educational session and written materials on diabetes, the importance of its control, and diabetes self-care strategies, and a blood glucose and physical activity monitoring log. They will be invited for study visits, distinct from their routine clinic visits, at 3, 6, and 12 months to measure cholesterol, A1c (for those with diabetes), blood pressure, height, and weight measurement. Participants in the control condition will receive generic health promotion information during in-person visits or by mail. They will receive follow-up messages by text to remind them about study related events.
Intervention Group. Participants in the intervention condition will consist of the PWD and their two STMs. The PWD will receive the same protocols that the "Usual Care" participants receive, including an introductory educational session, written materials on diabetes, a blood glucose log, and a physical activity monitoring log.
The PWDs in the intervention group will receive training in action planning that is linked to their role self-identity. Role identity will be kept highly salient throughout the study by using identity primes that remind the individual that both processes (diabetes self-care behaviors) and goals (achieving A1c targets) are important responsibilities associated with that role. For example, participants may be asked to keep a picture or memento that reminds them of their role identity (e.g., a picture of a child or a photo of a place she would like to visit) on a blood sugar and physical activity log that the study will provide to the patient. The STMs in the intervention group will discuss these role identities and motivators with the PWD in their team intake session. They will also obtain similar training in action planning and in ways to support the PWD in order to better control her diabetes.
Intervention team members will be reminded of the PWD's intrinsic motivations (IM), and how engaging in regular diabetes self-care can improve diabetes control, during interactions designed to boost the participants' confidence that they can accomplish and sustain the behavior change that contributes to interim and longer term goals. These interactions include text messages between the support team and the study team and between members of the support team. The text messages will include individually- and/or culturally-tailored messages, some of which are linked to the motivating factors identified through the questionnaire and probes. The text messages will take varying forms: (a) General diabetes messages derived from sources such as the ADA African American Programs and the National Diabetes Education Program; (b) Reminders about blood glucose monitoring, medication adherence, diet, and exercise, and how these behaviors contribute to maintaining role identity; (c) Prompts or queries about home glucose monitor readings and their frequencies that allow participants to communicate by text with study staff on non-urgent matters; and (d) Challenges and contests for which they receive supportive text messages.
Face-to-Face Meetings will occur at the baseline and months 3, 6, and 12 to gather study data. For the intervention group, this will also include contact with a study team member who helps the intervention PWD and STMs identify and agree to desired behaviors and A1c targets. The study team member will review glucometer readings, medication refills, and A1c levels; encourage each PWD to engage in processes (e.g., self-monitoring or adhering to medications); encourage STMs in their supportive roles; congratulate those PWDs who near or reach A1c targets; and motivate those having difficulty reaching their targets.
Baseline Protocols and Data Collection After randomization, all participants will be asked to provide verbal consent for the survey tailored to their study arm and their role as a PWD or STM, and will be administered a 35-45 minute baseline in-person survey in English by phone. There will be four different versions of the survey: Intervention PWD, Intervention STM, Control PWD, and Control STM. Following the administration of the baseline survey, all intervention participants will be allowed to select the message themes that they would like to receive from a list of options based on factors that they identified as intrinsic motivators and the intervals at which they would like to receive text messages (range 5 per week to 2 per day). The investigators plan to send an average of three messages per day, and elicit on average 1-2 responses per day. Additionally, the intervention PWDs will be told their target A1c goals and the incentives associated with specific drops in A1c. At this stage, the study staff will again discuss with the PWDs and STMs intervention groups the potential risks and harms of using inappropriate strategies to try to attain glycemic targets and, to obtain the monetary incentives. All enrolled patients will participate in a small group 30 minute session with study staff in the clinic to discuss diabetes self-care. All participants will also be invited to participate in ongoing diabetes classes and activities, and each person will be given a list of diabetes resources available in their clinic (e.g. group and individual diabetes education) and a calendar of local events and activities, such as the ADA Project Power diabetes classes in local churches, exercise classes, and healthy eating groups.
Follow-up Protocols and Data Collection Once a month for the 6 month intervention period, participants in the intervention groups will receive a phone call from study staff to reinforce intrinsic motivation for improved glycemic control. At months 3, 6, and 12, participants (PWDs) in the control and intervention group will receive a reminder that the A1c test is due (via phone, mail, and text message). At months 3 and 6, the intervention team will also receive a message (via phone, mail, and text) about the deadline for an in-person incentive payment. In addition, intervention participants (PWDs) who attain target A1c levels will receive the appropriate monetary incentives based on their new A1c levels and through participation in the lottery. Compensation and incentives will be delivered at the time of testing. At the 6 month visit, all study subjects in both groups will be administered an abbreviated version of the baseline survey. At this point the financial incentives will be withdrawn and the IM, reminder, and generic text messages will stop for the intervention arm, who, like the control arm, will only receive reminder messages for clinic visits to get A1c tested (A1c testing will only be completed with PWDs in the control and intervention groups). At 12 months, all PWD and STM participants will complete a final survey. In the event the investigators are unable to reach the study participants, the investigators will obtain alternate contact information during study enrollment for all participants using a locator form. This form will be stored separate from the study participants' data. This will help to increase retention over the course of the study, and the investigators will update contact information regularly via the text messages. Once the 12-month study visit has been completed, the locator form will be destroyed.
Assess the costs of the interventions In order to determine feasibility of importing the results of this study into public community clinics a costs analysis is planned at the end of the study. Costs fall into two main categories: program costs and costs of health services used by study participants. Program costs will be based on actual costs incurred by the study, including staff time and supplies, as well as the opportunity cost of time incurred by participants for attending quarterly study visits and participating in study phone calls. Costs related to personnel time will be measured as the product of personnel time spent and unit cost of labor and fringe benefits for the study staff. Personnel time spent for each study condition will be estimated from self-report. Costs related to use of resources (equipment and supplies, overhead) will be measured as the product of quantities used and unit cost derived from accounting data. The program developmental and training costs will be measured, but will be divided equally for the two intervention arms since identical protocols and provider trainings are required in each arm. Costs that are solely for research purpose, such as data management and analysis, will be excluded. The investigators will derive health services costs from survey data collected in the surveys from all study participants. These data include information on the number of outpatient medical visits, hospital stays, and Emergency Department visits. Using data in the published literature (e.g. using Medicare data), the investigators will map costs onto units of utilization, such as the cost for one physician office visit or one day in the hospital, thereby allowing the investigators to estimate total costs incurred for health services.
- Conditions
- Diabetes Mellitus
- Being tested
- IM/SMS + Incentive Condition
- Keywords
- Diabetes, Disparities, Behavioral, Text messaging, Social networks, African American, Female
- Medical subject headings
- Diabetes Mellitus, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM/SMS + Incentive ConditionBehavioural
See description of Intervention arm protocols above.
| Study group | Role | What they receive |
|---|---|---|
| IM/SMS + Incentive Condition | Experimental | Participants in the intervention condition will consist of the PWD and their two STMs. The PWD and STM will receive the same protocols that the "Usual Care" participants receive, including an introductory educational session, written materials on diabetes, a blood glucose log, and a physical activity monitoring log. The PWDs in this condition will also receive training in action planning with their STMs. They will also receive SMS messages supporting diabetes self-care from the study team. The study team will also encourage the STMs to interaction in person and via text messages with the PWD. Receives: Behavioral: IM/SMS + Incentive Condition |
| Control | No intervention | Control group participants will consist of the person with diabetes (PWD) and their two support team members (STM). The PWD will receive regular medical care from their usual providers. They will also receive an introductory educational session and written materials on diabetes, the importance of its control, and diabetes self-care strategies, and a blood glucose and physical activity monitoring log. They will be invited for study visits at 3, 6, and 12 months to measure cholesterol, A1c (for those with diabetes), blood pressure, height, and weight measurement. PWDs and STMs in the control condition will receive generic health promotion information during in-person visits or by mail. They will receive follow-up messages by text to remind them about study related events. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hemoglobin A1c at 12-months
The investigators will measure the change in hemoglobin A1c (measured as % A1c).
Measured: 12-months
Secondary outcomes (4)
Change from Baseline in Weight 12-months
The investigators will measure the change in weight (measured in kg).
Measured: 12 months
Change from Baseline in Body Mass Index at 12-months
The investigators will measure the change in Body Mass Index (measured in kg/meter2).
Measured: 12 months
Change from Baseline in Waist Circumference (inches) at 12-months
The investigators will measure the change in waist circumference (measured in centimeters).
Measured: 12 months
Change from Baseline in Systolic and Diastolic Blood Pressure at 12-months
The investigators will measure the change in systolic and diastolic blood pressure measured in mmHg.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study start21 Jun 2012
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (83)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arleen F. Brown, MD, PhD, University of California, Los Angeles
- Investigators
- Arleen F Brown, M.D., Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384265
- Sponsor's protocol ID
- 1P60MD006923
- Acronym
- FRIENDS-Text
- Status last verified
- Apr 2022
- First submitted
- 25 Feb 2015
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sacks DB, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, Parrott M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem. 2002 Mar;48(3):436-72.
PubMed 11861436Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
PubMed 10938048Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65.
PubMed 9742977Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N, Shichiri M. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995 May;28(2):103-17. doi: 10.1016/0168-8227(95)01064-k.
PubMed 7587918Grant R, Adams AS, Trinacty CM, Zhang F, Kleinman K, Soumerai SB, Meigs JB, Ross-Degnan D. Relationship between patient medication adherence and subsequent clinical inertia in type 2 diabetes glycemic management. Diabetes Care. 2007 Apr;30(4):807-12. doi: 10.2337/dc06-2170. Epub 2007 Jan 26.
PubMed 17259469Grant RW, Cagliero E, Dubey AK, Gildesgame C, Chueh HC, Barry MJ, Singer DE, Nathan DM, Meigs JB. Clinical inertia in the management of Type 2 diabetes metabolic risk factors. Diabet Med. 2004 Feb;21(2):150-5. doi: 10.1111/j.1464-5491.2004.01095.x.
PubMed 14984450Brown AF, Gregg EW, Stevens MR, Karter AJ, Weinberger M, Safford MM, Gary TL, Caputo DA, Waitzfelder B, Kim C, Beckles GL. Race, ethnicity, socioeconomic position, and quality of care for adults with diabetes enrolled in managed care: the Translating Research Into Action for Diabetes (TRIAD) study. Diabetes Care. 2005 Dec;28(12):2864-70. doi: 10.2337/diacare.28.12.2864.
PubMed 16306546Heisler M, Smith DM, Hayward RA, Krein SL, Kerr EA. Racial disparities in diabetes care processes, outcomes, and treatment intensity. Med Care. 2003 Nov;41(11):1221-32. doi: 10.1097/01.MLR.0000093421.64618.9C.
PubMed 14583685Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic control of adults with type 2 diabetes. Diabetes Care. 1999 Mar;22(3):403-8. doi: 10.2337/diacare.22.3.403.
PubMed 10097918Karter AJ, Ferrara A, Liu JY, Moffet HH, Ackerson LM, Selby JV. Ethnic disparities in diabetic complications in an insured population. JAMA. 2002 May 15;287(19):2519-27. doi: 10.1001/jama.287.19.2519.
PubMed 12020332Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.
PubMed 17881626Sequist TD, Fitzmaurice GM, Marshall R, Shaykevich S, Marston A, Safran DG, Ayanian JZ. Cultural competency training and performance reports to improve diabetes care for black patients: a cluster randomized, controlled trial. Ann Intern Med. 2010 Jan 5;152(1):40-6. doi: 10.7326/0003-4819-152-1-201001050-00009.
PubMed 20048271Lussier JP, Heil SH, Mongeon JA, Badger GJ, Higgins ST. A meta-analysis of voucher-based reinforcement therapy for substance use disorders. Addiction. 2006 Feb;101(2):192-203. doi: 10.1111/j.1360-0443.2006.01311.x.
PubMed 16445548Malotte CK, Rhodes F, Mais KE. Tuberculosis screening and compliance with return for skin test reading among active drug users. Am J Public Health. 1998 May;88(5):792-6. doi: 10.2105/ajph.88.5.792.
PubMed 9585747
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives and SMS to Improve African American Womens' Glycemic Control: Friends & Relatives Improving the Effectiveness of Networks for Diabetes Support Through Text Messaging (FRIENDS Text)
- ClinicalTrials.gov ID
- NCT02384265
- Acronym / sponsor ID
- FRIENDS-Text / 1P60MD006923
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Disparities, Behavioral, Text messaging, Social networks, African American, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 21 Jun 2012
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes is a major public health problem that is associated with substantial health disparities for African American women compared to African American men or white men and women. This project will incorporate a) new technology whose use is high among African Americans (cell phone text message reminders), b) support from social networks, and c) strategies from the emerging field of behavioral economics to encourage and support self care behaviors that lead to improvements in diabetes control.
In Stage I of the study, the investigators conducted focus groups with women with diabetes and their family members and friends. The investigators used information from these groups to work with a team of community partners to develop recruitment protocols, prepare study documents (including flyers, Frequently Asked Questions sheets, and informed consent forms), and finalize participant surveys.
In the next phase of the study the investigators will evaluate ways that friends and family members can use direct support and text messages to improve control of blood sugar for African American women with type 2 diabetes. A team of three people--the Person With Diabetes (PWD) and 2 friends or family members, also known as the Support Team Members (STMs)--will be assigned at random to one of two groups to compare approaches to improving control of blood sugar. Each team will receive information and resources on improving diabetes control and will be linked by a text messaging program. The intervention team will receive additional text messaging support that may help them improve the PWD's diabetes control.
Detailed description
Control Condition. Control group participants will consist of the person with diabetes (PWD) and their two support team members (STMs). The PWD will receive regular medical care from their usual providers. They will also receive an introductory educational session and written materials on diabetes, the importance of its control, and diabetes self-care strategies, and a blood glucose and physical activity monitoring log. They will be invited for study visits, distinct from their routine clinic visits, at 3, 6, and 12 months to measure cholesterol, A1c (for those with diabetes), blood pressure, height, and weight measurement. Participants in the control condition will receive generic health promotion information during in-person visits or by mail. They will receive follow-up messages by text to remind them about study related events.
Intervention Group. Participants in the intervention condition will consist of the PWD and their two STMs. The PWD will receive the same protocols that the "Usual Care" participants receive, including an introductory educational session, written materials on diabetes, a blood glucose log, and a physical activity monitoring log.
The PWDs in the intervention group will receive training in action planning that is linked to their role self-identity. Role identity will be kept highly salient throughout the study by using identity primes that remind the individual that both processes (diabetes self-care behaviors) and goals (achieving A1c targets) are important responsibilities associated with that role. For example, participants may be asked to keep a picture or memento that reminds them of their role identity (e.g., a picture of a child or a photo of a place she would like to visit) on a blood sugar and physical activity log that the study will provide to the patient. The STMs in the intervention group will discuss these role identities and motivators with the PWD in their team intake session. They will also obtain similar training in action planning and in ways to support the PWD in order to better control her diabetes.
Intervention team members will be reminded of the PWD's intrinsic motivations (IM), and how engaging in regular diabetes self-care can improve diabetes control, during interactions designed to boost the participants' confidence that they can accomplish and sustain the behavior change that contributes to interim and longer term goals. These interactions include text messages between the support team and the study team and between members of the support team. The text messages will include individually- and/or culturally-tailored messages, some of which are linked to the motivating factors identified through the questionnaire and probes. The text messages will take varying forms: (a) General diabetes messages derived from sources such as the ADA African American Programs and the National Diabetes Education Program; (b) Reminders about blood glucose monitoring, medication adherence, diet, and exercise, and how these behaviors contribute to maintaining role identity; (c) Prompts or queries about home glucose monitor readings and their frequencies that allow participants to communicate by text with study staff on non-urgent matters; and (d) Challenges and contests for which they receive supportive text messages.
Face-to-Face Meetings will occur at the baseline and months 3, 6, and 12 to gather study data. For the intervention group, this will also include contact with a study team member who helps the intervention PWD and STMs identify and agree to desired behaviors and A1c targets. The study team member will review glucometer readings, medication refills, and A1c levels; encourage each PWD to engage in processes (e.g., self-monitoring or adhering to medications); encourage STMs in their supportive roles; congratulate those PWDs who near or reach A1c targets; and motivate those having difficulty reaching their targets.
Baseline Protocols and Data Collection After randomization, all participants will be asked to provide verbal consent for the survey tailored to their study arm and their role as a PWD or STM, and will be administered a 35-45 minute baseline in-person survey in English by phone. There will be four different versions of the survey: Intervention PWD, Intervention STM, Control PWD, and Control STM. Following the administration of the baseline survey, all intervention participants will be allowed to select the message themes that they would like to receive from a list of options based on factors that they identified as intrinsic motivators and the intervals at which they would like to receive text messages (range 5 per week to 2 per day). The investigators plan to send an average of three messages per day, and elicit on average 1-2 responses per day. Additionally, the intervention PWDs will be told their target A1c goals and the incentives associated with specific drops in A1c. At this stage, the study staff will again discuss with the PWDs and STMs intervention groups the potential risks and harms of using inappropriate strategies to try to attain glycemic targets and, to obtain the monetary incentives. All enrolled patients will participate in a small group 30 minute session with study staff in the clinic to discuss diabetes self-care. All participants will also be invited to participate in ongoing diabetes classes and activities, and each person will be given a list of diabetes resources available in their clinic (e.g. group and individual diabetes education) and a calendar of local events and activities, such as the ADA Project Power diabetes classes in local churches, exercise classes, and healthy eating groups.
Follow-up Protocols and Data Collection Once a month for the 6 month intervention period, participants in the intervention groups will receive a phone call from study staff to reinforce intrinsic motivation for improved glycemic control. At months 3, 6, and 12, participants (PWDs) in the control and intervention group will receive a reminder that the A1c test is due (via phone, mail, and text message). At months 3 and 6, the intervention team will also receive a message (via phone, mail, and text) about the deadline for an in-person incentive payment. In addition, intervention participants (PWDs) who attain target A1c levels will receive the appropriate monetary incentives based on their new A1c levels and through participation in the lottery. Compensation and incentives will be delivered at the time of testing. At the 6 month visit, all study subjects in both groups will be administered an abbreviated version of the baseline survey. At this point the financial incentives will be withdrawn and the IM, reminder, and generic text messages will stop for the intervention arm, who, like the control arm, will only receive reminder messages for clinic visits to get A1c tested (A1c testing will only be completed with PWDs in the control and intervention groups). At 12 months, all PWD and STM participants will complete a final survey. In the event the investigators are unable to reach the study participants, the investigators will obtain alternate contact information during study enrollment for all participants using a locator form. This form will be stored separate from the study participants' data. This will help to increase retention over the course of the study, and the investigators will update contact information regularly via the text messages. Once the 12-month study visit has been completed, the locator form will be destroyed.
Assess the costs of the interventions In order to determine feasibility of importing the results of this study into public community clinics a costs analysis is planned at the end of the study. Costs fall into two main categories: program costs and costs of health services used by study participants. Program costs will be based on actual costs incurred by the study, including staff time and supplies, as well as the opportunity cost of time incurred by participants for attending quarterly study visits and participating in study phone calls. Costs related to personnel time will be measured as the product of personnel time spent and unit cost of labor and fringe benefits for the study staff. Personnel time spent for each study condition will be estimated from self-report. Costs related to use of resources (equipment and supplies, overhead) will be measured as the product of quantities used and unit cost derived from accounting data. The program developmental and training costs will be measured, but will be divided equally for the two intervention arms since identical protocols and provider trainings are required in each arm. Costs that are solely for research purpose, such as data management and analysis, will be excluded. The investigators will derive health services costs from survey data collected in the surveys from all study participants. These data include information on the number of outpatient medical visits, hospital stays, and Emergency Department visits. Using data in the published literature (e.g. using Medicare data), the investigators will map costs onto units of utilization, such as the cost for one physician office visit or one day in the hospital, thereby allowing the investigators to estimate total costs incurred for health services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IM/SMS + Incentive Condition | Experimental | Behavioral: IM/SMS + Incentive ConditionParticipants in the intervention condition will consist of the PWD and their two STMs. The PWD and STM will receive the same protocols that the "Usual Care" participants receive, including an introductory educational session, written materials on diabetes, a blood glucose log, and a physical activity monitoring log. The PWDs in this condition will also receive training in action planning with their STMs. They will also receive SMS messages supporting diabetes self-care from the study team. The study team will also encourage the STMs to interaction in person and via text messages with the PWD. |
| Control | No intervention | –Control group participants will consist of the person with diabetes (PWD) and their two support team members (STM). The PWD will receive regular medical care from their usual providers. They will also receive an introductory educational session and written materials on diabetes, the importance of its control, and diabetes self-care strategies, and a blood glucose and physical activity monitoring log. They will be invited for study visits at 3, 6, and 12 months to measure cholesterol, A1c (for those with diabetes), blood pressure, height, and weight measurement. PWDs and STMs in the control condition will receive generic health promotion information during in-person visits or by mail. They will receive follow-up messages by text to remind them about study related events. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible persons with diabetes (PWDs) will be identified either through the clinic diabetes registry, referrals from their providers, or direct recruitment by study staff during clinic hours. Eligible subjects are African American women seen at the clinic at least once in the prior 12 months, who have a record of at least one A1c reading in the past year (most recent A1c >8%), indicate that they plan to receive their diabetes care from the clinic over the next 18 months, and have a cell phone with an active plan, have two other individuals who they identify as friends or family members to enroll with them.
