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Enhancing Self-Management Support in Diabetes Through Patient Engagement (EE-CTH)

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ClinicalTrials.gov Identifier: NCT02834923
Recruitment Status : Enrolling by invitation
First Posted : July 15, 2016
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both the PCMH and CCM, and focuses on the central role of patients in managing their illness by engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness in the real-world of primary care.

SMS is comprised of two complementary and interactive components: (1) patient engagement (e.g., the process of eliciting and responding to patients emotions and motivations related to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals, creating action plans). While several sophisticated SMS programs have been developed for T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely ignoring unique aspects of the patient context that drive and maintain health behavior. Considerable clinical research suggests that the addition of a structured, evidenced-based program of patient engagement can maximize the effectiveness of SMS programs for patients with T2DM in primary care.

To date there has been no systematic study of the degree to which fully integrating enhanced patient engagement as part of SMS will increase the initiation and maintenance of behavior change over time, and for which kinds of patients enhanced patient engagement is essential. To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program that includes a practical, time-efficient patient engagement protocol, to create a program with an integrated and comprehensive approach to SMS, called "Enhanced Engagement CTH" (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard to self-management behaviors and glycemic control in resource-limited community health centers, where vast numbers of patients with T2DM from ethnically diverse and medically vulnerable populations receive their care. The investigators will use an effectiveness-implementation hybrid design, employing the "Reach Effectiveness Adoption Implementation Maintenance" (RE-AIM) framework to test these two SMS programs for T2DM. This will provide critical information that will support dissemination and implementation of effective SMS programs in resource-limited primary care settings, serving diverse and medically vulnerable populations with much to gain from improved SMS.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Enhanced Engagement Protocol for CTH (EE-CTH) Behavioral: Connection to Health (CTH) Not Applicable

Detailed Description:

This is a two-arm, 14 month pragmatic cluster randomized trial to evaluate the added benefit of EE-CTH relative to CTH for patients with T2DM in primary care.

Primary care practices (not patients) will be randomly assigned to receive and deliver CTH or EE-CTH in an innovative effectiveness-implementation hybrid design. Using the RE-AIM framework, the investigators will evaluate program effectiveness in a real world setting, while at the same time gathering information on program reach, adoption, implementation and maintenance. CTH and EE-CTH practice trainings and delivery will each follow separate and standardized protocols, with support provided to practices through staff training, ongoing supervision and case presentations, and a practice improvement team assisted by a practice facilitator to address issues of staffing and patient flow. Practice training and facilitation notes, in conjunction with feedback from patient advisory councils, will be captured and integrated to identify barriers and facilitators to the implementation process and inform dissemination efforts. Beyond the requirements of the study, practices will be permitted to use EE-CTH or CTH with other patients as wished, which will enable the investigators to document the program's reach within the practice. Patients in both study arms will receive the intervention at a minimum of two primary care appointments (baseline and follow-up between 6 and 12 months).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 744 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Self-Management Support in Diabetes Through Patient Engagement
Actual Study Start Date : October 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Active Comparator: Connection to Health (CTH)
CTH is a comprehensive SMS program that focuses on behavior change. CTH utilizes web-based interactive behavior change technology, based on a logic model of behavior and maintenance that is informed by social-cognitive and social ecological theories. Prior to diabetes visits with a clinician, health educator, or care manager, patients complete a pre-visit CTH assessment at their practice through a tablet computer or computer kiosk. CTH assesses multiple diabetes management behaviors (diet, physical activity, medication adherence, alcohol and tobacco use, stress, mood) using brief assessment measures, each with cut-points highlighting areas of deficit. Action planning plays a central role, through a web-based platform that allows the patient and health care team to select and set goals collaboratively.
Behavioral: Connection to Health (CTH)
CTH is a comprehensive SMS program that focuses on behavior change.

Experimental: Enhanced Engagement Protocol for CTH (EE-CTH)
EE-CTH seamlessly integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol specifically designed to enhance patient engagement in SMS activities. Key components of MI have been incorporated into a practical and systematic engagement protocol that includes: (1) acknowledging the patient's point of view; (2) identifying and labeling the patient's ambivalence (both the good reasons for making the change and the good reasons for not making the change); (3) evaluating whether change is really worth the effort; (4) identifying, reflecting and labeling accompanying feelings and concerns about change; and (5) establishing a small and meaningful goal by the end of the encounter.
Behavioral: Enhanced Engagement Protocol for CTH (EE-CTH)
EE-CTH integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol.




Primary Outcome Measures :
  1. HbA1c (glycated haemoglobin) [ Time Frame: Change from baseline to follow-up (6 to 12 months) ]
    Percentage HbA1c

  2. High fat food [ Time Frame: Change from baseline to follow-up (6 to 12 months) ]
    Amount of high fat food consumed weekly adapted from the Summary of Diabetes Self-Care Activities

  3. Physical activity [ Time Frame: Change from baseline to follow-up (6 to 12 months) ]
    Number of minutes of participation in physical activity from the International Physical Activity Questionnaire

  4. Number of days missed medications [ Time Frame: Change from baseline to follow-up (6 to 12 months) ]
    Number of days missed missing one or more medications in the past 14 days

  5. Medication adherence [ Time Frame: Change from baseline to follow-up (6 to 12 months) ]
    Frequency of reasons for missing medications.

  6. Fruit and vegetable intake [ Time Frame: Change from baseline to follow-up (6 to 12 months) ]
    Number of daily fruit and vegetable servings adapted from the Summary of Diabetes Self-Care Activities

  7. Sugar-sweetened beverages [ Time Frame: Change from baseline to follow-up (6 to 12 months) ]
    Number of daily sugar-sweetened beverages from the Starting the Conversation Measure


Secondary Outcome Measures :
  1. Health-related distress [ Time Frame: Change from baseline to follow-up (6 to 12 months) ]
    Modified from the Diabetes Distress Scale

  2. Depression symptoms [ Time Frame: Change from baseline to follow-up (6 to 12 months) ]
    Patient Health Questionnaire (PHQ8) Score

  3. Weight [ Time Frame: Change from baseline to follow-up (6 to 12 months) ]
    Weight (pounds)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes;
  • Diagnosed and receiving care at participating practices for at least 12 months;
  • Able to read in English or Spanish (at least 6th grade level).

Exclusion Criteria:

  • Not meeting all inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834923


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
University of Colorado, Denver
Investigators
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Principal Investigator: Danielle M Hessler, Ph.D. University of California, San Francisco

Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02834923    
Other Study ID Numbers: 15-17033
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases