Personalized Health Planning in Shared Medical Appointments for Individuals With Type II Diabetes Pilot Study

Not Applicable

Completed

• Conditions: Type II Diabetes
• Interventions: Behavioral: Personalized Health Planning Shared Medical Appointment

• Registration Number: NCT02471794
• Lead Sponsor: Duke University

Brief Summary

The primary aim of this study is to examine the feasibility of implementing an evidence based patient engagement strategy, known as personalized health planning (PHP), in the context of a a shared medical appointment (SMA) for individuals with type II diabetes in a primary care setting.

Detailed Description

All data for the prospective portion of this study was done being collected in September 2016. The retrospective chart review will collect data up until March of 2017 (six months after the last subject completed the prospective phase by attending their last SMA session).

Study Timeline

• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-15
• Study Start: 2015-12
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• A diagnosis of Type 2 diabetes within the last year
• A current patient at Duke Family Medicine.
• An A1C score greater than 7 and less than 14.

Exclusion Criteria

• A diagnosis of Pre-diabetes
• A diagnosis of Type I diabetes
• Individuals with amputations as a result of their diabetes are excluded form this study.
• Individuals with renal dialysis will not be included in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized Health Planning Shared Medical Appointment	Personalized Health Planning Shared Medical Appointment	The PHP SMA group will combine personalized health planning with a modified version of the standard shared diabetes medical appointment. Modifications include: a self-assessment of health status, greater emphasis on a collaborative patient-provider health goal-setting process, a plan to meet goals, a mindfulness practice included in each session, and the creation of a 'personalized health plan' participant notebook for each individual to document health goals and track progress to review at each session. The participant notebook also includes educational handouts and worksheets to complement the educational curriculum.

Primary Outcome Measures

Name	Time	Method
Feasibility measured using a patient satisfaction survey	12 months
Change in patient activation measured using the patient activation measure	baseline; 6 months; 12 months
Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale	baseline; 6 months; 12 months
Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale	baseline; 6 months; 12 months
Change in A1C using the A1C blood test	baseline; 3 months; 6 months; 9 months; 12 months

Secondary Outcome Measures

Name	Time	Method
Change in depression screening score using the Patient Health Questionnaire (PHQ-9)	baseline; 6 months; 12 months
Change in functional health and well-being using the short form health survey	baseline; 6 months; 12 months
Change in general self-rated health using the general self rated health survey (GSRH)	baseline; 6 months; 12 months
Change in health goal progress using a goal progress visual analog scale	3 months; 10 months
change in body mass index using weight and height measurements	baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
change in blood pressure using blood pressure measurement	baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
Change in low-density lipoprotein cholesterol (LDL) using LDL measurement	baseline; 6 months; 12 months

Trial Locations

Locations (1)

Duke Family Medicine Center; 🇺🇸 Durham, North Carolina, United States