- Eligible support team members (STMs) will be identified by the PWD as being a friend or family member 18 years or older and have a cell phone with an active plan.
- To enroll in the study, there must be a triad (1 PWD and 2 STMs) that meet all study inclusion requirements. After the study begins, if one of the STMs drops out/withdrawals from the study, the team can continue to participate. However, if the PWD drops out/withdrawals from the study, the team will not be able to continue in the study and therefore, will be dropped from the study by the principal investigator.
Key exclusion criteria (2 listed)
- The investigators will exclude PWDs who are pregnant at the time of enrollment or those who only had diabetes during pregnancy, children, prisoners, homeless persons, institutionalized adults, and adults with type 1 diabetes, hemophilia, AIDS, cancer, hemoglobinopathies, or severe mental illness.
- The investigators will exclude STMs who are younger than 18 years old or do not have a cell phone with an active plan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IM/SMS + Incentive ConditionSee description of Intervention arm protocols above. | Behavioural | IM/SMS + Incentive Condition |
Primary outcome
Change from Baseline in Hemoglobin A1c at 12-months
Time frame: 12-months
The investigators will measure the change in hemoglobin A1c (measured as % A1c).
4 secondary outcomes
Change from Baseline in Weight 12-months
Time frame: 12 months
Change from Baseline in Body Mass Index at 12-months
Time frame: 12 months
Change from Baseline in Waist Circumference (inches) at 12-months
Time frame: 12 months
Change from Baseline in Systolic and Diastolic Blood Pressure at 12-months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Background: PubMed 11861436Sacks DB, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, Parrott M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem. 2002 Mar;48(3):436-72.
- Background: PubMed 10938048Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
- Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Background: PubMed 9742977Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65.
- Background: PubMed 7587918Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N, Shichiri M. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995 May;28(2):103-17. doi: 10.1016/0168-8227(95)01064-k.
- Background: PubMed 17259469Grant R, Adams AS, Trinacty CM, Zhang F, Kleinman K, Soumerai SB, Meigs JB, Ross-Degnan D. Relationship between patient medication adherence and subsequent clinical inertia in type 2 diabetes glycemic management. Diabetes Care. 2007 Apr;30(4):807-12. doi: 10.2337/dc06-2170. Epub 2007 Jan 26.
- Background: PubMed 14984450Grant RW, Cagliero E, Dubey AK, Gildesgame C, Chueh HC, Barry MJ, Singer DE, Nathan DM, Meigs JB. Clinical inertia in the management of Type 2 diabetes metabolic risk factors. Diabet Med. 2004 Feb;21(2):150-5. doi: 10.1111/j.1464-5491.2004.01095.x.
- Background: PubMed 16306546Brown AF, Gregg EW, Stevens MR, Karter AJ, Weinberger M, Safford MM, Gary TL, Caputo DA, Waitzfelder B, Kim C, Beckles GL. Race, ethnicity, socioeconomic position, and quality of care for adults with diabetes enrolled in managed care: the Translating Research Into Action for Diabetes (TRIAD) study. Diabetes Care. 2005 Dec;28(12):2864-70. doi: 10.2337/diacare.28.12.2864.
- Background: PubMed 14583685Heisler M, Smith DM, Hayward RA, Krein SL, Kerr EA. Racial disparities in diabetes care processes, outcomes, and treatment intensity. Med Care. 2003 Nov;41(11):1221-32. doi: 10.1097/01.MLR.0000093421.64618.9C.
- Background: PubMed 10097918Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic control of adults with type 2 diabetes. Diabetes Care. 1999 Mar;22(3):403-8. doi: 10.2337/diacare.22.3.403.
- Background: PubMed 12020332Karter AJ, Ferrara A, Liu JY, Moffet HH, Ackerson LM, Selby JV. Ethnic disparities in diabetic complications in an insured population. JAMA. 2002 May 15;287(19):2519-27. doi: 10.1001/jama.287.19.2519.
- Background: PubMed 17881626Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.
- Cellular Telecommunications and Internet Association. Semi-Annual Wireless Industry survey. Washington 2006.Link provided by the sponsor.
- Smith A. Mobile Access 2010. Pew Internet and American Life Project. 2010Link provided by the sponsor.
- Fox S. Mobile Health 2010. Pew Internet and American Life Project. 2010Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arleen F Brown, M.D., Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IM/SMS + Incentive Condition in people with Diabetes Mellitus, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Hemoglobin A1c at 12-months (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384265, which also lists 83 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.