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Completed

NCT Number: NCT02471794

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

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.

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Key information

Conditions

Type II Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Family Medicine Center

Durham, North Carolina, 27705, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Feasibility measured using a patient satisfaction survey

    Time frame: 12 months

  2. Change in patient activation measured using the patient activation measure

    Time frame: baseline; 6 months; 12 months

  3. Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale

    Time frame: baseline; 6 months; 12 months

  4. Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale

    Time frame: baseline; 6 months; 12 months

  5. Change in A1C using the A1C blood test

    Time frame: baseline; 3 months; 6 months; 9 months; 12 months

Secondary outcomes

  1. Change in depression screening score using the Patient Health Questionnaire (PHQ-9)

    Time frame: baseline; 6 months; 12 months

  2. Change in functional health and well-being using the short form health survey

    Time frame: baseline; 6 months; 12 months

  3. Change in general self-rated health using the general self rated health survey (GSRH)

    Time frame: baseline; 6 months; 12 months

  4. Change in health goal progress using a goal progress visual analog scale

    Time frame: 3 months; 10 months

  5. 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

  6. 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

  7. Change in low-density lipoprotein cholesterol (LDL) using LDL measurement

    Time frame: baseline; 6 months; 12 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 15, 2015
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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