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

May 23, 2017 updated by: Enid Kwong, The Hong Kong Polytechnic University

The Effectiveness of a Pressure Ulcer (PU) Prevention Programme for Older People in For-profit Private Nursing Homes (NHs): a Cluster Randomized Controlled Trial

This study aims to evaluate the effectiveness of a PU prevention programme for for-profit private nursing homes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1013

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Tung Wah College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
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.
Behavioral: PU prevention programme
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.
Other: control group
The control group will be provided with the usual PU prevention care
Behavioral: Usual PU prevention care
Usual PU prevention care that is a series of basic nursing care activities: repositioning of residents, moisturization , change of napkins to keep buttock dry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure ulcer incidence
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.
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).
The PUs incidence will be summed up for three periods of time, from T0 to T1, T1 to T2 and T2 to T3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Enid Kwong, PhD, Tung Wah College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2015

Primary Completion (Actual)

September 10, 2016

Study Completion (Actual)

September 10, 2016

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

October 18, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20140223001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prevention of Pressure Ulcers

Clinical Trials on PU prevention programme

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe