Clinical trial NCT02471794: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes
Keywords: Type II Diabetes
Personalized Health Planning
Shared Medical Appointments
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Feasibility measured using a patient satisfaction survey
timeFrame: 12 months
measure: Change in patient activation measured using the patient activation measure
timeFrame: baseline; 6 months; 12 months
measure: Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale
timeFrame: baseline; 6 months; 12 months
measure: Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale
timeFrame: baseline; 6 months; 12 months
measure: Change in A1C using the A1C blood test
timeFrame: baseline; 3 months; 6 months; 9 months; 12 months
Secondary outcomes:
measure: Change in depression screening score using the Patient Health Questionnaire (PHQ-9)
timeFrame: baseline; 6 months; 12 months
measure: Change in functional health and well-being using the short form health survey
timeFrame: baseline; 6 months; 12 months
measure: Change in general self-rated health using the general self rated health survey (GSRH)
timeFrame: baseline; 6 months; 12 months
measure: Change in health goal progress using a goal progress visual analog scale
timeFrame: 3 months; 10 months
measure: change in body mass index using weight and height measurements
timeFrame: baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
measure: change in blood pressure using blood pressure measurement
timeFrame: baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
measure: Change in low-density lipoprotein cholesterol (LDL) using LDL measurement
timeFrame: baseline; 6 months; 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Family Medicine Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Sharon Hull, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: