Clinical trial NCT06988540: T2D Pilot Study for Patients With Uncontrolled Type 2 Diabetes
Official title: Evaluation of a Telehealth Personal Health Planning Program for Patients With Uncontrolled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Health Behavior
Diabetes Mellitus, Type 2
Group Meetings
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with intervention receiving a 16 week personalized health plan and control group receiving usual care
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Day 1 (Preintervention) and Month 5 (Postintervention)
Secondary outcomes:
measure: Attendance at Personalized Health Program Group Meetings
timeFrame: 16 weeks
measure: Diabetes Empowerment Scale
timeFrame: Day 1 (Preintervention) and Month 5 (Postintervention)
measure: Diabetes Distress
timeFrame: Day 1 (Preintervention) and Month 5 (Postintervention)
measure: Triglycerides
timeFrame: Day 1 (Preintervention) and Month 5 (Postintervention)
measure: HDL Cholesterol
timeFrame: Day 1 (Preintervention) and Month 5 (Postintervention)
measure: LDL Cholesterol
timeFrame: Day 1 (Preintervention) and Month 5 (Postintervention)
measure: Total Cholesterol
timeFrame: Day 1 (Preintervention) and Month 5 (Postintervention)
measure: Body Mass Index (BMI)
timeFrame: Day 1 (Preintervention) and Month 5 (Postintervention)
measure: Systolic Blood Pressure
timeFrame: Day 1 (Preintervention) and Month 5 (Postintervention)
measure: Diastolic Blood Pressure
timeFrame: Day 1 (Preintervention) and Month 5 (Postintervention)
measure: Hemoglobin A1c
timeFrame: Month 17
measure: Patient Goals Progress
timeFrame: Sessions 3-8 during the intervention
measure: Fasting Plasma Glucose
timeFrame: Day1 (preintervention), Month 5 (post intervention), Month 17 (1 year post intervention)
Other outcomes:
measure: Diabetes Care Profile
timeFrame: Day 1 (preintervention)
measure: Post Program Satisfaction
timeFrame: Month 5 (Postintervention)
measure: Patient Goals
timeFrame: Obtained during sessions 3-8 during the intervention for the intervention group
Locations:
city: Durham
country: United States
facility: Duke Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Susan E Spratt, MD
role: PRINCIPAL_INVESTIGATOR
References: