DementiaNCT00105638
Telehealth Education Program for Caregivers of Veterans With Dementia
A study testing educational program, by telephone in people with Dementia and Alzheimer Disease, run by US Department of Veterans Affairs at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- educational program, by telephone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2005to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- spouse of veteran
- clinical diagnosis of dementia/Alzheimers
- verbal approval from primary care provider
- living with partner
Who cannot join
- not spouse of veteran
- no clinical diagnosis of dementia
- no verbal approval from PCP
- not living with partner
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Albany VA Medical Center Samuel S. Stratton, Albany, NY
Albany, New York, 12208
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215
About this study
Official title: A Telehealth Education Program for Caregivers of Veterans With Dementia
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.
Read the 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.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- educational program, by telephone
- Keywords
- Intervention studies, Health Care Costs, Telephone, Caregivers
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational program, by telephoneBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: educational program, by telephone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in veteran agitation and symptoms of depression; increase in caregiver management skills
Secondary outcomes (1)
Veterans will experience fewer hospitalizations and nursing home admissions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2005 (estimated)
- Study startSep 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mollie Shulan, MD, Principal investigator, Albany VA Medical Center Samuel S. Stratton, Albany, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105638
- Sponsor's protocol ID
- IIR 03-076
- Status last verified
- Nov 2007
- First submitted
- 16 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20507926
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telehealth Education Program for Caregivers of Veterans With Dementia
- ClinicalTrials.gov ID
- NCT00105638
- Acronym / sponsor ID
- IIR 03-076
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- Intervention studies, Health Care Costs, Telephone, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 17 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: educational program, by telephone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- spouse of veteran
- clinical diagnosis of dementia/Alzheimers
- verbal approval from primary care provider
- living with partner
Key exclusion criteria (4 listed)
- not spouse of veteran
- no clinical diagnosis of dementia
- no verbal approval from PCP
- not living with partner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational program, by telephone | Behavioural | Arm 1 |
Primary outcome
Reduction in veteran agitation and symptoms of depression; increase in caregiver management skills
1 secondary outcome
Veterans will experience fewer hospitalizations and nursing home admissions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 20507926Wray 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mollie Shulan, MD principal investigator
Albany VA Medical Center Samuel S. Stratton, Albany, NY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational program, by telephone in people with Dementia and Alzheimer Disease, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in veteran agitation and symptoms of depression; increase in caregiver management skills. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.