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

NCT02471794 | Completed

• 1 other identifier: Pro00063493
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Type II Diabetes

Keywords

Type II Diabetes; Personalized Health Planning; Shared Medical Appointments

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (3)

Standard Shared Medical Appointment

NO INTERVENTION

The SMA group will be a standard shared diabetes medical appointment group consisting of up to 10 patients that utilizes the design and curriculum of the SMAs that are currently being held at the Duke Family Medicine Center.

Personalized Health Planning Shared Medical Appointment

EXPERIMENTAL

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.

Behavioral: Personalized Health Planning Shared Medical Appointment

Retrospective

NO INTERVENTION

A retrospective chart review will be conducted once all participants (both SMA group and PHP SMA group) complete the intervention. The retrospective chart review will collect healthcare utilization data six months prior, during, and after each subject's participation in the SMA.

Interventions

Personalized Health Planning Shared Medical Appointment BEHAVIORAL

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

Personalized Health Planning Shared Medical Appointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Family Medicine Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sharon Hull, MD MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 15, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (1)