Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00764647
Other study ID # 06-02-1779
Secondary ID
Status Completed
Phase N/A
First received October 1, 2008
Last updated July 5, 2017
Start date March 2006
Est. completion date January 2017

Study information

Verified date July 2017
Source CAMC Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date January 2017
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States West Virginia University Robert C. Byrd Health Sciences Center, Charleston Division Charleston West Virginia

Sponsors (1)

Lead Sponsor Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

Sörensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? An updated meta-analysis. Gerontologist. 2002 Jun;42(3):356-72. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Secondary 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. pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Secondary 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). pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Secondary 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. pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Secondary 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). pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Secondary 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. pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
Secondary 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. pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention
See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Recruiting NCT04038190 - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course Phase 2
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Active, not recruiting NCT05998161 - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout N/A
Completed NCT03728062 - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT06405789 - The Effect of Yoga on Mindfulness and Perceived Stress N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT05245409 - Stress, EEG, ECG, and Chiropractic N/A
Completed NCT04722367 - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT06057883 - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females Phase 2
Completed NCT05312749 - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students N/A
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Completed NCT05623826 - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager N/A
Completed NCT04013451 - The Kiss of Kindness Study II N/A