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

Primary Purpose

Diabetes Complications, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Telephone Counseling
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Complications focused on measuring motivational interviewing, telephone counseling, medical education, diabetes self management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

Telephone Counseling

Arm Description

Participants will receive standard care from physicians for monitoring and treating their diabetes. They are placed on a wait list to receive the intervention.

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.

Outcomes

Primary Outcome Measures

Change in hemoglobin A1c
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
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.

Full Information

First Posted
September 24, 2012
Last Updated
November 19, 2014
Sponsor
Northwestern University
Collaborators
Diabetes Action Research and Education Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01695278
Brief Title
A Pilot Intervention Study of Health Coaching to Promote Diabetes Self-Care in the Community
Acronym
C4C
Official Title
Coaching for Control: A Pilot Intervention Study of Health Coaching to Promote Diabetes Self-Care in the Community
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Diabetes Action Research and Education Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications, Diabetes Mellitus, Type 2
Keywords
motivational interviewing, telephone counseling, medical education, diabetes self management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Participants will receive standard care from physicians for monitoring and treating their diabetes. They are placed on a wait list to receive the intervention.
Arm Title
Telephone Counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Task related self-efficacy for initiating and maintaining diabetes self-management
Description
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.
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Diabetes self-management behaviors
Description
To describe differences in diabetes self-management behavior in participants in the intervention as compared with the wait list control arm
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercedes R Carnethon, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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

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