Back to resultsPersonalized Health Planning in Shared Medical Appointments for Individuals With Type II Diabetes Pilot Study
Primary Purpose
Type II Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Health Planning Shared Medical Appointment
Sponsored by
About this trial
This is an interventional prevention trial for Type II Diabetes focused on measuring Type II Diabetes, Personalized Health Planning, Shared Medical Appointments
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.
Sites / Locations
- Duke Family Medicine Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
No Intervention
Arm Label
Standard Shared Medical Appointment
Personalized Health Planning Shared Medical Appointment
Retrospective
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Feasibility measured using a patient satisfaction survey
Change in patient activation measured using the patient activation measure
Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale
Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale
Change in A1C using the A1C blood test
Secondary Outcome Measures
Change in depression screening score using the Patient Health Questionnaire (PHQ-9)
Change in functional health and well-being using the short form health survey
Change in general self-rated health using the general self rated health survey (GSRH)
Change in health goal progress using a goal progress visual analog scale
change in body mass index using weight and height measurements
change in blood pressure using blood pressure measurement
Change in low-density lipoprotein cholesterol (LDL) using LDL measurement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02471794
Brief Title
Personalized Health Planning in Shared Medical Appointments for Individuals With Type II Diabetes Pilot Study
Official Title
Personalized Health Planning in Shared Medical Appointments for Individuals With Type II
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes
Keywords
Type II Diabetes, Personalized Health Planning, Shared Medical Appointments
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Shared Medical Appointment
Arm Type
No Intervention
Arm Description
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.
Arm Title
Personalized Health Planning Shared Medical Appointment
Arm Type
Experimental
Arm Description
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.
Arm Title
Retrospective
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Health Planning Shared Medical Appointment
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility measured using a patient satisfaction survey
Time Frame
12 months
Title
Change in patient activation measured using the patient activation measure
Time Frame
baseline; 6 months; 12 months
Title
Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale
Time Frame
baseline; 6 months; 12 months
Title
Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale
Time Frame
baseline; 6 months; 12 months
Title
Change in A1C using the A1C blood test
Time Frame
baseline; 3 months; 6 months; 9 months; 12 months
Secondary Outcome Measure Information:
Title
Change in depression screening score using the Patient Health Questionnaire (PHQ-9)
Time Frame
baseline; 6 months; 12 months
Title
Change in functional health and well-being using the short form health survey
Time Frame
baseline; 6 months; 12 months
Title
Change in general self-rated health using the general self rated health survey (GSRH)
Time Frame
baseline; 6 months; 12 months
Title
Change in health goal progress using a goal progress visual analog scale
Time Frame
3 months; 10 months
Title
change in body mass index using weight and height measurements
Time Frame
baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
Title
change in blood pressure using blood pressure measurement
Time Frame
baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
Title
Change in low-density lipoprotein cholesterol (LDL) using LDL measurement
Time Frame
baseline; 6 months; 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Hull, MD MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Family Medicine Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Personalized Health Planning in Shared Medical Appointments for Individuals With Type II Diabetes Pilot Study
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