Enhancing Informal Caregiving to Support Diabetes Self-Management
2 other identifiers
interventional
864
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Dec 2012
Longer than P75 for not_applicable type-2-diabetes-mellitus
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2012
CompletedFirst Posted
Study publicly available on registry
September 13, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2017
CompletedOctober 25, 2017
October 1, 2017
4.8 years
August 22, 2012
October 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12-month glycemic control
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.
12 months
Secondary Outcomes (1)
Secondary effects upon adjustment to diabetes
12 months
Study Arms (2)
Telemonitoring + self-management support
EXPERIMENTALAutomated 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
NO INTERVENTIONUsual Care
Interventions
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
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Michigan
Ann Arbor, Michigan, 48105, United States
Hamilton Health Center
Flint, Michigan, 48504, United States
Center for Family Health
Jackson, Michigan, 49201, United States
Alcona Health Center
Lincoln, Michigan, 48742, United States
Muskegon Family Care
Muskegon Heights, Michigan, 49444, United States
St. John Masonic Medical Center
Saint Clair Shores, Michigan, 48082, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James E Aikens, PhD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Family Medicine
Study Record Dates
First Submitted
August 22, 2012
First Posted
September 13, 2012
Study Start
December 1, 2012
Primary Completion
September 26, 2017
Study Completion
September 26, 2017
Last Updated
October 25, 2017
Record last verified: 2017-10