- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04445077
Education Program for Care Home Staff
June 23, 2020 updated by: Yayi ZHAO, Chinese University of Hong Kong
Effects of a Competency-based Education Program on Care Home Staff's Sense of Competence Related to Dementia Care in Mainland China: A Mixed-methods Approach
The competence of care home staff in dementia care is highly influential to the quality of care that adversely affects both people living with dementia and staff and in Mainland China where knowledge on dementia among care home staff was generally poor and this area is under-researched.
This study aims at developing a competency-based culturally-sensitive education program on dementia care for care home staff through literature review, qualitative study.
And then a quasi-experiment design without random assignment will be conducted to evaluate the effects of this program on care home staff's sense of competence, knowledge, attitudes, and care approach related to dementia care and staff satisfaction with the intervention.
Focus group interviews will be conducted to understand participants' experience about the education program after the intervention.
This study is expected to provide an effective way to improve care homes staff's competence in dementia care thereby improve the quality of care.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
144
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 Contact
- Name: Yayi ZHAO
- Phone Number: (852)54263094
- Email: zhaoyayi@link.cuhk.edu.hk
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Recruiting
- 朗诗常青藤养老服务有限公司睿城站
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Contact:
- Ping Guo
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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
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Care homes:
- having at least 10 people with dementia living in;
- with at least 10 care staff working for people with dementia;
- which do not have any educational activities for staff in dementia three months before the study and staff training plan during the whole study period;
- whose management level agrees to participate.
Care staff:
- working for people with dementia;
- speaking and reading Chinese;
- being willing to participate in the study.
Exclusion Criteria:
- having any educational activities in dementia three months before the study;
- having a training plan during the whole study period.
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: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
The education will be delivered weekly with 60-90 minutes per lecture for eight lectures.
Multiple teaching methods will be used, including lectures, structured handouts, video, role play, case study and discussion.
During the study period, the research team will provide ongoing support and consultation through electronic communication and bimonthly field visits.
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The intervention is a competency-based education program for care home staff who provide dementia care in Mainland China.
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Other: Control group
Printed materials will be given to the participants in the control group for their self-study.
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The educational materials will be delivered to the participants in the control group for their self-study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of sense of competence in dementia care
Time Frame: Sense of competence in dementia care changes from baseline to immediately after intervention (2 months).
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Sense of competence in dementia care will be measured by Sense of Competence in dementia care scale.The total score is 17-68 by adding up the score of each item.
Higher scores mean higher level of sense of confidence.
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Sense of competence in dementia care changes from baseline to immediately after intervention (2 months).
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Change of Sense of competence in dementia care
Time Frame: Sense of competence in dementia care changes from immediately after intervention to three months after intervention.
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Sense of competence in dementia care will be measured by Sense of Competence in dementia care scale.The total score is 17-68 by adding up the score of each item.
Higher scores mean higher level of sense of confidence.
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Sense of competence in dementia care changes from immediately after intervention to three months after intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of knowledge on dementia
Time Frame: Knowledge on dementia changes from baseline to immediately after intervention (2 months).
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Knowledge on dementia will be assessed by using Dementia Knowledge Assessment Scale.
The total score is 0 to 50 by adding up the scores of all items.
Higher score means better knowledge on dementia.
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Knowledge on dementia changes from baseline to immediately after intervention (2 months).
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Change of knowledge on dementia
Time Frame: Knowledge on dementia changes from immediately after intervention to three months after intervention.
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Knowledge on dementia will be assessed by using Dementia Knowledge Assessment Scale.
The total score is 0 to 50 by adding up the scores of all items.
Higher score means better knowledge on dementia.
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Knowledge on dementia changes from immediately after intervention to three months after intervention.
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Change of attitude towards dementia care
Time Frame: Attitude towards dementia care changes from baseline to immediately after intervention (2 months).
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Attitude towards dementia care will be assessed by using Approaches to Dementia Questionnaire.
The total score is 19-95 with higher score indicating the more positive attitudes.
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Attitude towards dementia care changes from baseline to immediately after intervention (2 months).
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Change of attitude towards dementia care
Time Frame: Attitude towards dementia care changes from immediately after intervention to three months after intervention.
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Attitude towards dementia care will be assessed by using Approaches to Dementia Questionnaire.
The total score is 19-95 with higher score indicating the more positive attitudes.
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Attitude towards dementia care changes from immediately after intervention to three months after intervention.
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Change of person-centred care approach
Time Frame: Person-centred care approach changes from baseline to immediately after intervention (2 months).
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Person-centred care approach will be assessed by Person-centred care assessment tools.
The total score ranges from 15 to 75 with higher score indicating higher degree of person-centred care provision in the institutions.
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Person-centred care approach changes from baseline to immediately after intervention (2 months).
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Change of person-centred care approach
Time Frame: Person-centred care approach changes from immediately after intervention to three months after intervention.
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Person-centred care approach will be assessed by Person-centred care assessment tools.
The total score ranges from 15 to 75 with higher score indicating higher degree of person-centred care provision in the institutions.
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Person-centred care approach changes from immediately after intervention to three months after intervention.
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Change of severity of behavioural and psychological symptoms of dementia (BPSD) of residents with dementia
Time Frame: Severity of BPSD of residents with dementia changes from baseline to immediately after intervention (2 months).
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Severity of BPSD of residents with dementia will be assessed by Neuropsychiatric Inventory - Nursing Home Version (NPI-NH).
The frequency × severity of each item yielded a composite symptom, and total severity scores which ranges from 1 to 36 reflecting the sum of each item score.
Higher scores indicate more severe symptoms.
The total score of caregiver distress range from 12 to 60, with higher score indicating more severe distress.
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Severity of BPSD of residents with dementia changes from baseline to immediately after intervention (2 months).
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Change of severity of behavioural and psychological symptoms of dementia (BPSD) of residents with dementia
Time Frame: Severity of BPSD of residents with dementia changes from immediately after intervention to three months after intervention.
|
Severity of BPSD of residents with dementia will be assessed by Neuropsychiatric Inventory - Nursing Home Version (NPI-NH).
The frequency × severity of each item yielded a composite symptom, and total severity scores which ranges from 1 to 36 reflecting the sum of each item score.
Higher scores indicate more severe symptoms.
The total score of caregiver distress range from 12 to 60, with higher score indicating more severe distress.
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Severity of BPSD of residents with dementia changes from immediately after intervention to three months after intervention.
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Care staff's satisfaction
Time Frame: Care staff's satisfaction will be measured immediately after the intervention in intervention group.
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Care staff's satisfaction will be measured with a self-developed, five-point Likert, five-item scale including satisfaction with educational content, teaching form, provider, usefulness and overall evaluation.
The total score ranges from 5 to 25, with higher score representing more dissatisfaction on the training.
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Care staff's satisfaction will be measured immediately after the intervention in intervention group.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants' experience about the intervention
Time Frame: Focus group interviews will be conducted within one week after the intervention.
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Focus group interviews which will last around 40-60 minutes will be conducted to understand care home staff's experience and their perceptions towards the program.
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Focus group interviews will be conducted within one week after the intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
June 1, 2020
Primary Completion (Anticipated)
October 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
June 21, 2020
First Submitted That Met QC Criteria
June 23, 2020
First Posted (Actual)
June 24, 2020
Study Record Updates
Last Update Posted (Actual)
June 24, 2020
Last Update Submitted That Met QC Criteria
June 23, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.
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