Telehealth Education Program for Caregivers of Veterans With Dementia
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00105638 |
|
Recruitment Status :
Completed
First Posted : March 17, 2005
Last Update Posted : April 7, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dementia Alzheimer Disease | Behavioral: educational program, by telephone | Not Applicable |
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 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 |
| Arm | Intervention/treatment |
|---|---|
| Arm 1 |
Behavioral: educational program, by telephone |
- Reduction in veteran agitation and symptoms of depression; increase in caregiver management skills
- Veterans will experience fewer hospitalizations and nursing home admissions
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, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| 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 | |
| Principal Investigator: | Mollie Shulan, MD | Albany VA Medical Center Samuel S. Stratton, Albany, NY |
Publications of Results:
| Responsible Party: | US Department of Veterans Affairs |
| 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 |
|
Intervention studies Health Care Costs Telephone Caregivers |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |