An interventional study of Personalized Health Planning Program Administration and Usual Care in Diabetes Mellitus, Health Behavior and Diabetes Mellitus, Type 2, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
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).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 92 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
A novel virtual group visit care model for individuals with T2D for long-term health improvements and disease management. This intervention group will receive a 16-week virtual, Personal Health Planning (PHP) T2D Program emphasizing behavioral engagement, utilizing a mixed methods research design. Outcomes include cardiometabolic labs and surveys.
Other: Personalized Health Planning Program Administration
The control group will receive usual care. They will be asked to have laboratory tests and answer survey questions regarding diabetes distress and diabetes empowerment.
Other: Usual Care
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.
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.
Hemoglobin A1c
Blood test to determine average blood sugar
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Attendance at Personalized Health Program Group Meetings
Time frame: 16 weeks
Diabetes Empowerment Scale
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
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Diabetes Distress
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
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Triglycerides
Triglycerides is a type of lipid measurement
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
HDL Cholesterol
HDL Cholesterol is a type of lipid measurement
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
LDL Cholesterol
LDL Cholesterol is a type of lipid measurement
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Total Cholesterol
Total Cholesterol is a type of lipid measurement
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Body Mass Index (BMI)
A measure of weight standardize for height to assess whether patient is considered normal, overweight, or obese
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Systolic Blood Pressure
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Diastolic Blood Pressure
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Hemoglobin A1c
Blood test to determine average blood sugar
Time frame: Month 17
Patient Goals Progress
Participant rated success based on a 1-5 likert scale, 5 being higher success rate
Time frame: Sessions 3-8 during the intervention
Fasting Plasma Glucose
Time frame: Day1 (preintervention), Month 5 (post intervention), Month 17 (1 year post intervention)
Diabetes Care Profile
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.
Time frame: Day 1 (preintervention)
Post Program Satisfaction
Post Program Satisfaction for intervention group only
Time frame: Month 5 (Postintervention)
Patient Goals
Patient selected diabetes management goals
Time frame: Obtained during sessions 3-8 during the intervention for the intervention group
Plan to share: No
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