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Clinical Trials/NCT02471794
NCT02471794
Completed
Not Applicable

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

Duke University1 site in 1 country33 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type II Diabetes
Sponsor
Duke University
Enrollment
33
Locations
1
Primary Endpoint
Feasibility measured using a patient satisfaction survey
Status
Completed
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Feasibility measured using a patient satisfaction survey

Time Frame: 12 months

Change in patient activation measured using the patient activation measure

Time Frame: baseline; 6 months; 12 months

Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale

Time Frame: baseline; 6 months; 12 months

Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale

Time Frame: baseline; 6 months; 12 months

Change in A1C using the A1C blood test

Time Frame: baseline; 3 months; 6 months; 9 months; 12 months

Secondary Outcomes

  • 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)

Study Sites (1)

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