Enhancing Informal Caregiving to Support Diabetes Self-Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Aikens, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01684709
First received: August 22, 2012
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Behavioral: Telemonitoring + self-management support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancing Informal Caregiving to Support Diabetes Self-Management

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 12-month glycemic control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Secondary effects upon adjustment to diabetes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compared to controls, intervention patients will have lower diabetes related distress.


Estimated Enrollment: 890
Study Start Date: December 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01684709

Contacts
Contact: Gina VanderVeen, MPH grvander@umich.edu

Locations
United States, Michigan
Alcona Health Center Recruiting
Alpena, Michigan, United States, 49707
Contact: Tom Marshall, MD         
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Principal Investigator: James E Aikens, PhD         
Center for Family Health Recruiting
Jackson, Michigan, United States, 49201
Contact: Gregory Naylor, MD         
Alcona Health Center Recruiting
Lincoln, Michigan, United States, 48742
Contact: Tom Marshall, MD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: James E Aikens, PhD University of Michigan
  More Information

No publications provided

Responsible Party: James Aikens, PhD, Associate Professor of Family Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT01684709     History of Changes
Other Study ID Numbers: DK088294, 1R18DK088294-01
Study First Received: August 22, 2012
Last Updated: September 20, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Michigan:
Type 2 Diabetes
Informal Caregivers
Self Care
Quality of Life
Health Information Technology

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

ClinicalTrials.gov processed this record on August 28, 2014