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Comparing Strategies for Translating Self-management Support Into Primary Care

Not Applicable
Completed
Conditions
Diabetes Mellitus, Type 2
Registration Number
NCT01945918
Lead Sponsor
University of Colorado, Denver
Brief Summary

This project will test different ways of helping primary care practices to do a better job of self-management support (SMS) for their patients with diabetes.

Detailed Description

The specific aims of the proposed study are:

* Primary Specific Aims

1. To conduct a cluster randomized trial to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of Connection to Health (CTH) for patients with type 2 diabetes in primary care practice settings. Primary effectiveness outcomes will include hemoglobin A1c, Body Mass Index (BMI), blood pressure and Low Desity Lipprotein (LDL) cholesterol.

2. To determine the incremental benefit, using the RE-AIM framework, of brief targeted practice coaching on the implementation of CTH in diverse primary care practices.

* Secondary Specific Aims

1. To identify key practice characteristics (e.g., practice size, organization, setting, and level of experience with practice redesign efforts) that impact CTH RE-AIM. These results will inform dissemination of the CTH intervention.

2. To determine the relative costs associated with implementing CTH and practice coaching to further inform dissemination efforts.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
901
Inclusion Criteria
  • Age 21 years old or over
  • Type 2 Diabetes Mellitus diagnosed for a minimum of 12 months
  • Able to read in English or Spanish
  • Plan to remain in the practice during the study period
Exclusion Criteria
  • Developmentally disabled
  • Decisionally challenged
  • Pregnant women

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in LDL from baseline to 18 months18 months from baseline

Low-density lipoprotein (LDL) cholesterol will be measured at baseline and 18 months from baseline (in mg/dL; e.g., 160 mg/dL).

Change in HbA1c from baseline to 18 months18 months from baseline

Glycosylated hemoglobin (HbA1c) will be measured at baseline and 18 months from baseline.

Change in body mass index (BMI) from baseline to 18 months18 months from baseline

Body mass index (BMI) will be measured at baseline and 18 months from baseline (weight (kg) / \[height (m)\]2; e.g., 24.96)

Change in systolic and diastolic blood pressure from baseline to 18 months18 months from baseline

Systolic and diastolic blood pressure will be measured at baseline and 18 months from baseline (in mmHg; e.g., 140/90 mmHg)

Secondary Outcome Measures
NameTimeMethod
Evidence of documented self-management support for patients through medical record review18 months from baseline

The following elements will be assessed in medical record review: presence of a personal care plan with regular updating, evidence of collaborative goal setting, evidence of action planning around prioritized patient goals, evidence of collaborative problem-solving regarding the action planning process, use of community resources to assist in goal attainment, and evidence of ongoing monitoring of progress on identified goals. A total score will be the sum of positive elements.

Trial Locations

Locations (1)

University of Colorado at Denver and Health Sciences Center

🇺🇸

Aurora, Colorado, United States

University of Colorado at Denver and Health Sciences Center
🇺🇸Aurora, Colorado, United States

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