Enhancing Self-Management Support in Diabetes Through Patient Engagement

NCT02834923 | Completed

• 2 other identifiers: 15-17033R18DK108039-05
• Study Type: interventional
• Target: 725
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (7)

• HbA1c (glycated haemoglobin)

  Percentage HbA1c

  Change from baseline to follow-up (6 to 12 months)

• 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)

• 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)

• 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)

• Medication adherence

  Frequency of reasons for missing medications.

  Change from baseline to follow-up (6 to 12 months)

• 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)

• 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 Outcomes (3)

• Health-related distress

  Change from baseline to follow-up (6 to 12 months)

• Depression symptoms

  Change from baseline to follow-up (6 to 12 months)

• Weight

  Change from baseline to follow-up (6 to 12 months)

Study Arms (2)

Connection to Health (CTH)

ACTIVE COMPARATOR

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)

Enhanced Engagement Protocol for CTH (EE-CTH)

EXPERIMENTAL

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)

Interventions

Enhanced Engagement Protocol for CTH (EE-CTH) BEHAVIORAL

EE-CTH integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol.

Enhanced Engagement Protocol for CTH (EE-CTH)

Connection to Health (CTH) BEHAVIORAL

CTH is a comprehensive SMS program that focuses on behavior change.

Connection to Health (CTH)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Colorado, Denver: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (7)

• 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.

  PMID: 18752852 BACKGROUND

• 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. doi: 10.1097/00005650-198601000-00007.

  PMID: 3945130 BACKGROUND

• 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.

  PMID: 18474888 BACKGROUND

• Craig CL, Marshall AL, Sjostrom 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. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• 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. doi: 10.2337/diacare.23.7.943.

  PMID: 10895844 BACKGROUND

• 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.

  PMID: 21146770 BACKGROUND

• Hessler D, Fisher L, Dickinson M, Dickinson P, Parra J, Potter MB. The impact of enhancing self-management support for diabetes in Community Health Centers through patient engagement and relationship building: a primary care pragmatic cluster-randomized trial. Transl Behav Med. 2022 Oct 7;12(9):909-918. doi: 10.1093/tbm/ibac046.

  PMID: 36205473 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Cystathionine gamma-Lyase

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carbon-Sulfur Lyases; Lyases; Enzymes; Enzymes and Coenzymes

Study Officials

• Danielle M Hessler, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 15, 2016
• Study Start: October 1, 2016
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)