Clinical trial NCT01945918: Comparing Strategies for Translating Self-management Support Into Primary Care
Official title: Comparing Strategies for Translating Self-management Support Into Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Diabetes Mellitus
Primary Health Care
Self care
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-09-19
Enrollment: 901
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c from baseline to 18 months
timeFrame: 18 months from baseline
measure: Change in LDL from baseline to 18 months
timeFrame: 18 months from baseline
measure: Change in systolic and diastolic blood pressure from baseline to 18 months
timeFrame: 18 months from baseline
measure: Change in body mass index (BMI) from baseline to 18 months
timeFrame: 18 months from baseline
Secondary outcomes:
measure: Evidence of documented self-management support for patients through medical record review
timeFrame: 18 months from baseline
Other outcomes:
measure: Change in patient-reported dietary intake of saturated fat, fruits and vegetables, salt, and sweetened beverages baseline to 18 months
timeFrame: 18 months from baseline
measure: Change in patient-reported physical activity from baseline to 18 months
timeFrame: 18 months from baseline
measure: Change in patient-reported tobacco use from baseline to 18 months
timeFrame: 18 months from baseline
measure: Change in patient-reported medication adherence from baseline to 18 months
timeFrame: 18 months from baseline
measure: Change in patient-reported disease-related distress rating from baseline to 18 months
timeFrame: 18 months from baseline
measure: Change in patient-reported diabetes self-care rating from baseline to 18 months
timeFrame: 18 months from baseline
Locations:
city: Aurora
country: United States
facility: University of Colorado at Denver and Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: W. Perry Dickinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hessler DM, Fisher L, Bowyer V, Dickinson LM, Jortberg BT, Kwan B, Fernald DH, Simpson M, Dickinson WP. Self-management support for chronic disease in primary care: frequency of patient self-management problems and patient reported priorities, and alignment with ultimate behavior goal selection. BMC Fam Pract. 2019 Aug 29;20(1):120. doi: 10.1186/s12875-019-1012-x.
citation: Dickinson WP, Dickinson LM, Jortberg BT, Hessler DM, Fernald DH, Fisher L. A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices. BMC Fam Pract. 2018 Jul 24;19(1):126. doi: 10.1186/s12875-018-0810-x.