Enhancing Self-Management Support in Diabetes Through Patient Engagement

Diabetes Mellitus, Type 2 Clinical Trial

— EE-CTH  

Official title:

Enhancing Self-Management Support in Diabetes Through Patient Engagement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834923
• Other study ID #: 15-17033
• Secondary ID: R18DK108039-05
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 20, 2020

Study information

• Verified date: February 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 725
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Enhanced Engagement Protocol for CTH (EE-CTH)
EE-CTH integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol.
• Connection to Health (CTH)
CTH is a comprehensive SMS program that focuses on behavior change.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (6)

Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. — View Citation

Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842. — View Citation

Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27. — View Citation

Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. — View Citation

Paxton AE, Strycker LA, Toobert DJ, Ammerman AS, Glasgow RE. Starting the conversation performance of a brief dietary assessment and intervention tool for health professionals. Am J Prev Med. 2011 Jan;40(1):67-71. doi: 10.1016/j.amepre.2010.10.009. — View Citation

Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c (glycated haemoglobin)	Percentage HbA1c	Change from baseline to follow-up (6 to 12 months)
Primary	High fat food	Amount of high fat food consumed weekly adapted from the Summary of Diabetes Self-Care Activities	Change from baseline to follow-up (6 to 12 months)
Primary	Physical activity	Number of minutes of participation in physical activity from the International Physical Activity Questionnaire	Change from baseline to follow-up (6 to 12 months)
Primary	Number of days missed medications	Number of days missed missing one or more medications in the past 14 days	Change from baseline to follow-up (6 to 12 months)
Primary	Medication adherence	Frequency of reasons for missing medications.	Change from baseline to follow-up (6 to 12 months)
Primary	Fruit and vegetable intake	Number of daily fruit and vegetable servings adapted from the Summary of Diabetes Self-Care Activities	Change from baseline to follow-up (6 to 12 months)
Primary	Sugar-sweetened beverages	Number of daily sugar-sweetened beverages from the Starting the Conversation Measure	Change from baseline to follow-up (6 to 12 months)
Secondary	Health-related distress	Modified from the Diabetes Distress Scale	Change from baseline to follow-up (6 to 12 months)
Secondary	Depression symptoms	Patient Health Questionnaire (PHQ8) Score	Change from baseline to follow-up (6 to 12 months)
Secondary	Weight	Weight (pounds)	Change from baseline to follow-up (6 to 12 months)