Nursing HomesNCT05193773
Effects of a Multifactorial Intervention to Reduce Physical Restraints for Care Providers in Nursing Homes
A study testing multifactorial interventions in people with Nursing Homes and Intervention, run by Su-Hua Liang at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nursing Homes, Intervention, Older People
- What is being tested?
- multifactorial interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Sep 2015to 29 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- can't speak or read chinese, Vietnamese, Indonesian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Multifactorial Intervention to Reduce Physical Restraints for Care Providers in Nursing Homes: A Cluster Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Nursing Homes, Intervention, Older People
- Being tested
- multifactorial interventions
- Keywords
- care providers, restraints
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multifactorial interventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: multifactorial interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 minutes
physical restraint use
the percentage of physical restraint use
Measured: 1 minutes
Secondary outcomes (7)
Restraint types
The percentage of restraint types use. The restraint types including device (wrist belt, waist belt, ankle belt, vest in wheel chair, belt in wheel chair, wheel chair with a table board, hand mitts, special sheet etc), area (trunk, waist, ankle, wrist), belt in bed, belt in wheel chair, day time, night, whole day.
Measured: 1 minutes
Multiple restraints
the percentage of multiple restraints
Measured: 1 minutes
agitated and inappropriate behavior
the percentage of agitated and inappropriate behavior
Measured: 1 minutes
Extubation rate
the percentage of extubation
Measured: 1 minutes
falls rate
the percentage of falls
Measured: 1 minutes
psychotropic medication prescriptions
the percentage of psychotropic medication prescriptions
Measured: 1 minutes
fall-related fractures
the percentage of fall-related fractures
Measured: 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start7 Sep 2015
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing HomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Su-Hua Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Su-Hua Liang, Chang Gung Memorial Hospital
- Investigators
- Su-Hua Liang, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193773
- Sponsor's protocol ID
- 104-5256B
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Multifactorial Intervention to Reduce Physical Restraints for Care Providers in Nursing Homes: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05193773
- Acronym / sponsor ID
- 104-5256B
- Conditions
- Nursing Homes, Intervention, Older People
- Keywords
- care providers, restraints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Su-Hua LiangUniversity, hospital or other
- Study start
- 7 Sep 2015 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comparison group | No intervention | –The Control Group received no extra care. |
| Intervention Group | Experimental | Other: multifactorial interventionsIntervention Group, Intervention with follow-up, will have a multifactorial interventions to reduce physical restraint. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- can't speak or read chinese, Vietnamese, Indonesian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multifactorial interventionsThe 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. | Other | Intervention Group |
Primary outcome
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.
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.
physical restraint use
Time frame: 1 minutes
the percentage of physical restraint use
7 secondary outcomes
Restraint types
Time frame: 1 minutes
Multiple restraints
Time frame: 1 minutes
agitated and inappropriate behavior
Time frame: 1 minutes
Extubation rate
Time frame: 1 minutes
falls rate
Time frame: 1 minutes
psychotropic medication prescriptions
Time frame: 1 minutes
fall-related fractures
Time frame: 1 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
Related trials for Nursing Homes
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
RecruitingObservational study
Physiotherapy Practice in Flemish Nursing Homes
Guideline Implementation, Physiotherapy
Not yet recruiting
Effects of Positive Psychology on Hope, Gratitude, and Well-Being
Elderly, Nursing Homes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su-Hua Liang principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multifactorial interventions in people with Nursing Homes and Intervention, run by Su-Hua Liang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge (time frame: 8 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.