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

Type II Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471794
• Other study ID #: Pro00063493
• Status: Completed
• Phase: N/A
• First received: June 11, 2015
• Last updated: January 23, 2017
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Duke Family Medicine Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measured using a patient satisfaction survey		12 months
Primary	Change in patient activation measured using the patient activation measure		baseline; 6 months; 12 months
Primary	Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale		baseline; 6 months; 12 months
Primary	Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale		baseline; 6 months; 12 months
Primary	Change in A1C using the A1C blood test		baseline; 3 months; 6 months; 9 months; 12 months
Secondary	Change in depression screening score using the Patient Health Questionnaire (PHQ-9)		baseline; 6 months; 12 months
Secondary	Change in functional health and well-being using the short form health survey		baseline; 6 months; 12 months
Secondary	Change in general self-rated health using the general self rated health survey (GSRH)		baseline; 6 months; 12 months
Secondary	Change in health goal progress using a goal progress visual analog scale		3 months; 10 months
Secondary	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
Secondary	change in blood pressure using blood pressure measurement		baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
Secondary	Change in low-density lipoprotein cholesterol (LDL) using LDL measurement		baseline; 6 months; 12 months