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Telehealth Education Program for Caregivers of Veterans With Dementia

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ClinicalTrials.gov Identifier: NCT00105638
Recruitment Status : Completed
First Posted : March 17, 2005
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Behavioral: educational program, by telephone Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Telehealth Education Program for Caregivers of Veterans With Dementia
Study Start Date : September 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arms and Interventions
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Arm Intervention/treatment
Arm 1 Behavioral: educational program, by telephone


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in veteran agitation and symptoms of depression; increase in caregiver management skills

Secondary Outcome Measures :
  1. Veterans will experience fewer hospitalizations and nursing home admissions

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105638


Locations
United States, New York
Albany VA Medical Center Samuel S. Stratton, Albany, NY
Albany, New York, United States, 12208
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, United States, 14215
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Mollie Shulan, MD Albany VA Medical Center Samuel S. Stratton, Albany, NY
More Information
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Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00105638     History of Changes
Other Study ID Numbers: IIR 03-076
First Posted: March 17, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: November 2007

Keywords provided by VA Office of Research and Development:
Intervention studies
Health Care Costs
Telephone
Caregivers

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders