Skip to main content
OpenTrials
Completed

NCT Number: NCT01945918

Comparing Strategies for Translating Self-management Support Into Primary Care

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado at Denver and Health Sciences Center

Aurora, Colorado, 80045, United States

About this study

The specific aims of the proposed study are:

  • Primary Specific Aims
  • 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.
  • 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
  • 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.
  • To determine the relative costs associated with implementing CTH and practice coaching to further inform dissemination efforts.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Self-management support education

Behavioral

Same as Arm Description

Connection to Health Interactive Behavior Change Technology

Behavioral

Same as Arm Description

Connection to Health plus Coaching (CTH+C)

Behavioral

Same as Arm Description

Primary outcomes

  1. Change in HbA1c from baseline to 18 months

    Time frame: 18 months from baseline

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

  2. Change in LDL from baseline to 18 months

    Time frame: 18 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).

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

    Time frame: 18 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)

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

    Time frame: 18 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)

Secondary outcomes

  1. Evidence of documented self-management support for patients through medical record review

    Time frame: 18 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.

Other outcomes

  1. Change in patient-reported dietary intake of saturated fat, fruits and vegetables, salt, and sweetened beverages baseline to 18 months

    Time frame: 18 months from baseline

    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.

  2. Change in patient-reported physical activity from baseline to 18 months

    Time frame: 18 months from baseline

    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.

  3. Change in patient-reported tobacco use from baseline to 18 months

    Time frame: 18 months from baseline

    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.

  4. Change in patient-reported medication adherence from baseline to 18 months

    Time frame: 18 months from baseline

    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.

  5. Change in patient-reported disease-related distress rating from baseline to 18 months

    Time frame: 18 months from baseline

    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.

  6. Change in patient-reported diabetes self-care rating from baseline to 18 months

    Time frame: 18 months from baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of California, San Francisco

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2013
Registry last updated
Dec 20, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.