Frail ElderlyPhase 2NCT00012779
Effectiveness of a Health Education Program in a Primary Care Setting
A Phase 2 study testing Health Education Program in people with Frail Elderly, run by US Department of Veterans Affairs at 3 sites in United States.
Trial summary
This study was designed to assess the effectiveness of a Health Education Program (HEP) for improving the well-being and reducing the health care use and cost of care of frail older outpatient veterans, and for improving the well-being of their spouse caregivers. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Health Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento Mar 2003
- Phase
- Phase 2
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregiver inclusion criteria: 2) married to, and living with, the care recipient; 2) age 55 and older; 3) being the primary care provider for the care recipient and reporting at least a moderate level of burden on the Caregiver Strain Index; 4) report spouse has poor health care; and 5) receiver age 55 and suffering from chronic health condition.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Albany VA Medical Center Samuel S. Stratton, Albany, NY
Albany, New York, 12208
VA Boston Healthcare System Brockton Campus, Brockton, MA
Brockton, Massachusetts, 02301
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215
About this study
This study was designed to assess the effectiveness of a Health Education Program (HEP) for improving the well-being and reducing the health care use and cost of care of frail older outpatient veterans, and for improving the well-being of their spouse caregivers. HEP is a multi-component group program delivered in 8 weekly, 2-hour sessions, and 10 monthly 2-hour follow-up sessions, it includes emotion-focused and problem focused coping strategies, education and support.
Read the detailed description
Background:
This study was designed to assess the effectiveness of a Health Education Program (HEP) for improving the well-being and reducing the health care use and cost of care of frail older outpatient veterans, and for improving the well-being of their spouse caregivers. HEP is a multi-component group program delivered in 8 weekly, 2-hour sessions, and 10 monthly 2-hour follow-up sessions, it includes emotion-focused and problem focused coping strategies, education and support.
Objectives:
The objectives of this study are to evaluate: 1) effects of HEP on the perceived health status, emotional well-being, and social support of frail veterans; 2) effects of HEP on the perceived health, emotional well-being, social support, burden levels, self-appraisal of change, pressing problems associated with caregiving, knowledge and use of community resources by caregiver; and 3) effects of HEP on the health care use and costs of care recipients.
Methods:
HEP was evaluated using a randomized control group design. The design has two levels of intervention, HEP vs. Usual Care (UC), 3 VA medical centers (VAMCs), and 4 times of measurement (at baseline, after the 8th HEP meeting, and at 1 and 2 years after baseline). Data reported here are for 8 week and 1-year psychosocial outcomes and 18 months for VA cost. Caregivers and veterans (n = 466) were randomized in 3 VAMCs, 114 to UC and 119 to HEP. The typical caregiver was 68 years old, married, white, female, with some college education and living with the veteran. The typical veteran care recipient was 74 years old, white, male with some college education, and suffered from one or more chronic health problems. Fifteen HEP groups were conducted. Caregivers and recipients were assessed on: 1) health and functional status; 2) emotional well-being; and 3) social support. In addition, caregivers were assessed for change in coping skills, change in burden level, pressing problems, and knowledge and use of community resources. Data was analyzed using random effects regression models.
Status:
Data on two-year outcomes for health and functional status, emotional well-being, and social support of caregivers and veterans, problems associated with caregiving and Medicare plus VA costs are being collected and analyzed for an amended final report.
- Conditions
- Frail Elderly
- Being tested
- Health Education Program
- Keywords
- Health Care Education, Health Care Cost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Education ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Health Education Program |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joseph B. Engelhardt, PhD, Principal investigator, Albany VA Medical Center Samuel S. Stratton, Albany, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012779
- Sponsor's protocol ID
- IIR 95-118
- Status last verified
- Jun 2005
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Effectiveness of a Health Education Program in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT00012779
- Acronym / sponsor ID
- IIR 95-118
- Conditions
- Frail Elderly
- Keywords
- Health Care Education, Health Care Cost
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Mar 2003 (actual)
- First posted
- 16 Mar 2001 (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 assess the effectiveness of a Health Education Program (HEP) for improving the well-being and reducing the health care use and cost of care of frail older outpatient veterans, and for improving the well-being of their spouse caregivers. HEP is a multi-component group program delivered in 8 weekly, 2-hour sessions, and 10 monthly 2-hour follow-up sessions, it includes emotion-focused and problem focused coping strategies, education and support.
Detailed description
Background:
This study was designed to assess the effectiveness of a Health Education Program (HEP) for improving the well-being and reducing the health care use and cost of care of frail older outpatient veterans, and for improving the well-being of their spouse caregivers. HEP is a multi-component group program delivered in 8 weekly, 2-hour sessions, and 10 monthly 2-hour follow-up sessions, it includes emotion-focused and problem focused coping strategies, education and support.
Objectives:
The objectives of this study are to evaluate: 1) effects of HEP on the perceived health status, emotional well-being, and social support of frail veterans; 2) effects of HEP on the perceived health, emotional well-being, social support, burden levels, self-appraisal of change, pressing problems associated with caregiving, knowledge and use of community resources by caregiver; and 3) effects of HEP on the health care use and costs of care recipients.
Methods:
HEP was evaluated using a randomized control group design. The design has two levels of intervention, HEP vs. Usual Care (UC), 3 VA medical centers (VAMCs), and 4 times of measurement (at baseline, after the 8th HEP meeting, and at 1 and 2 years after baseline). Data reported here are for 8 week and 1-year psychosocial outcomes and 18 months for VA cost. Caregivers and veterans (n = 466) were randomized in 3 VAMCs, 114 to UC and 119 to HEP. The typical caregiver was 68 years old, married, white, female, with some college education and living with the veteran. The typical veteran care recipient was 74 years old, white, male with some college education, and suffered from one or more chronic health problems. Fifteen HEP groups were conducted. Caregivers and recipients were assessed on: 1) health and functional status; 2) emotional well-being; and 3) social support. In addition, caregivers were assessed for change in coping skills, change in burden level, pressing problems, and knowledge and use of community resources. Data was analyzed using random effects regression models.
Status:
Data on two-year outcomes for health and functional status, emotional well-being, and social support of caregivers and veterans, problems associated with caregiving and Medicare plus VA costs are being collected and analyzed for an amended final report.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Health Education Program |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Caregiver inclusion criteria: 2) married to, and living with, the care recipient; 2) age 55 and older; 3) being the primary care provider for the care recipient and reporting at least a moderate level of burden on the Caregiver Strain Index; 4) report spouse has poor health care; and 5) receiver age 55 and suffering from chronic health condition.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Health Education Program | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
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.
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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.
Joseph B. Engelhardt, PhD principal investigator
Albany VA Medical Center Samuel S. Stratton, Albany, NY
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Health Education Program in people with Frail Elderly, run by US Department of Veterans Affairs at 3 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 1 inclusion and 0 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 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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.