Enhancing Informal Caregiving to Support Diabetes Self-Management

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Telemonitoring + self-management support

• Registration Number: NCT01684709
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-13
• Study Start: 2012-12
• Primary Completion: 2017-09-26
• Study Completion: 2017-09-26
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 864

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring + self-management support	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.

Primary Outcome Measures

Name	Time	Method
12-month glycemic control	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

Name	Time	Method
Secondary effects upon adjustment to diabetes	12 months	Compared to controls, intervention patients will have lower diabetes related distress.

Trial Locations

Locations (6)

Hamilton Health Center; 🇺🇸 Flint, Michigan, United States

Center for Family Health; 🇺🇸 Jackson, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Alcona Health Center; 🇺🇸 Lincoln, Michigan, United States

St. John Masonic Medical Center; 🇺🇸 Saint Clair Shores, Michigan, United States

Muskegon Family Care; 🇺🇸 Muskegon Heights, Michigan, United States