Telehealth Education Program for Caregivers of Veterans With Dementia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105638
First received: March 16, 2005
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Dementia
Alzheimer Disease
Behavioral: educational program, by telephone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Telehealth Education Program for Caregivers of Veterans With Dementia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Reduction in veteran agitation and symptoms of depression; increase in caregiver management skills [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Veterans will experience fewer hospitalizations and nursing home admissions [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: September 2005
Study Completion Date: April 2007
Arms Assigned Interventions
Arm 1 Behavioral: educational program, by telephone

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105638

Locations
United States, New York
Albany VA Medical Center: Samuel S. Stratton
Albany, New York, United States, 12208
VISN 2 Center for Integrated Healthcare, Buffalo
Buffalo, New York, United States, 14215
Sponsors and Collaborators
Investigators
Principal Investigator: Mollie Shulan, MD Albany VA Medical Center: Samuel S. Stratton
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00105638     History of Changes
Other Study ID Numbers: IIR 03-076
Study First Received: March 16, 2005
Last Updated: April 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Intervention studies
Health Care Costs
Telephone
Caregivers

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 20, 2014