Diabetes Mellitus, Diabetes Mellitus, Type 2, Group Meetings, Health Behavior
Conditions
Brief summary
The primary objective of the study is to evaluate implementation and determine the effectiveness of a telehealth personal health planning program for individuals with uncontrolled Type 2 Diabetes Mellitus. For this study, participants will be randomized into either the Telehealth Program or the standard of care group. The personal health planning (PHP) Type 2 Diabetes program is a virtual, 8 session/16- week behavioral health program. The program includes development of a personal health plan supported by a patient-provider health risk assessment; group session structure supplemented by educational, on-demand video sessions; lessons, discussions, and activities based on understanding behavioral modification, health engagement, and diabetes distress; goal progress tracking; social support; mindful awareness practices; 3 and 6-month post program sessions and qualitative health evaluations via surveys and a one-on-one consultation with a personal health coach. Those in the control group will receive usual care by the participants personal care team. All participants will come to the Duke Research at Pickett Road facility for a pre and post-program fasting A1C and lipid panel blood draw (if required).
Interventions
OTHERPersonalized Health Planning Program Administration
The T2D PHP program is 8 hour-long sessions offered over 16 weeks. The program includes development of a personal health plan supported by a patient-provider health risk assessment; group session structure supplemented by educational, video sessions; lessons, discussions, and activities based on behavioral modification, health engagement, and diabetes distress; goal progress tracking; social support; mindful awareness practices and qualitative health evaluations via surveys and a one-on-one consultation with a personal health coach. Participants will be provided a group participant notebook that provides information discussed during the program. The T2D PHP program is a complement to routine care.
OTHERUsual Care
Patients will be encouraged to see their diabetes provider. Patients will not participate in the T2D PHP program but will complete laboratory tests and surveys as listed in the section on outcomes.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized controlled trial with intervention receiving a 16 week personalized health plan and control group receiving usual care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes diagnosis * 18 and over * 2 A1C results in last 18 months * A1C of 8-12 * Access to a electronic device with internet * Duke Patient
Exclusion criteria
* Type 1 Diabetes * Pregnant * Blind * Deaf * Cognitive Impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | Day 1 (Preintervention) and Month 5 (Postintervention) | Blood test to determine average blood sugar |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL Cholesterol | Day 1 (Preintervention) and Month 5 (Postintervention) | LDL Cholesterol is a type of lipid measurement |
| Hemoglobin A1c | Month 17 | Blood test to determine average blood sugar |
| Patient Goals Progress | Sessions 3-8 during the intervention | Participant rated success based on a 1-5 likert scale, 5 being higher success rate |
| Fasting Plasma Glucose | Day1 (preintervention), Month 5 (post intervention), Month 17 (1 year post intervention) | — |
| Attendance at Personalized Health Program Group Meetings | 16 weeks | — |
| Diabetes Empowerment Scale | Day 1 (Preintervention) and Month 5 (Postintervention) | The Diabetes Empowerment Scale (DES) is a tool designed to measure the psychosocial self-efficacy of people with diabetes. It helps assess how confident individuals feel about managing their diabetes and making necessary lifestyle changes. The DES consists of 28 items divided into three subscales: Managing the Psychosocial Aspects of Diabetes, Assessing Dissatisfaction and Readiness to Change, Setting and Achieving Goals. Each item on the DES is rated on a 5-point Likert scale, with 1 indicating strongly disagree and 5 indicating strongly agree. Total score is obtained by dividing by number of questions answered so total score range would be 1-5. Higher scores indicate greater empowerment and confidence in managing diabetes. Lower scores suggest areas where the individual may need more support or education |
| Diabetes Distress | Day 1 (Preintervention) and Month 5 (Postintervention) | The Diabetes Distress Scale (DDS) is a tool designed to measure the emotional burden and stress associated with managing diabetes. It consists of 17 items that assess various aspects of diabetes-related distress over the past month 1. Each item, subdomain scale, and total scale is rated on a 6-point scale, ranging from 1 (not a problem) to 6 (a very serious problem). The subdomains are: Emotional Burden Physician-related Distress Regimen-related Distress Interpersonal Distress |
| Triglycerides | Day 1 (Preintervention) and Month 5 (Postintervention) | Triglycerides is a type of lipid measurement |
| HDL Cholesterol | Day 1 (Preintervention) and Month 5 (Postintervention) | HDL Cholesterol is a type of lipid measurement |
| Total Cholesterol | Day 1 (Preintervention) and Month 5 (Postintervention) | Total Cholesterol is a type of lipid measurement |
| Body Mass Index (BMI) | Day 1 (Preintervention) and Month 5 (Postintervention) | A measure of weight standardize for height to assess whether patient is considered normal, overweight, or obese |
| Systolic Blood Pressure | Day 1 (Preintervention) and Month 5 (Postintervention) | — |
| Diastolic Blood Pressure | Day 1 (Preintervention) and Month 5 (Postintervention) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Goals | Obtained during sessions 3-8 during the intervention for the intervention group | Patient selected diabetes management goals |
| Post Program Satisfaction | Month 5 (Postintervention) | Post Program Satisfaction for intervention group only |
| Diabetes Care Profile | Day 1 (preintervention) | The DCP is a self-administered questionnaire that assesses the social and psychological factors related to diabetes and its treatment. The instrument contains 234 items and sixteen scales. These scales assess diabetes attitudes, diabetes beliefs, self-reported diabetes self-care, and difficulties with diabetes mgt. IT will be administered pre intervention to personalize each individual's care plan. |
Countries
United States
Outcome results
None listed