Enhancing Informal Caregiving to Support Diabetes Self-Management

NCT ID: NCT01684709

Last Updated: 2017-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 864 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2017-09-26

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes; Informal Caregivers; Self Care; Quality of Life; Health Information Technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telemonitoring + self-management support

Intervention Type: BEHAVIORAL

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

Usual Care

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

James Aikens, PhD

Associate Professor of Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James E Aikens, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Hamilton Health Center

Flint, Michigan, United States

Center for Family Health

Jackson, Michigan, United States

Alcona Health Center

Lincoln, Michigan, United States

Muskegon Family Care

Muskegon Heights, Michigan, United States

St. John Masonic Medical Center

Saint Clair Shores, Michigan, United States

Countries

United States

Other Identifiers

1R18DK088294-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK088294

Identifier Type: -

Identifier Source: org_study_id