NCT05193773

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
354

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 7, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2016

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

January 5, 2022

Last Update Submit

January 14, 2022

Conditions

Keywords

care providersrestraints

Outcome Measures

Primary Outcomes (4)

  • knowledge

    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.

    8 minutes

  • Attitudes

    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.

    8 minutes

  • Behavior

    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.

    4 minutes

  • physical restraint use

    the percentage of physical restraint use

    1 minutes

Secondary Outcomes (7)

  • Restraint types

    1 minutes

  • Multiple restraints

    1 minutes

  • agitated and inappropriate behavior

    1 minutes

  • Extubation rate

    1 minutes

  • falls rate

    1 minutes

  • +2 more secondary outcomes

Study Arms (2)

comparison group

NO INTERVENTION

The Control Group received no extra care.

Intervention Group

EXPERIMENTAL

Intervention Group, Intervention with follow-up, will have a multifactorial interventions to reduce physical restraint.

Other: multifactorial interventions

Interventions

The experimental group underwent multifactorial interventions to reduce physical restraint, including developing routines for physical restraint, promoting institutional policies to reduce the use of physical restraint, developing alternative methods, education, and consultations.

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing Homes

Miaoli, Taiwan

Location

Study Officials

  • Su-Hua Liang

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 18, 2022

Study Start

September 7, 2015

Primary Completion

February 29, 2016

Study Completion

February 29, 2016

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations