Clinical trial NCT00105638: Telehealth Education Program for Caregivers of Veterans With Dementia
Official title: A Telehealth Education Program for Caregivers of Veterans With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Keywords: Intervention studies
Health Care Costs
Telephone
Caregivers
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-03-17
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study was designed to evaluate the impact of a Telehealth Education Program (TEP) on outpatient veterans with moderate to severe dementia and their spouse caregivers. The TEP is a program of education, coping skills, problem solving and support presented to caregivers of veterans with dementia by teleconference in 10 weekly, one-hour sessions. The TEP was based on a stress and coping model aimed to enhance the knowledge, skills and feelings of support of the caregivers who participated.

Detailed description: Background:

This study was designed to evaluate the impact of a Telehealth Education Program (TEP) on outpatient veterans with moderate to severe dementia and their spouse caregivers. The TEP is a program of education, coping skills, problem solving and support presented to caregivers of veterans with dementia by teleconference in 10 weekly, one-hour sessions. The TEP was based on a stress and coping model aimed to enhance the knowledge, skills and feelings of support of the caregivers who participated.

Objectives:

The objectives of this study were to: 1) evaluate the impact of TEP on outpatient veterans with dementia; and 2) to help spousal caregivers gain the knowledge and skills necessary to provide the highest quality of care possible for their spouse in order to prevent unnecessary healthcare utilization and premature institutionalization. In addition, a second objective was to develop a TEP training manual for VA clinical staff and a TEP workbook for family members.

Methods:

This study employed a 2x3x2x4 randomized control group design. The design had two levels of intervention, TEP verus usual care(UC), three times of measurement (baseline, 3 months and 12 months), two sites of educational group intervention, (Albany VAMC and Buffalo VAMC) and four leaders (two nestled at each of the two sites). Veterans were included into the study if: 1) they were community dwelling; 2) had been diagnosed with Alzheimer's disease, or a related dementing disorder, and 3) scored three or higher on the Global Deterioration Scale. Caregivers were included if they: 1) were the primary care providers for the veterans, 2) had cohabitated with the veteran for more than one year, 3) reported at least a moderate level of strain, (score a seven or higher on the Caregiver Strain Index), and (4) had not participated in any other individual or group intervention program designed to support caregivers of demented persons.

There were ten TEP caregiver groups that received the educational program in one-hour sessions for 10 weeks. Demographic data were collected on the veterans and caregivers at baseline. Psychosocial outcome data were collected within two weeks prior to the intervention(baseline) and then again at three and twelve months. These were collected to evaluate whether TEP veterans would experience a reduction in behavioral problems, agitation and symptoms of depression and whether caregivers would experience a significant increase in dementia management skills, as well as, a perceived ability to care for their spouse. Outcome variables were analyzed using mixed effect regression models. Healthcare cost and utilization data were extracted from the VISTA databases and included outpatient, inpatient and nursing home data within the VA.

Status:

Completed.

Eligibility criteria: Inclusion Criteria:

* spouse of veteran
* clinical diagnosis of dementia/Alzheimers
* verbal approval from primary care provider
* living with partner

Exclusion Criteria:

* not spouse of veteran
* no clinical diagnosis of dementia
* no verbal approval from PCP
* not living with partner

Primary outcomes:
measure: Reduction in veteran agitation and symptoms of depression; increase in caregiver management skills
Secondary outcomes:
measure: Veterans will experience fewer hospitalizations and nursing home admissions
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany VA Medical Center Samuel S. Stratton, Albany, NY
state: New York
city: Buffalo
country: United States
facility: VA Western New York Healthcare System, Buffalo, NY
state: New York
Study officials:
affiliation: Albany VA Medical Center Samuel S. Stratton, Albany, NY
name: Mollie Shulan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wray LO, Shulan MD, Toseland RW, Freeman KE, Vasquez BE, Gao J. The effect of telephone support groups on costs of care for veterans with dementia. Gerontologist. 2010 Oct;50(5):623-31. doi: 10.1093/geront/gnq040. Epub 2010 May 27.