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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02471794
Other study ID # Pro00063493
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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