Enhancing Informal Caregiving to Support Diabetes Self-Management



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:10/27/2017
Start Date:December 2012
End Date:September 26, 2017

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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.

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.

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.
We found this trial at
6
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: James E Aikens, PhD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Flint, Michigan 48504
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Jackson, Michigan 49201
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Jackson, MI
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Lincoln, Michigan 48742
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Lincoln, MI
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Muskegon Heights, Michigan 49444
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Muskegon Heights, MI
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21099 Masonic Boulevard
Saint Clair Shores, Michigan 48082
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Saint Clair Shores, MI
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