DiabetesNCT00214474
Improving Diabetes Efforts Across Language and Literacy (IDEALL)
A study testing ATSM Intervention and GMV Intervention in people with Diabetes, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
Trial summary
The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm randomized controlled trial to explore contextual factors at the patient, clinician, and organizational level of two patient self-management support strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- ATSM Intervention and GMV Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Nov 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have type 2 diabetes
- have a HbA1c equal to or > 8.0%
- must speak English, Spanish, or Cantonese.
Who cannot join
- Dementia
- Psychosis/Schizophrenia
- End Stage Renal Disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Ucsf Dept of Medicine Box 1364
San Francisco, California, 94143-1364
About this study
The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm randomized controlled trial to explore contextual factors at the patient, clinician, and organizational level of two patient self-management support strategies. A communication technology-based intervention (automated telephone diabetes management) and an interpersonally-oriented intervention (group medical visits)will be compared to usual care for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net health centers in the University of California, San Francisco (UCSF) Collaborative Research Network.
Read the detailed description
See above
- Conditions
- Diabetes
- Being tested
- ATSM Intervention, GMV Intervention
- Keywords
- Disease Management, Health Literacy, Telephone Care, Group Medical Visits, Type 2 Diabetes, Access to Care, Technology, Language Barriers
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATSM InterventionBehavioural
Also called ATSM: Automated Telephone Self-Management Support
Participants randomized to ATSM Intervention received weekly, automated (pre-recorded) telephone calls over 39 weeks (9 months). Patient responses triggered either immediate, automated health education messages and/or subsequent nurse phone follow-up.
GMV InterventionBehavioural
Also called GMV: Group Medical Visits
GMV Intervention involved 90-minute monthly sessions over 9 months, involving 6-10 participants, co-facilitated by a primary care physician and health educator.
| Study group | Role | What they receive |
|---|---|---|
| ATSM Intervention | Active comparator | ATSM Intervention: Automated Telephone Self-Management Support Receives: Behavioral: ATSM Intervention |
| GMV Intervention | Active comparator | GMV Intervention: Group Medical Visits Receives: Behavioral: GMV Intervention |
| Usual Care | No intervention | Usual Care: Standard care for diabetic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores can be derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. The Diabetes Self-management Behaviors score is used in this study. For this score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior. Change is calculated as 1-year score minus baseline score.
Measured: Baseline and 1 year
Changes in Minutes of Moderate Physical Activity
A measure of patients' physical activity is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do physical activity? Like walking, house cleaning or gardening." Number of minutes may range from 0 to 10080, with greater number of minutes indicating more physical activity.
Measured: Baseline and 1 year
Changes in Minutes of Vigorous Exercise
A measure of patients' vigorous exercise is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do the kind of exercise that makes you breathe hard, such as swimming, walking fast, or biking?" Number of minutes may range from 0 to 10080, with greater number of minutes indicating more vigorous exercise.
Measured: Baseline and 1 year
Secondary outcomes (11)
Changes in Patient Assessment of Chronic Illness Care (PACIC)
The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past year that are aligned with the Chronic Care Model. The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support. Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score. Change is calculated as 1-year score minus baseline score.
Measured: Baseline and 1 year
Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project. The scale is designed to reflect patients' assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care). Respondents are asked how difficult over the past year has it been to follow exactly as their doctor who takes care of their diabetes suggested. Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy. Total scale score is calculated as the average across all items. Change is calculated as 1-year score minus baseline score.
Measured: Baseline and 1 year
Changes in Interpersonal Processes of Care (IPC) Scale
The Interpersonal Processes of Care (IPC) captures patient reports of providers' communication over the prior year. The scale is intended to measure patients' assessment of providers' communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness). Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score. Higher total scores indicate better communication. Change is calculated as 1-year score minus baseline score.
Measured: Baseline and 1 year
Changes in the Physical Component Summary of the SF-12 Health Survey
The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 1-year score minus baseline score.
Measured: Baseline and 1 year
Changes in the Mental Component Summary of the SF-12 Health Survey
The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 1-year score minus baseline score.
Measured: Baseline and 1 year
Number of Days Spent in Bed Due to Health Problems
A measure of patients' functional status is ascertained by asking patients the following question: "In the last 30 days, how many days did your health keep you in bed all or most of the day?" Number of days may range from 0 to 30, with lower number of days indicating better functional status.
Measured: 1 year
Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
A measure of diabetes interference on patients is ascertained by asking patients the following question: "In the last 12 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?" Responses consist of 6 possible options: "Always", "Almost Always", "Often", "Sometimes", "Almost Never", and "Never". These responses are grouped into 2 categories, with one category consisting of "Always", "Almost Always", and "Often" responses while the other category consists of the remaining responses. The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.
Measured: 1 year
Changes in Hemoglobin A1c Levels
Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement. Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease. Change is calculated as 1-year level minus baseline level.
Measured: Baseline and 1 year
Changes in Systolic Blood Pressure (SBP)
Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body. Change is calculated as 1-year pressure minus baseline pressure.
Measured: Baseline and 1 year
Changes in Diastolic Blood Pressure (DBP)
Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood. Change is calculated as 1-year pressure minus baseline pressure.
Measured: Baseline and 1 year
Changes in Body Mass Index (BMI)
Body Mass Index (BMI) is a number calculated from a person's weight and height. BMI is defined as the individual's body mass divided by the square of their height. The formulae used produce a unit of measure of kg/m2. BMI provides an indicator of body fatness.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Collaborators
- The Commonwealth Fund, California HealthCare Foundation
- Responsible party
- Sponsor
- Investigators
- Dean Schillinger, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214474
- Sponsor's protocol ID
- 1R21HS014864-01
- Status last verified
- Feb 2013
- First submitted
- 19 Sep 2005
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schillinger D, Handley M, Wang F, Hammer H. Effects of self-management support on structure, process, and outcomes among vulnerable patients with diabetes: a three-arm practical clinical trial. Diabetes Care. 2009 Apr;32(4):559-66. doi: 10.2337/dc08-0787. Epub 2009 Jan 8.
PubMed 19131469
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Efforts Across Language and Literacy (IDEALL)
- ClinicalTrials.gov ID
- NCT00214474
- Acronym / sponsor ID
- 1R21HS014864-01
- Conditions
- Diabetes
- Keywords
- Disease Management, Health Literacy, Telephone Care, Group Medical Visits, Type 2 Diabetes, Access to Care, Technology, Language Barriers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Collaborators
- The Commonwealth Fund, California HealthCare Foundation
- Study start
- Nov 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 22 Sep 2005 (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.
The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm randomized controlled trial to explore contextual factors at the patient, clinician, and organizational level of two patient self-management support strategies. A communication technology-based intervention (automated telephone diabetes management) and an interpersonally-oriented intervention (group medical visits)will be compared to usual care for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net health centers in the University of California, San Francisco (UCSF) Collaborative Research Network.
Detailed description
See above
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ATSM Intervention | Active comparator | Behavioral: ATSM InterventionATSM Intervention: Automated Telephone Self-Management Support |
| GMV Intervention | Active comparator | Behavioral: GMV InterventionGMV Intervention: Group Medical Visits |
| Usual Care | No intervention | –Usual Care: Standard care for diabetic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- have type 2 diabetes
- have a HbA1c equal to or > 8.0%
- must speak English, Spanish, or Cantonese.
Key exclusion criteria (3 listed)
- Dementia
- Psychosis/Schizophrenia
- End Stage Renal Disease
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 |
|---|---|---|
| ATSM InterventionAlso: ATSM: Automated Telephone Self-Management SupportParticipants randomized to ATSM Intervention received weekly, automated (pre-recorded) telephone calls over 39 weeks (9 months). Patient responses triggered either immediate, automated health education messages and/or subsequent nurse phone follow-up. | Behavioural | ATSM Intervention |
| GMV InterventionAlso: GMV: Group Medical VisitsGMV Intervention involved 90-minute monthly sessions over 9 months, involving 6-10 participants, co-facilitated by a primary care physician and health educator. | Behavioural | GMV Intervention |
Primary outcome
Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
Time frame: Baseline and 1 year
The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure's author's recommendations, two separate scores can be derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. The Diabetes Self-management Behaviors score is used in this study. For this score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior. Change is calculated as 1-year score minus baseline score.
Changes in Minutes of Moderate Physical Activity
Time frame: Baseline and 1 year
A measure of patients' physical activity is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do physical activity? Like walking, house cleaning or gardening." Number of minutes may range from 0 to 10080, with greater number of minutes indicating more physical activity.
Changes in Minutes of Vigorous Exercise
Time frame: Baseline and 1 year
A measure of patients' vigorous exercise is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do the kind of exercise that makes you breathe hard, such as swimming, walking fast, or biking?" Number of minutes may range from 0 to 10080, with greater number of minutes indicating more vigorous exercise.
11 secondary outcomes
Changes in Patient Assessment of Chronic Illness Care (PACIC)
Time frame: Baseline and 1 year
Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
Time frame: Baseline and 1 year
Changes in Interpersonal Processes of Care (IPC) Scale
Time frame: Baseline and 1 year
Changes in the Physical Component Summary of the SF-12 Health Survey
Time frame: Baseline and 1 year
Changes in the Mental Component Summary of the SF-12 Health Survey
Time frame: Baseline and 1 year
Number of Days Spent in Bed Due to Health Problems
Time frame: 1 year
Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
Time frame: 1 year
Changes in Hemoglobin A1c Levels
Time frame: Baseline and 1 year
Changes in Systolic Blood Pressure (SBP)
Time frame: Baseline and 1 year
Changes in Diastolic Blood Pressure (DBP)
Time frame: Baseline and 1 year
Changes in Body Mass Index (BMI)
Time frame: Baseline and 1 year
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 13 Feb 2013.
- Derived from this study: PubMed 19131469Schillinger D, Handley M, Wang F, Hammer H. Effects of self-management support on structure, process, and outcomes among vulnerable patients with diabetes: a three-arm practical clinical trial. Diabetes Care. 2009 Apr;32(4):559-66. doi: 10.2337/dc08-0787. Epub 2009 Jan 8.
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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.
Dean Schillinger, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATSM Intervention and GMV Intervention in people with Diabetes, run by Agency for Healthcare Research and Quality (AHRQ) 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 3 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 13 Feb 2013. 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?
Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale (time frame: Baseline and 1 year). The study lists 3 primary outcomes in all. 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 NCT00214474, which also lists 1 linked publication.
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 13 Feb 2013.