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Enhancing Informal Caregiving to Support Diabetes Self-Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684709
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : October 25, 2017
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Aikens, PhD, University of Michigan

Brief Summary:
This study compares the medical and psychological effects of telemonitoring plus intensified self-management support to those of usual care alone for patients with poorly controlled type 2 diabetes mellitus (DM). If this intervention proves effective without increasing costs or clinician burden, then its implementation could yield major public health benefits, especially for vulnerable and underserved DM patients, and broader societal benefit may occur through increased helping behavior and strengthened social ties.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Telemonitoring + self-management support Not Applicable

Detailed Description:
Although in-home caregivers (ICGs) help improve diabetes mellitus (DM) outcomes, they may lack the resources needed to do this optimally, and are at risk for psychosocial decline and caregiver burnout. Complicating matters, millions of chronically-ill older Americans live alone and receive long-distance caregiving without any supporting structure or resources to ensure its effectiveness. In this study, diabetes patients with poor glycemic will be recruited from two clinical sites, and half will have an ICG. Patients will nominate a "CarePartner" (CP; adult relatives or friends from outside their home) to receive weekly email reports about their DM health and behavioral needs, and will be given resources to help them to provide self-management support. Patients will then be randomized to receive either one year of CP intervention or usual medical care. In the CP intervention arm, patients will provide weekly updates on their DM health and self-management through weekly automated telemonitoring. Summaries of this will be emailed to their CP along with guidance on helping the patient address reported problem(s), and their clinicians will be alerted about medically-urgent problems. We will assess the following outcomes in both arms before intervention and also after 6 and 12 months of intervention: glycemic control, DM-related distress, DM self-management, health-related quality of life, systolic blood pressure, caregiver burden, relationship quality, and cost of DM care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 864 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing Informal Caregiving to Support Diabetes Self-Management
Study Start Date : December 2012
Actual Primary Completion Date : September 26, 2017
Actual Study Completion Date : September 26, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telemonitoring + self-management support
Automated assessment calls with follow-up by a Care Manager and a CarePartner for 12 months. Baseline, 6 month, and 12 month follow-up.
Behavioral: Telemonitoring + self-management support
Weekly automated assessment calls with follow-up by a care manager and a CarePartner for 12 months. Baseline, 6 month, and 12 month follow-up

No Intervention: Usual Care
Usual Care

Primary Outcome Measures :
  1. 12-month glycemic control [ Time Frame: 12 months ]
    H1 (Primary biological outcome): Compared to DM patients randomized to control, those randomized to intervention will have a 0.3% greater improvement in HbA1c units.

Secondary Outcome Measures :
  1. Secondary effects upon adjustment to diabetes [ Time Frame: 12 months ]
    Compared to controls, intervention patients will have lower diabetes related distress.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • type 2 DM (hospitalization or outpatient visit within 12 months for >2 ICD9 codes of 250.xx or therapeutic class codes C4G, C4K, or C4L in past 2 years' problem list)
  • poor glycemic control (recent HbA1c% >7.5)
  • at least 21 years old
  • fluent in English
  • can use telephone numeric touchtone keypad
  • can identify 1-4 eligible CPs
  • not in palliative care, on transplant waitlist, or at high risk for 1-year mortality
  • free of major psychiatric or cognitive impairment.
  • ICGs: We will stratify recruitment within sites so that 50% of enrolled patients have an ICG.
  • Patients with an ICG cannot enroll unless their ICG also provides consent.
  • has a CP that resides in continental US but outside patient's household; has communicated with patient, in person or by phone, at least once monthly over preceding 6 months; has a home telephone or mobile cell phone; has an internet connection; can communicate via e-mail; is free of severe psychiatric/cognitive impairment; is fluent in English; and is at least 21 years of age.

Exclusion criteria

  • Limited life expectancy (e.g., advanced stage cancer/heart failure/on oxygen/end stage renal disease), receiving palliative care
  • active alcohol or drug abuse
  • dementia, bipolar disorder, schizophrenia
  • unable to speak English
  • not planning to get all or most of care at study site
  • primary care physician not affiliated with study site
  • unable to use a telephone to respond to weekly automated self-management support calls
  • unable to nominate an eligible CP
  • ICG (if present) does not consent to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01684709

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
Hamilton Health Center
Flint, Michigan, United States, 48504
Center for Family Health
Jackson, Michigan, United States, 49201
Alcona Health Center
Lincoln, Michigan, United States, 48742
Muskegon Family Care
Muskegon Heights, Michigan, United States, 49444
St. John Masonic Medical Center
Saint Clair Shores, Michigan, United States, 48082
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: James E Aikens, PhD University of Michigan

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Responsible Party: James Aikens, PhD, Associate Professor of Family Medicine, University of Michigan Identifier: NCT01684709    
Other Study ID Numbers: DK088294
1R18DK088294-01 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Pending IRB approval.
Keywords provided by James Aikens, PhD, University of Michigan:
Type 2 Diabetes
Informal Caregivers
Self Care
Quality of Life
Health Information Technology
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases