Education Program for Family Caregivers

August 17, 2026 updated by: 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single arm
Education program for family caregivers of frail elders.
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CAMC Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2008

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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