- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00764647
Education Program for Family Caregivers
July 5, 2017 updated by: Barbara Nunley, PhD, CAMC Health System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Virginia
-
Charleston, West Virginia, United States, 25304
- West Virginia University Robert C. Byrd Health Sciences Center, Charleston Division
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age and older
- family member participating in care of a frail elder (60 years and older)
Exclusion Criteria:
- unable to speak or read English (materials are written in English)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm
Education program for family caregivers of frail elders.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge of Caregiving (change over time)
Time Frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
|
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.
|
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
|
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).
|
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
|
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.
|
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
|
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).
|
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
|
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.
|
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
|
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.
|
pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barbara L Nunley, PhD, RN, West Virginia University School of Nursing
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Burgio 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.
- Acton 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2006
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
October 1, 2008
First Submitted That Met QC Criteria
October 1, 2008
First Posted (Estimate)
October 2, 2008
Study Record Updates
Last Update Posted (Actual)
July 7, 2017
Last Update Submitted That Met QC Criteria
July 5, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 06-02-1779
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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