A Pilot Intervention Study of Health Coaching to Promote Diabetes Self-Care in the Community (C4C)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Northwestern University
Sponsor:
Collaborator:
Diabetes Action Research and Education Foundation
Information provided by (Responsible Party):
Mercedes Carnethon, Northwestern University
ClinicalTrials.gov Identifier:
NCT01695278
First received: September 24, 2012
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

Diabetes poses a substantial burden to racial/ethnic minorities and in populations with limited access to healthcare. However, there is a shortage of healthcare providers available to help patients adopt the lifestyle changes required for diabetes control. The goal of the present study is to evaluate the feasibility and effectiveness of a diabetes self-care intervention delivered by medical students to patients with poorly controlled diabetes. Training medical students to use proven communication techniques to help patients identify and overcome barriers to adopting lifestyle changes in diabetes is a novel but plausible strategy. The investigators anticipate that findings from our pilot study will be used to develop a larger study to definitively test the program's effectiveness. A long-term benefit of our program is that future healthcare providers are practicing the skills needed to promote positive lifestyle changes and provide care for chronic conditions in diverse communities.


Condition Intervention Phase
Diabetes Complications
Diabetes Mellitus, Type 2
Behavioral: Telephone Counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Coaching for Control: A Pilot Intervention Study of Health Coaching to Promote Diabetes Self-Care in the Community

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in hemoglobin A1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Changes in hemoglobin A1c between baseline and the end of follow-up will be compared between participants in the intervention arm vs. the control arm.


Secondary Outcome Measures:
  • Task related self-efficacy for initiating and maintaining diabetes self-management [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Determine whether diabetes patients in the intervention arm report higher task-related self-efficacy for initiating and maintaining recommended diabetes self-care behaviors than participants in the wait list control arm.


Other Outcome Measures:
  • Diabetes self-management behaviors [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    To describe differences in diabetes self-management behavior in participants in the intervention as compared with the wait list control arm


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care
Participants will receive standard care from physicians for monitoring and treating their diabetes. They are placed on a wait list to receive the intervention.
Behavioral: Telephone Counseling
Weekly telephone counseling intervention for 16 weeks, used to identify and overcome barriers to diabetes control and set goals for positive behavioral changes supplemented by monthly group classes on skill development.
Experimental: Telephone Counseling
Weekly telephone counseling intervention for 16 weeks, used to identify and overcome barriers to diabetes control and set goals for positive behavioral changes supplemented by monthly group classes on skill development.
Behavioral: Telephone Counseling
Weekly telephone counseling intervention for 16 weeks, used to identify and overcome barriers to diabetes control and set goals for positive behavioral changes supplemented by monthly group classes on skill development.

Detailed Description:

Diabetes and its complications pose a substantial physical, psychological and financial burden on the large number of racial/ethnic minorities and other socioeconomically deprived persons with diabetes. However, self-management goals are often not met in racial/ethnic minorities and in populations with fewer socioeconomic resources. In response, our research team has developed a novel "health coaching" intervention to promote diabetes self-management in the community. Health coaching is based on Control Systems Theory and helps patients to: 1) identify problems in self-care behaviors; 2) create dynamic plans for correcting these issues; and, 3) learn to navigate the complexities of everyday life and to achieve clinically and personally desirable outcomes. The primary innovation of the present project is that first-year medical students are trained to serve as the health coaches, and are participating in the study Coaching for Control (STU00069506). The objective of our pilot study is to test whether 20 patients from five Northwestern Medicine primary care practice groups (two in the Austin community, two at Northwestern Memorial Hospital and one at Norwegian American Hospital) enrolled in the "Coaching for Control" intervention experience favorable changes in clinical and behavioral outcomes after 16 weeks as compared with an equal number of patients from those same clinics who are not enrolled in the program. We will use a non-randomized trial design to carry out the following aims: 1. Determine whether patients with diabetes who participate in the "Coaching for Control" behavioral intervention program (i.e., the intervention arm) have lower hemoglobin A1c (HbA1c) after four months than patients who do not participate in the program (i.e., the control arm). 2. Determine whether diabetes patients in the intervention arm report higher task-related self-efficacy for initiating and maintaining recommended diabetes self-care behaviors than participants in the control arm. We hypothesize that participants in the intervention arm will have more favorable HbA1c and report higher self-efficacy for diabetes self-care behaviors than participants in the control arm. Secondary objectives are to test whether these changes persist 8 months after the program ends and to test whether we observe changes in additional clinical measures such as blood pressure, waist circumference, and in self-reported health behaviors such as medication adherence, self-care behaviors, physical activity and diet. Process evaluations through focus groups and interviews with participants will allow us to refine our intervention. The translational aspects of our proposal include the application of a proven intervention to promote diabetes self-care in a community setting that includes adults at high risk for diabetes complications. Findings from the present pilot study will be used to justify expansion of the study to a larger group of community members so that we can carry out a larger randomized trial of efficacy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18 years old,
  • diagnosis of diabetes
  • ability to read and understand English,
  • access to a personal telephone,
  • intent to remain in the medical practice group for at least 1 year,
  • intention to remain in the Chicago, IL area or surrounding suburbs for 1 year.
  • Ability to read and understand the informed consent.

Exclusion Criteria:

  • primary diagnosis of gestational diabetes or type 1 diabetes
  • severe mental impairment,
  • primary preferred language other than English
  • severe comorbidity with a life expectancy of < 1 year
  • currently enrolled in another counseling-based diabetes intervention program
  • prior participation in the Coaching for Control intervention development in 2012
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695278

Contacts
Contact: Mercedes R Carnethon, PhD 312-503-4479 carnethon@northwestern.edu
Contact: Peter John D De Chavez, MS 312-503-5512 p-chavez@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Mercedes R Carnethon, PhD    312-503-4479    carnethon@northwestern.edu   
Contact: Sylvia Badon, MS    (312) 503-4749    s-badon@northwestern.edu   
Principal Investigator: Mercedes R Carnethon, Ph.D.         
Sub-Investigator: Linda Ehrlich-Jones, Ph.D.         
Sub-Investigator: Mark Loafman, MD         
Sub-Investigator: Mary A. Friedman, BS         
Sub-Investigator: Peter John D De Chavez, MS         
Sponsors and Collaborators
Northwestern University
Diabetes Action Research and Education Foundation
Investigators
Principal Investigator: Mercedes R Carnethon, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Mercedes Carnethon, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01695278     History of Changes
Other Study ID Numbers: STU00068025
Study First Received: September 24, 2012
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
motivational interviewing
telephone counseling
medical education
diabetes self management

Additional relevant MeSH terms:
Diabetes Complications
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 28, 2014