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Clinical Trials/NCT05193773
NCT05193773CompletedNot Applicable

The Effects of a Multifactorial Intervention to Reduce Physical Restraints for Care Providers in Nursing Homes: A Cluster Randomized Controlled Trial

Su-Hua Liang1 site in 1 country354 target enrollmentStarted: September 7, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
354
Locations
1
Primary Endpoint
knowledge

Study Overview

Brief Summary

Scholars from around the world have been strongly advocating restraint-free care in long-term care institutions. Therefore, the aim of this study was to evaluate the effects of a multifactorial intervention to reduce physical restraints for care providers in nursing homes.

Detailed Description

In Taiwanese nursing homes, the use of physical restraints on residents as a protective measure is fairly common. However, physical restraints can be seen as a violation of human rights, and there is no guarantee of the effectiveness or safety of such physical restraints.This study was to evaluate the effects of a multifactorial intervention to reduce physical restraints for care providers in nursing homes. A cluster randomized controlled trial was conducted using pretest-posttest control group design. A purposive sampling of participants was chosen from care providers of 6 nursing home institutions in Taiwan, who were then randomly assigned to the experimental group (3 nursing homes) or the control group (3 nursing homes). The experimental group underwent multifactorial interventions to reduce physical restraint.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • A full-time care provider
  • Worked in a nursing home for more than three months
  • Care providers have imposed physical restraints on elderly residents aged 60 or above Within the last month.

Exclusion Criteria

  • can't speak or read chinese, Vietnamese, Indonesian

Outcomes

Primary Outcomes

knowledge

Time Frame: 8 minutes

The Knowledge of Restraints use scale . The Knowledge of Restraints use scale was used to assess the knowledge component. The scale consists of 20 items scored as 1 (true) or 0 (false or uncertainty). A higher score indicates more knowledge; total scores range from 0 to 20.

physical restraint use

Time Frame: 1 minutes

the percentage of physical restraint use

Attitudes

Time Frame: 8 minutes

The Attitudes of Restraints use scale . The Attitudes of Restraints use scale was used to assess participants' attitudes about restraint use. The scale is a 15 items with a 5-point Likert scale ranging from 1 (not at all agree) to 5 (most agree); the range of total scores is from 15 to 75. Higher scores indicate more negative attitudes about physical restraint use.

Behavior

Time Frame: 4 minutes

The Behavior of restraints use scale . The Behavior of restraints use scale was used to assess care providers' behavior about restraint use. The scale consists of 13 items scored as 1 (yes) or 0 (no); the range of total scores is from 0 to 13. The higher the score, the better the behavior.

Secondary Outcomes

  • agitated and inappropriate behavior(1 minutes)
  • Extubation rate(1 minutes)
  • fall-related fractures(1 minutes)
  • Restraint types(1 minutes)
  • Multiple restraints(1 minutes)
  • psychotropic medication prescriptions(1 minutes)
  • falls rate(1 minutes)

Investigators

Sponsor
Su-Hua Liang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Su-Hua Liang

Investigator

Chang Gung Memorial Hospital

Study Sites (1)

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