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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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ClinicalTrials.gov Identifier: NCT02270385
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Enid Kwong, The Hong Kong Polytechnic University

Study Description
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Brief Summary:
This study aims to evaluate the effectiveness of a PU prevention programme for for-profit private nursing homes

Condition or disease Intervention/treatment Phase
Prevention of Pressure Ulcers Behavioral: PU prevention programme Behavioral: Usual PU prevention care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1013 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 2, 2015
Actual Primary Completion Date : September 10, 2016
Actual Study Completion Date : September 10, 2016

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Arms and Interventions
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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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270385


Locations
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China
Tung Wah College
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Enid Kwong, PhD Tung Wah College
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Enid Kwong, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02270385    
Other Study ID Numbers: HSEARS20140223001
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enid Kwong, The Hong Kong Polytechnic University:
pressure ulcer
nursing home
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases