Enhancing Informal Caregiving to Support Diabetes Self-Management

Completed · Not applicable

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01684709

Run by

University of Michigan

People needed

864

Starts

2012-12-01

Expected to finish

2017-09-26

Last updated by the study team

2017-10-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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