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

NCT ID: NCT02471794

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-09-30

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).

Conditions

Type II Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Shared Medical Appointment

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Personalized Health Planning Shared Medical Appointment

Intervention Type: 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

Retrospective

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Hull, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Family Medicine Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00063493

Identifier Type: -

Identifier Source: org_study_id