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Education Program for Family Caregivers

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ClinicalTrials.gov Identifier: NCT00764647
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Barbara Nunley, PhD, CAMC Health System

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date July 7, 2017
Actual Study Start Date  ICMJE March 2006
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
hardiness [ Time Frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
  • 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.
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
knowledge of caregiving, quality of life, physical health, depressive symptoms, burden, and coping [ Time Frame: pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Education Program for Family Caregivers
Official Title  ICMJE Evaluation of Education Program for Family Caregivers of Frail Elders
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stress
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Single arm
Education program for family caregivers of frail elders.
Intervention: Behavioral: Education program for family caregivers of frail elders
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2011)
42
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
50
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764647
Other Study ID Numbers  ICMJE 06-02-1779
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barbara Nunley, PhD, CAMC Health System
Study Sponsor  ICMJE CAMC Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara L Nunley, PhD, RN West Virginia University School of Nursing
PRS Account CAMC Health System
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP