StressNCT00764647
Education Program for Family Caregivers
A study testing Education program for family caregivers of frail elders in people with Stress, run by CAMC Health System at 1 site in United States.
Trial summary
The purpose of this evaluation was to determine the effectiveness of an educational program designed to assist family caregivers to learn the knowledge and skills to take better care of their frail elder relatives and themselves. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Education program for family caregivers of frail elders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jan 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- family member participating in care of a frail elder (60 years and older)
Who cannot join
- unable to speak or read English (materials are written in English)
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Robert C. Byrd Health Sciences Center, Charleston Division
Charleston, West Virginia, 25304
About this study
Official title: Evaluation of Education Program for Family Caregivers of Frail Elders
The purpose of this evaluation was to determine the effectiveness of an educational program designed to assist family caregivers to learn the knowledge and skills to take better care of their frail elder relatives and themselves.
Read the detailed description
Spouses, children, and other family members typically care for frail elderly persons. These family caregivers attempt to provide care for their relative in the home, despite the potential for excessive stress to themselves. This care may extend over many years, involving unrelenting management of their relative, which puts the caregiver at risk for the development of physical and mental health consequences. The stress of caring for a frail elder may result in the institutionalization of the care receiver due to declining health or abilities in the caregiver as caregivers frequently continue to provide care at the expense of their own health. The goal of the education program is to fill an important need, that is, assist caregivers to become empowered, hardier, and have the ability to cope with the stress associated with caregiving. The aim is to investigate whether this educational intervention improves selected outcomes for family caregivers of frail elders. The selected outcomes are knowledge of caregiving, hardiness, quality of life, physical health, depressive symptoms, burden, and coping.
- Conditions
- Stress
- Being tested
- Education program for family caregivers of frail elders
- Keywords
- family caregivers, caregiver education, caregiver burden, caregiver hardiness, caregiver depressive symptoms
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education program for family caregivers of frail eldersBehavioural
Family caregiver participants in the educational program will receive an educational course presented by the investigator that focuses on the care of the frail elder and themselves. The course will involve four to five consecutive weekly sessions, each 2 1/2 to 3 hours long. The educational program will be offered biannually, spring and fall seasons.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Education program for family caregivers of frail elders. Receives: Behavioral: Education program for family caregivers of frail elders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hardiness (change over time)
Hardiness was measured using the Psychological Hardiness Scale, a 40 item scale (Younkin \& Betz, 1996). Responses for each item were obtained on a 5-point Likert continuum from "Strongly Disagree" (1) to Strongly Agree (5).
Measured: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Secondary outcomes (6)
Knowledge of Caregiving (change over time)
Knowledge about caregiving was operationalized by total score on a content-specific test (17 items) for the family caregivers' educational program that measured knowledge and behaviors. True/false answers were given to items.
Measured: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Quality of Life (change over time)
Quality of life measured using a Cantril (1965) ladder scale. The participants viewed a picture of a ladder with nine rungs, with the top rung labeled "best possible life" (9) and the bottom rung labeled "worst possible life (0).
Measured: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Physical and Mental Health (change over time)
The SF-36v2 Health Survey (Ware \& Sherboume, 1992), a 36-item self-report scale was used to measure the caregiver's view of their health.
Measured: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Depressive Symptomatology (change over time)
The Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977), a 20 item self report scale, was used to measure depressive symptomatology. Participants rated how frequently each symptom occurred during the past week on a scale ranging from rarely or none of the time (0) to most or all of the time (3).
Measured: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Caregiver Burden (change over time)
The Caregiver Burden Inventory (CBI), developed by Novak and Guest (1989), a 24-item multidimensional measure was used to measure caregiver burden. This inventory includes five factors: Time-dependence burden, Developmental burden, physical burden, Social burden, and Emotional burden.
Measured: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Coping (change over time)
The Jalowiec Coping Scale (JCS) (Jalowiec, Murphy, \& Powers, 1984) was used to measure coping mechanisms. There are 60 items classified into 8 different coping styles: confrontive, evasive, optimistic, fatalistic, emotive, palliative, supportant, and self-reliant.
Measured: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startMar 2006
- Primary completionSep 2011
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara L Nunley, PhD, RN, Principal investigator, West Virginia University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764647
- Sponsor's protocol ID
- 06-02-1779
- Status last verified
- Jul 2017
- First submitted
- 1 Oct 2008
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sorensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? An updated meta-analysis. Gerontologist. 2002 Jun;42(3):356-72. doi: 10.1093/geront/42.3.356.
PubMed 12040138Burgio L, Lichstein KL, Nichols L, Czaja S, Gallagher-Thompson D, Bourgeois M, Stevens A, Ory M, Schulz R; REACH Investigators. Judging outcomes in psychosocial interventions for dementia caregivers: the problem of treatment implementation. Gerontologist. 2001 Aug;41(4):481-9. doi: 10.1093/geront/41.4.481.
PubMed 11490046Acton GJ, Kang J. Interventions to reduce the burden of caregiving for an adult with dementia: a meta-analysis. Res Nurs Health. 2001 Oct;24(5):349-60. doi: 10.1002/nur.1036.
PubMed 11746065
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Education Program for Family Caregivers of Frail Elders
- ClinicalTrials.gov ID
- NCT00764647
- Acronym / sponsor ID
- 06-02-1779
- Conditions
- Stress
- Keywords
- family caregivers, caregiver education, caregiver burden, caregiver hardiness, caregiver depressive symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- Mar 2006 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Oct 2008 (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.
The purpose of this evaluation was to determine the effectiveness of an educational program designed to assist family caregivers to learn the knowledge and skills to take better care of their frail elder relatives and themselves.
Detailed description
Spouses, children, and other family members typically care for frail elderly persons. These family caregivers attempt to provide care for their relative in the home, despite the potential for excessive stress to themselves. This care may extend over many years, involving unrelenting management of their relative, which puts the caregiver at risk for the development of physical and mental health consequences. The stress of caring for a frail elder may result in the institutionalization of the care receiver due to declining health or abilities in the caregiver as caregivers frequently continue to provide care at the expense of their own health. The goal of the education program is to fill an important need, that is, assist caregivers to become empowered, hardier, and have the ability to cope with the stress associated with caregiving. The aim is to investigate whether this educational intervention improves selected outcomes for family caregivers of frail elders. The selected outcomes are knowledge of caregiving, hardiness, quality of life, physical health, depressive symptoms, burden, and coping.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Behavioral: Education program for family caregivers of frail eldersEducation program for family caregivers of frail elders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age and older
- family member participating in care of a frail elder (60 years and older)
Key exclusion criteria (1 listed)
- unable to speak or read English (materials are written in English)
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 |
|---|---|---|
| Education program for family caregivers of frail eldersFamily caregiver participants in the educational program will receive an educational course presented by the investigator that focuses on the care of the frail elder and themselves. The course will involve four to five consecutive weekly sessions, each 2 1/2 to 3 hours long. The educational program will be offered biannually, spring and fall seasons. | Behavioural | Single arm |
Primary outcome
Hardiness (change over time)
Time frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Hardiness was measured using the Psychological Hardiness Scale, a 40 item scale (Younkin \& Betz, 1996). Responses for each item were obtained on a 5-point Likert continuum from "Strongly Disagree" (1) to Strongly Agree (5).
6 secondary outcomes
Knowledge of Caregiving (change over time)
Time frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Quality of Life (change over time)
Time frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Physical and Mental Health (change over time)
Time frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Depressive Symptomatology (change over time)
Time frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Caregiver Burden (change over time)
Time frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Coping (change over time)
Time frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
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 18 Aug 2026.
- Background: PubMed 12040138Sorensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? An updated meta-analysis. Gerontologist. 2002 Jun;42(3):356-72. doi: 10.1093/geront/42.3.356.
- Background: PubMed 11490046Burgio L, Lichstein KL, Nichols L, Czaja S, Gallagher-Thompson D, Bourgeois M, Stevens A, Ory M, Schulz R; REACH Investigators. Judging outcomes in psychosocial interventions for dementia caregivers: the problem of treatment implementation. Gerontologist. 2001 Aug;41(4):481-9. doi: 10.1093/geront/41.4.481.
- Background: PubMed 11746065Acton GJ, Kang J. Interventions to reduce the burden of caregiving for an adult with dementia: a meta-analysis. Res Nurs Health. 2001 Oct;24(5):349-60. doi: 10.1002/nur.1036.
- Individual participant dataSharing planned: No
Related trials for Stress
Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
Recruiting
DBT-P Treatment Study
Emotion Dysregulation
RecruitingObservational study
Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
Cardiovascular (CV) Risk
Not yet recruiting
RISE for PTSD and Substance Use Disorder in Veterans
Stress Disorders, Post-Traumatic, Substance-Related Disorders
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.
Barbara L Nunley, PhD, RN principal investigator
West Virginia University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education program for family caregivers of frail elders in people with Stress, run by CAMC Health System at 1 site 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 2 inclusion and 1 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Hardiness (change over time) (time frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention). 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 NCT00764647, which also lists 3 linked publications.
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 18 Aug 2026.