Telehealth Education Program for Caregivers of Veterans With Dementia

Alzheimer Disease Clinical Trial

Official title:

A Telehealth Education Program for Caregivers of Veterans With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105638
• Other study ID #: IIR 03-076
• Status: Completed
• Phase: N/A
• First received: March 16, 2005
• Last updated: April 6, 2015
• Start date: September 2005
• Est. completion date: April 2007

Study information

• Verified date: November 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• educational program, by telephone

Locations

Country	Name	City	State
United States	Albany VA Medical Center Samuel S. Stratton, Albany, NY	Albany	New York
United States	VA Western New York Healthcare System, Buffalo, NY	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wray LO, Shulan MD, Toseland RW, Freeman KE, Vásquez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in veteran agitation and symptoms of depression; increase in caregiver management skills			No
Secondary	Veterans will experience fewer hospitalizations and nursing home admissions			No