NCT03717077

Brief Summary

This study aimed to test the effects of a learned resourcefulness interveniton program on the learned resourcefulness, caregiver burden, quality of life for older family caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 6, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

October 22, 2018

Last Update Submit

January 27, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Self-control as the learned resourcefulness measured by Rosenbaum's self control schedule

    which is a 36-item scale, is used to measure the cognitive and problem-solving skills, the higher the score, the better a self-control of a person

    9 weeks

  • Caregiver burden measured by caregiver burden scale

    which is a 20-item scale by Lee and Wu, The total score ranges between 0 and 60, with a higher score representing a higher degree of burden.

    9 weeks

  • Quality of life measured by EuroQol five dimension scale (ED-5Q)

    The EuroQol five dimension scale (ED-5Q) developed by the EuroQol Group, the higher the score, the better the state of health.

    9 weeks

Study Arms (2)

Learned resourcefulness intervention

EXPERIMENTAL

The learned resourcefulness program includes: 1) Solving problem strategy, 2) Organizing daily actions, 3) Using self-regulation, 4) Reframing positive situations, 5) Changing negative self-thinking, 6) Exploring new thinking and skills. It is conducted one time per week.

Procedure: learned resourcefulness intervention

Usual home care service

NO INTERVENTION

The control group maintains home care service

Interventions

The LR program includes: 1) Solving problem strategy, 2) Organizing daily actions, 3) Using self-regulation, 4) Reframing positive situations, 5) Changing negative self-thinking, 6) Exploring new thinking and skills. It is conducted one time per week.

Learned resourcefulness intervention

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 60 and above
  • family caregivers of disabled adults who received home care service
  • cognitively intact as assessed by SPMSQ score of 8 and above
  • disabled adults will assessed by Barthel Index score of 60 and bellow
  • able to answer questions

You may not qualify if:

  • participants with severe mental disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meng-Chun Chen (MCC)

Chiayi City, 61363, Taiwan

Location

MeSH Terms

Conditions

Self-ControlCaregiver Burden

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorStress, PsychologicalBehavioral Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

January 6, 2019

Primary Completion

April 1, 2019

Study Completion

April 12, 2019

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations