Diabetes Mellitus, Type 2EIA-DiabetesNCT05173675
Empathy in Action: Sunshine Calls for Life With Diabetes
A study testing Empathy in Action for life with diabetes. in people with Diabetes Mellitus, Type 2 and Diabetes, run by University of Texas at Austin at 9 sites in United States.
Trial summary
Randomized controlled trial of the effectiveness in managing diabetes and improving mental health through a telephonic layperson-delivered empathy and relationship-focused program for patients at a Federally Qualified Health Center (FQHC) against usual care. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes, Mental Health
- What is being tested?
- Empathy in Action for life with diabetes.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Feb 2022to 29 Apr 2024
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c ≥ 7.5% at baseline measurement and 8.0% at least one time 12 months prior to study enrollment.
- At least one visit with Lone Star Circle of Care within the past 12 months (in person or telehealth)
- Willing to answer the PHQ-9 form in its entirety at baseline data collection (due to stratified randomization design).
Who cannot join
- HbA1c < 7.5% at baseline measurement.
- Refusal to answer the PHQ-9 form in its entirety at baseline data collection.
- Moderate to severe cognitive impairment
- Currently pregnant (if of female sex)
- Undergoing cancer treatment
- Having diagnosis of end-stage renal disease or serious mental illness
- Having moderate to severe cognitive impairment
- Receiving systemic treatment with prednisone or immunosuppressant therapy following an organ transplant
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Lone Star Circle of Care at Ben White Health Clinic
Austin, Texas, 78704
Lone Star Circle of Care at El Buen Samaritano
Austin, Texas, 78745
Lone Star Circle of Care at Collinfield
Austin, Texas, 78758
Lone Star Circle of Care at Northwest Austin
Austin, Texas, 78759
Lone Star Circle of Care at Bastrop
Bastrop, Texas, 78602
Lone Star Circle of Care at Cedar Park
Cedar Park, Texas, 78613
Lone Star Circle of Care at Lake Aire Medical Center
Georgetown, Texas, 78628
Lone Star Circle of Care at Pflugerville
Pflugerville, Texas, 78660
Lone Star Circle of Care at Texas A&M Health Science Center
Round Rock, Texas, 78665
About this study
Randomized controlled trial of the effectiveness in managing diabetes and improving mental health through a telephonic layperson-delivered empathy and relationship-focused program for patients at a Federally Qualified Health Center (FQHC) against usual care.
Read the detailed description
In this study, we will assess the effectiveness of a 6-month program delivered by phone by lightly-trained lay people to individuals with diabetes, with the goal of empathetic relationship building and engagement to support day-to-day challenges of managing diabetes and working towards self-management goals. We will recruit from a collaborating Federally Qualified Health Center (FQHC) and use a randomized controlled trial, comparing program to usual care. Telephone callers will be lay people (no formal health training) who will be recruited for authentic interest and empathetic skills and lightly trained on conversational skills, cultural nuances, and how best to support people's individual lifestyle goals on nutrition, exercise, sleep and medication adherence. Callers will encourage participants to seek additional help from their clinic or specific social services as needs arise that benefit from early escalation.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes, Mental Health, Health Behavior
- Being tested
- Empathy in Action for life with diabetes., Control Phase 2 Materials Only
- Keywords
- Telephone, Empathy, Layperson, Self-Management, Incentives
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Psychological Well-Being, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empathy in Action for life with diabetes.Behavioural
In Phase 1 (Months 1-6) participants receive ("Program"):
- Empathetic communications: A dedicated partner (lightly-trained lay person) who communicates with them via phone with timing and frequency defined by the participant within certain parameters. Two letters mailed during the 6 months that compile anonymized learnings from all participants in the callers panel of 10-20 participants, written as a newsletter to share back with the participant.
- Material Incentives: One choice of health tool (weight scale or pedometer) selected with the caller in week 1 and expected to be received in weeks 3-5. Two small recognition gifts (valued at US$25) chosen by the caller based on their understanding of the participants preferences, and sent at month 2.5 and 4.5.
- Educational Materials: Printed DM management educational materials mailed right after enrollment and randomization, and expected to be received in weeks 1-2.
Control Phase 2 Materials OnlyBehavioural
- Material Incentives:
- Choice of health tool (weight scale or pedometer) and 2 health promoting gifts chosen by the caller at the end of their 6 month measurement visit.
- Health tool is mailed out within the 7th month ii. Health promoting gifts are mailed out in the 8th and 10th month
- Educational Materials a. The same educational materials mailed to participants in the intervention arm "Program" will be mailed to control arm participants after they complete their 6 months visit
| Study group | Role | What they receive |
|---|---|---|
| Program arm | Experimental | Usual Care+
Phase 1 (6 months, months 1-6), Program. Includes empathetic communications (phone \& letter), health-promoting incentives, educational materials.
Phase 2 (6 months, months 7-12) No Program. During this follow-up period they will receive monthly SMS texts with customized messages encouraging health promoting behaviors. Receives: Behavioral: Empathy in Action for life with diabetes. |
| Control arm | Other | Usual Care+
Phase 1 (6 months, months 1-6), No Program.
Phase 2 (6 months, months 7-12) Material components of program including health-promoting incentives and educational materials. Receives: Behavioral: Control Phase 2 Materials Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C (HbA1c)
Finger stick point-of-care portable device
Measured: 6 months
Secondary outcomes (9)
Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9)
Self-administered. Based on the nine DSM-V criteria listed under criterion A for Major Depressive Disorder. Responders are asked to rate the frequency of depression symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (Nearly every day). Items are summed to provide a total score (0-27). The total score serves as a marker of severity and distress (5-9 minimal depressive symptoms; 10-14 minor depression or dysthymia; 15-27 major depressive symptoms).
Measured: 6 months
Diastolic and systolic blood pressure (mmHg)
Direct measurement with automatic blood pressure cuff
Measured: 6 months
Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)
Self-administered. Based on some of the DSM-V criteria for General Anxiety Disorder to identify probable cases of GAD along with measuring anxiety symptom severity. Responders are asked to rate the frequency of anxiety symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed to provide a total score (0-21) to inform severity (1-4 minimal symptoms; 5-9 mild symptoms; 10-14 moderate symptoms; 15-21 severe symptoms).
Measured: 6 months
General health/quality of life as measured by scores on the MOS Short-form 12-item (SF-12)
Self-administered. Measures physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health.
Measured: 6 months
Medication adherence as measured by scores on the Medication Adherence Report Scale 5-item (MARS-5)
Self-administered. It asks respondents to rate the frequency with which the five different medication-taking behaviors occur. Each items is scored on a five-point scale (5 = never, 4 = rarely, 3 = sometimes, 2 = often, 1 = very often), with higher scores indicating higher reported adherence.
Measured: 6 months
Perceived Diabetes Self-Management Scale (PDSMS)
Self-administered. The responses for the 8 items PDSMS items range from 1 = "Strongly Disagree" to 5 = "Strongly Agree." The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.
Measured: 6 months
Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item
Self-Administered. Respondents are asked to score their level of confidence (scale from 1, not at all confident, to 10, totally confident) at the present time in doing tasks related to diabetes management (e.g., diet behavior, physical activity, measuring blood glycemia and others). Higher scores indicate higher self-efficacy.
Measured: 6 months
Loneliness measured by scores on the 3-item UCLA Loneliness Scale
Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.
Measured: 6 months
Diabetes distress measured by the 2-item Diabetes Distress Screening Scale
The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. Higher scores suggest higher diabetes distress.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start12 Feb 2022
- Primary completion20 Nov 2023
- Study completion29 Apr 2024
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Model description
- Randomized controlled trial, stratified by PHQ-9 baseline scores (cut-off ≥5), on a 1:1 ratio
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Lone Star Circle of Care
- Responsible party
- Principal investigator, Maninder Kahlon, University of Texas at Austin
- Investigators
- Maninder Kahlon, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173675
- Sponsor's protocol ID
- STUDY00001571
- Acronym
- EIA-Diabetes
- Status last verified
- May 2024
- First submitted
- 2 Dec 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kahlon MK, Aksan NS, Aubrey R, Clark N, Cowley-Morillo M, DuBois C, Garcia C, Guerra J, Pereira D, Sither M, Tomlinson S, Valenzuela S, Valdez MR. Glycemic Control With Layperson-Delivered Telephone Calls vs Usual Care for Patients With Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2448809. doi: 10.1001/jamanetworkopen.2024.48809.
PubMed 39656459
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empathy in Action: Sunshine Calls for Life With Diabetes
- ClinicalTrials.gov ID
- NCT05173675
- Acronym / sponsor ID
- EIA-Diabetes / STUDY00001571
- Conditions
- Diabetes Mellitus, Type 2, Diabetes, Mental Health, Health Behavior
- Keywords
- Telephone, Empathy, Layperson, Self-Management, Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Lone Star Circle of Care
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 30 Dec 2021 (actual)
- 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.
Randomized controlled trial of the effectiveness in managing diabetes and improving mental health through a telephonic layperson-delivered empathy and relationship-focused program for patients at a Federally Qualified Health Center (FQHC) against usual care.
Detailed description
In this study, we will assess the effectiveness of a 6-month program delivered by phone by lightly-trained lay people to individuals with diabetes, with the goal of empathetic relationship building and engagement to support day-to-day challenges of managing diabetes and working towards self-management goals. We will recruit from a collaborating Federally Qualified Health Center (FQHC) and use a randomized controlled trial, comparing program to usual care. Telephone callers will be lay people (no formal health training) who will be recruited for authentic interest and empathetic skills and lightly trained on conversational skills, cultural nuances, and how best to support people's individual lifestyle goals on nutrition, exercise, sleep and medication adherence. Callers will encourage participants to seek additional help from their clinic or specific social services as needs arise that benefit from early escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, stratified by PHQ-9 baseline scores (cut-off ≥5), on a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Program arm | Experimental | Behavioral: Empathy in Action for life with diabetes.Usual Care+ Phase 1 (6 months, months 1-6), Program. Includes empathetic communications (phone \& letter), health-promoting incentives, educational materials. Phase 2 (6 months, months 7-12) No Program. During this follow-up period they will receive monthly SMS texts with customized messages encouraging health promoting behaviors. |
| Control arm | Other | Behavioral: Control Phase 2 Materials OnlyUsual Care+ Phase 1 (6 months, months 1-6), No Program. Phase 2 (6 months, months 7-12) Material components of program including health-promoting incentives and educational materials. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HbA1c ≥ 7.5% at baseline measurement and 8.0% at least one time 12 months prior to study enrollment.
- At least one visit with Lone Star Circle of Care within the past 12 months (in person or telehealth)
- Willing to answer the PHQ-9 form in its entirety at baseline data collection (due to stratified randomization design).
Key exclusion criteria (8 listed)
- HbA1c < 7.5% at baseline measurement.
- Refusal to answer the PHQ-9 form in its entirety at baseline data collection.
- Moderate to severe cognitive impairment
- Currently pregnant (if of female sex)
- Undergoing cancer treatment
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 |
|---|---|---|
| Empathy in Action for life with diabetes.In Phase 1 (Months 1-6) participants receive ("Program"): 1. Empathetic communications: A dedicated partner (lightly-trained lay person) who communicates with them via phone with timing and frequency defined by the participant within certain parameters. Two letters mailed during the 6 months that compile anonymized learnings from all participants in the callers panel of 10-20 participants, written as a newsletter to share back with the participant. 2. Material Incentives: One choice of health tool (weight scale or pedometer) selected with the caller in week 1 and expected to be received in weeks 3-5. Two small recognition gifts (valued at US$25) chosen by the caller based on their understanding of the participants preferences, and sent at month 2.5 and 4.5. 3. Educational Materials: Printed DM management educational materials mailed right after enrollment and randomization, and expected to be received in weeks 1-2. | Behavioural | Program arm |
| Control Phase 2 Materials Only1. Material Incentives: a. Choice of health tool (weight scale or pedometer) and 2 health promoting gifts chosen by the caller at the end of their 6 month measurement visit. i. Health tool is mailed out within the 7th month ii. Health promoting gifts are mailed out in the 8th and 10th month 2. Educational Materials a. The same educational materials mailed to participants in the intervention arm "Program" will be mailed to control arm participants after they complete their 6 months visit | Behavioural | Control arm |
Primary outcome
Hemoglobin A1C (HbA1c)
Time frame: 6 months
Finger stick point-of-care portable device
9 secondary outcomes
Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9)
Time frame: 6 months
Diastolic and systolic blood pressure (mmHg)
Time frame: 6 months
Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: 6 months
General health/quality of life as measured by scores on the MOS Short-form 12-item (SF-12)
Time frame: 6 months
Medication adherence as measured by scores on the Medication Adherence Report Scale 5-item (MARS-5)
Time frame: 6 months
Perceived Diabetes Self-Management Scale (PDSMS)
Time frame: 6 months
Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item
Time frame: 6 months
Loneliness measured by scores on the 3-item UCLA Loneliness Scale
Time frame: 6 months
Diabetes distress measured by the 2-item Diabetes Distress Screening Scale
Time frame: 6 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 7 May 2024.
- Derived from this study: PubMed 39656459Kahlon MK, Aksan NS, Aubrey R, Clark N, Cowley-Morillo M, DuBois C, Garcia C, Guerra J, Pereira D, Sither M, Tomlinson S, Valenzuela S, Valdez MR. Glycemic Control With Layperson-Delivered Telephone Calls vs Usual Care for Patients With Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2448809. doi: 10.1001/jamanetworkopen.2024.48809.
- 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.
Maninder Kahlon, PhD principal investigator
University of Texas at Austin
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empathy in Action for life with diabetes. in people with Diabetes Mellitus, Type 2 and Diabetes, run by University of Texas at Austin at 9 sites 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 8 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Hemoglobin A1C (HbA1c) (time frame: 6 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 NCT05173675, 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 7 May 2024.