Back to resultsEmpathy in Action: Sunshine Calls for Life With Diabetes (EIA-Diabetes)
Primary Purpose
Diabetes Mellitus, Type 2, Diabetes, Mental Health
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empathy in Action for life with diabetes.
Control Phase 2 Materials Only
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Telephone, Empathy, Layperson, Self-Management, Incentives
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
- Lone Star Circle of Care at Ben White Health Clinic
- Lone Star Circle of Care at El Buen Samaritano
- Lone Star Circle of Care at Collinfield
- Lone Star Circle of Care at Northwest Austin
- Lone Star Circle of Care at Bastrop
- Lone Star Circle of Care at Cedar Park
- Lone Star Circle of Care at Lake Aire Medical Center
- Lone Star Circle of Care at Pflugerville
- Lone Star Circle of Care at Texas A&M Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Program arm
Control arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Hemoglobin A1C (HbA1c)
Finger stick point-of-care portable device
Secondary Outcome Measures
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).
Diastolic and systolic blood pressure (mmHg)
Direct measurement with automatic blood pressure cuff
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).
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05173675
First Posted
December 2, 2021
Last Updated
May 9, 2023
Sponsor
University of Texas at Austin
Collaborators
Lone Star Circle of Care
1. Study Identification
Unique Protocol Identification Number
NCT05173675
Brief Title
Empathy in Action: Sunshine Calls for Life With Diabetes
Acronym
EIA-Diabetes
Official Title
Empathy in Action: Sunshine Calls for Life With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 12, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Lone Star Circle of Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes, Mental Health, Health Behavior
Keywords
Telephone, Empathy, Layperson, Self-Management, Incentives
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial, stratified by PHQ-9 baseline scores (cut-off ≥5), on a 1:1 ratio
Masking
InvestigatorOutcomes Assessor
Masking Description
Research staff responsible for biomedical data collection at the sites are blinded to the status of the participant as part of control or intervention group. Self-reported outcomes are reported by participants on a tablet.
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Program arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Empathy in Action for life with diabetes.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Phase 2 Materials Only
Intervention Description
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
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
Primary Outcome Measure Information:
Title
Hemoglobin A1C (HbA1c)
Description
Finger stick point-of-care portable device
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9)
Description
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).
Time Frame
6 months
Title
Diastolic and systolic blood pressure (mmHg)
Description
Direct measurement with automatic blood pressure cuff
Time Frame
6 months
Title
Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)
Description
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).
Time Frame
6 months
Title
General health/quality of life as measured by scores on the MOS Short-form 12-item (SF-12)
Description
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.
Time Frame
6 months
Title
Medication adherence as measured by scores on the Medication Adherence Report Scale 5-item (MARS-5)
Description
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.
Time Frame
6 months
Title
Perceived Diabetes Self-Management Scale (PDSMS)
Description
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.
Time Frame
6 months
Title
Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item
Description
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.
Time Frame
6 months
Title
Loneliness measured by scores on the 3-item UCLA Loneliness Scale
Description
Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.
Time Frame
6 months
Title
Diabetes distress measured by the 2-item Diabetes Distress Screening Scale
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maninder Kahlon, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lone Star Circle of Care at Ben White Health Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Lone Star Circle of Care at El Buen Samaritano
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Lone Star Circle of Care at Collinfield
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Lone Star Circle of Care at Northwest Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Lone Star Circle of Care at Bastrop
City
Bastrop
State/Province
Texas
ZIP/Postal Code
78602
Country
United States
Facility Name
Lone Star Circle of Care at Cedar Park
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Lone Star Circle of Care at Lake Aire Medical Center
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628
Country
United States
Facility Name
Lone Star Circle of Care at Pflugerville
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Lone Star Circle of Care at Texas A&M Health Science Center
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78665
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Empathy in Action: Sunshine Calls for Life With Diabetes
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