Comparing Strategies for Translating Self-management Support Into Primary Care

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Comparing Strategies for Translating Self-management Support Into Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945918
• Other study ID #: 12-0645
• Secondary ID: 1R18DK096387-01
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: December 18, 2017
• Start date: October 2013
• Est. completion date: July 31, 2017

Study information

• Verified date: December 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 901
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Self-management support education
Same as Arm Description
• Connection to Health Interactive Behavior Change Technology
Same as Arm Description
• Connection to Health plus Coaching (CTH+C)
Same as Arm Description

Locations

Country	Name	City	State
United States	University of Colorado at Denver and Health Sciences Center	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in patient-reported dietary intake of saturated fat, fruits and vegetables, salt, and sweetened beverages baseline to 18 months	Patients' dietary intake of saturated fat, fruits and vegetables, salt, and sweetened beverages will be assessed at baseline and 18 months from baseline through a patient-completed survey on their diet.	18 months from baseline
Other	Change in patient-reported physical activity from baseline to 18 months	Patients' frequency and duration of participation in vigorous, moderate, and walking activity as well as "screen" time and time spent sitting will be assessed at baseline and 18 months from baseline through a patient-completed survey on their physical activity.	18 months from baseline
Other	Change in patient-reported tobacco use from baseline to 18 months	Patients' use of tobacco (whether or not using tobacco, if so, how much; e.g., current smoker [yes/no]; number of cigarettes [10 in the past week]) will be assessed at baseline and 18 months from baseline through a patient-completed survey.	18 months from baseline
Other	Change in patient-reported medication adherence from baseline to 18 months	Patients' prescribed medication adherence (number of days missed, reasons for missing) will be assessed at baseline and 18 months from baseline through a patient-completed survey.	18 months from baseline
Other	Change in patient-reported disease-related distress rating from baseline to 18 months	Patients' distress related to their diabetes (6-point scales for each item; mean score calculated for each sub-scale [range between 1 and 6]) will be assessed at baseline and 18 months from baseline through a patient-completed survey.	18 months from baseline
Other	Change in patient-reported diabetes self-care rating from baseline to 18 months	Patients' measure of the frequency of performing diabetes self-care tasks over the preceding 7 days will be assessed at baseline and 18 months from baseline through a patient-completed survey.	18 months from baseline
Primary	Change in HbA1c from baseline to 18 months	Glycosylated hemoglobin (HbA1c) will be measured at baseline and 18 months from baseline.	18 months from baseline
Primary	Change in LDL from baseline to 18 months	Low-density lipoprotein (LDL) cholesterol will be measured at baseline and 18 months from baseline (in mg/dL; e.g., 160 mg/dL).	18 months from baseline
Primary	Change in systolic and diastolic blood pressure from baseline to 18 months	Systolic and diastolic blood pressure will be measured at baseline and 18 months from baseline (in mmHg; e.g., 140/90 mmHg)	18 months from baseline
Primary	Change in body mass index (BMI) from baseline to 18 months	Body mass index (BMI) will be measured at baseline and 18 months from baseline (weight (kg) / [height (m)]2; e.g., 24.96)	18 months from baseline
Secondary	Evidence of documented self-management support for patients through medical record review	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.	18 months from baseline