NCT00764647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

5.5 years

First QC Date

October 1, 2008

Last Update Submit

July 5, 2017

Conditions

Keywords

family caregiverscaregiver educationcaregiver burdencaregiver hardinesscaregiver depressive symptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Knowledge of Caregiving (change over time)

    pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention

  • Quality of Life (change over time)

    pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention

  • Physical and Mental Health (change over time)

    pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention

  • Depressive Symptomatology (change over time)

    pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention

  • Caregiver Burden (change over time)

    pre-intervention, immediate post-intervention, six-month post-intervention, and twelve-month post intervention

  • +1 more secondary outcomes

Study Arms (1)

Single arm

EXPERIMENTAL

Education program for family caregivers of frail elders.

Behavioral: Education program for family caregivers of frail elders

Interventions

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.

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • family member participating in care of a frail elder (60 years and older)

You may not qualify if:

  • unable to speak or read English (materials are written in English)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University Robert C. Byrd Health Sciences Center, Charleston Division

Charleston, West Virginia, 25304, United States

Location

Related Publications (3)

  • 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.

    PMID: 12040138BACKGROUND
  • 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.

    PMID: 11490046BACKGROUND
  • 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.

    PMID: 11746065BACKGROUND

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Barbara L Nunley, PhD, RN

    West Virginia University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Faculty Emerita, West Virginia University School of Nursing.

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 2, 2008

Study Start

March 1, 2006

Primary Completion

September 1, 2011

Study Completion

January 1, 2017

Last Updated

July 7, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations