T2D Pilot Study for Patients With Uncontrolled Type 2 Diabetes

Duke University

Status: Completed

Conditions: Diabetes Mellitus; Health Behavior; Diabetes Mellitus, Type 2; Group Meetings

Treatments: Other: Personalized Health Planning Program Administration; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06988540

Pro00110685

Details and patient eligibility

About

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).

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

92 participants in 2 patient groups, including a placebo group

Personalized Health Planning Program Participant with Type 2 Diabetes

Experimental group

Description:

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.

Treatment:

Other: Personalized Health Planning Program Administration

Usual Care (Type 2 DM)

Placebo Comparator group

Description:

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.

Treatment:

Other: Usual Care