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Diabetes ComplicationsPhase 3C4CNCT01695278

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

A Phase 3 study testing Telephone Counseling in people with Diabetes Complications and Diabetes Mellitus, Type 2, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telephone Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Sep 2012to Aug 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Coaching for Control: A Pilot Intervention Study of Health Coaching to Promote Diabetes Self-Care in the Community

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.

Read the 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.

Being tested
Telephone Counseling
Keywords
motivational interviewing, telephone counseling, medical education, diabetes self management
Medical subject headings
Diabetes Complications, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telephone CounselingBehavioural

    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.

Study groups in NCT01695278
Study groupRoleWhat they receive
Standard CareActive comparatorParticipants will receive standard care from physicians for monitoring and treating their diabetes. They are placed on a wait list to receive the intervention.
Receives: Behavioral: Telephone Counseling
Telephone CounselingExperimentalWeekly 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.
Receives: Behavioral: Telephone Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 16 weeks

Secondary outcomes (1)
  1. 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.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJan 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01695278
Sponsor's protocol ID
STU00068025
Acronym
C4C
Status last verified
Nov 2014
First submitted
24 Sep 2012
Last updated
21 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telephone Counseling in people with Diabetes Complications and Diabetes Mellitus, Type 2, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hemoglobin A1c (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.

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