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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02471794
Enrollment
33
Registered
2015-06-15
Start date
2015-12-31
Completion date
2016-09-30
Last updated
2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes

Keywords

Type II Diabetes, Personalized Health Planning, Shared Medical Appointments

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).

Interventions

BEHAVIORALPersonalized 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

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Feasibility measured using a patient satisfaction survey12 months
Change in patient activation measured using the patient activation measurebaseline; 6 months; 12 months
Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scalebaseline; 6 months; 12 months
Change in diabetes self efficacy using the 1-item diabetes self-efficacy scalebaseline; 6 months; 12 months
Change in A1C using the A1C blood testbaseline; 3 months; 6 months; 9 months; 12 months

Secondary

MeasureTime frame
change in blood pressure using blood pressure measurementbaseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
Change in depression screening score using the Patient Health Questionnaire (PHQ-9)baseline; 6 months; 12 months
Change in low-density lipoprotein cholesterol (LDL) using LDL measurementbaseline; 6 months; 12 months
Change in functional health and well-being using the short form health surveybaseline; 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 scale3 months; 10 months
change in body mass index using weight and height measurementsbaseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026