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The Effectiveness of a Pressure Ulcer Prevention Programme for Older People in For-profit Private Nursing Homes

Primary Purpose

Prevention of Pressure Ulcers

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PU prevention programme
Usual PU prevention care
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Pressure Ulcers focused on measuring pressure ulcer, nursing home

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria :

  • For-profit private nursing homes having been classified as the category A2 homes in the Enhanced Bought Place Scheme and are eager to improve current pressure ulcer prevention care;
  • For for-profit private nursing homes having a capacity of around 130-150 beds;
  • For for-profit private nursing homes having no structured PU prevention protocol, and/or programmes in place;- Residents aged 60 or above
  • Care staff including personal care workers, health workers and nurses who provide direct care to residents.

Exclusion Criteria:

  • Care staffs who are not speak in Chinese.

Sites / Locations

  • Tung Wah College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

control group

Arm Description

The experimental group will be implemented a 16-week PU prevention programme. The PU prevention programme includes an intensive training on knowledge and skills ono PU prevention and also a PU prevention protocol. The purpose of the programme is to equip care staff with PU knowledge and skills and to guide especially health workers and personal care workers in PU prevention.

The control group will be provided with the usual PU prevention care

Outcomes

Primary Outcome Measures

Pressure ulcer incidence
The two RAs will inspect the skin of each residents three times a week to detect the first PUs ( those detected on residents without PUs) and the new PUs (those detected on residents already suffering from PUs), starting from one day before the staff training to the end of the protocol implementation (. The numbers, locations, and stages of the PUs detected will be recorded in the PU incidence form. The PU incidence will be then summed up for three periods of time as following. T0 to T1: one day before the commencement of the training course (T0) to the day immediately before the commencement of the protocol implementation (T1) .T1 to T2: the day immediately before the commencement of the protocol implementation (T1) to the eighth week after the commencement of the protocol implementation (T2).T2 to T3: the eighth week after the commencement of the protocol implementation (T2) to the sixteenth week of protocol implementation (T3).

Secondary Outcome Measures

Full Information

First Posted
September 16, 2014
Last Updated
May 23, 2017
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02270385
Brief Title
The Effectiveness of a Pressure Ulcer Prevention Programme for Older People in For-profit Private Nursing Homes
Official Title
The Effectiveness of a Pressure Ulcer (PU) Prevention Programme for Older People in For-profit Private Nursing Homes (NHs): a Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2, 2015 (Actual)
Primary Completion Date
September 10, 2016 (Actual)
Study Completion Date
September 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to evaluate the effectiveness of a PU prevention programme for for-profit private nursing homes
Detailed Description
The study will be conducted as a two-arm cluster randomized controlled trial, which will compare the efficacy of a PU prevention programme versus usual PU prevention for older people in eight for-profit private nursing homes in Hong Kong. For-profit private NHs recruited will be randomly assigned as experimental or control groups. The nursing homes in the experimental group will be implemented a PU prevention programme. The programme includes a training course which was tailor-made for health workers(HWs) and persona care workers (PCWs) and also a 16-week PU prevention protocol. The outcome measures are incidence and prevalence rate of PUs as well as level of PU knowledge and skill among care staff in the nursing homes. In data analysis, survival analysis will be adopted for identifying PU incidence and prevalence rate. GEE will be used to analyze the time and effect differences of PU knowledge and skills among the care staff between two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Pressure Ulcers
Keywords
pressure ulcer, nursing home

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1013 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The experimental group will be implemented a 16-week PU prevention programme. The PU prevention programme includes an intensive training on knowledge and skills ono PU prevention and also a PU prevention protocol. The purpose of the programme is to equip care staff with PU knowledge and skills and to guide especially health workers and personal care workers in PU prevention.
Arm Title
control group
Arm Type
Other
Arm Description
The control group will be provided with the usual PU prevention care
Intervention Type
Behavioral
Intervention Name(s)
PU prevention programme
Intervention Description
The PU prevention programme consists of two major components which are an intensive training course(a 2-hour lecture and two skill training sessions) and a PU prevention protocol.
Intervention Type
Behavioral
Intervention Name(s)
Usual PU prevention care
Intervention Description
Usual PU prevention care that is a series of basic nursing care activities: repositioning of residents, moisturization , change of napkins to keep buttock dry.
Primary Outcome Measure Information:
Title
Pressure ulcer incidence
Description
The two RAs will inspect the skin of each residents three times a week to detect the first PUs ( those detected on residents without PUs) and the new PUs (those detected on residents already suffering from PUs), starting from one day before the staff training to the end of the protocol implementation (. The numbers, locations, and stages of the PUs detected will be recorded in the PU incidence form. The PU incidence will be then summed up for three periods of time as following. T0 to T1: one day before the commencement of the training course (T0) to the day immediately before the commencement of the protocol implementation (T1) .T1 to T2: the day immediately before the commencement of the protocol implementation (T1) to the eighth week after the commencement of the protocol implementation (T2).T2 to T3: the eighth week after the commencement of the protocol implementation (T2) to the sixteenth week of protocol implementation (T3).
Time Frame
The PUs incidence will be summed up for three periods of time, from T0 to T1, T1 to T2 and T2 to T3.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria : For-profit private nursing homes having been classified as the category A2 homes in the Enhanced Bought Place Scheme and are eager to improve current pressure ulcer prevention care; For for-profit private nursing homes having a capacity of around 130-150 beds; For for-profit private nursing homes having no structured PU prevention protocol, and/or programmes in place;- Residents aged 60 or above Care staff including personal care workers, health workers and nurses who provide direct care to residents. Exclusion Criteria: Care staffs who are not speak in Chinese.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enid Kwong, PhD
Organizational Affiliation
Tung Wah College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tung Wah College
City
Hong Kong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32285486
Citation
Kwong EW, Chen LY, Kwan RY, Lee PH. The effectiveness of a pressure injury prevention program for nursing assistants in private for-profit nursing homes: A cluster randomized controlled trial. J Adv Nurs. 2020 Jul;76(7):1780-1793. doi: 10.1111/jan.14391. Epub 2020 May 11.
Results Reference
derived
PubMed Identifier
26782677
Citation
Kwong EW, Lee PH, Yeung KM. Study protocol of a cluster randomized controlled trial evaluating the efficacy of a comprehensive pressure ulcer prevention programme for private for-profit nursing homes. BMC Geriatr. 2016 Jan 18;16:20. doi: 10.1186/s12877-016-0189-2.
Results Reference
derived

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The Effectiveness of a Pressure Ulcer Prevention Programme for Older People in For-profit Private Nursing Homes

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