Enhancing Informal Caregiving to Support Diabetes Self-Management

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Telemonitoring + self-management support

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.

• Study Type: Interventional
• Enrollment (Actual): 864
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan
    • Flint, Michigan, United States, 48504
      • Hamilton Health Center
    • Jackson, Michigan, United States, 49201
      • Center for Family Health
    • Lincoln, Michigan, United States, 48742
      • Alcona Health Center
    • Muskegon Heights, Michigan, United States, 49444
      • Muskegon Family Care
    • Saint Clair Shores, Michigan, United States, 48082
      • St. John Masonic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
No Intervention: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary effects upon adjustment to diabetes	Compared to controls, intervention patients will have lower diabetes related distress.	12 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: James E Aikens, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 26, 2017
• Study Completion (Actual): September 26, 2017

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: September 10, 2012
• First Posted (Estimate): September 13, 2012

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Quality of Life; Type 2 Diabetes; Health Information Technology; Self Care; Informal Caregivers
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DK088294; 1R18DK088294-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Pending IRB approval.