DementiaNCT04445077
Education Program for Care Home Staff
A study testing Dementia Competence Education for care home setting and Printed educational materials in people with Dementia, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Dementia Competence Education for care home setting and Printed educational materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- Jun 2020to Dec 2020
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- working for people with dementia;
- speaking and reading Chinese;
- being willing to participate in the study.
Who cannot join
- having any educational activities in dementia three months before the study;
- having a training plan during the whole study period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
朗诗常青藤养老服务有限公司睿城站
Nanjing, Jiangsu, 210029
Ping Guo
About this study
Official title: 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.
- Conditions
- Dementia
- Being tested
- Dementia Competence Education for care home setting, Printed educational materials
- Keywords
- dementia, long-term care, competency, education, staff
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia Competence Education for care home settingOther
The intervention is a competency-based education program for care home staff who provide dementia care in Mainland China.
Printed educational materialsOther
The educational materials will be delivered to the participants in the control group for their self-study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Dementia Competence Education for care home setting |
| Control group | Other | Printed materials will be given to the participants in the control group for their self-study. Receives: Other: Printed educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of sense of competence in dementia care
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.
Measured: Sense of competence in dementia care changes from baseline to immediately after intervention (2 months).
Change of Sense of competence in dementia care
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.
Measured: Sense of competence in dementia care changes from immediately after intervention to three months after intervention.
Secondary outcomes (9)
Change of knowledge on dementia
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.
Measured: Knowledge on dementia changes from baseline to immediately after intervention (2 months).
Change of knowledge on dementia
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.
Measured: Knowledge on dementia changes from immediately after intervention to three months after intervention.
Change of attitude towards dementia care
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.
Measured: Attitude towards dementia care changes from baseline to immediately after intervention (2 months).
Change of attitude towards dementia care
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.
Measured: Attitude towards dementia care changes from immediately after intervention to three months after intervention.
Change of person-centred care approach
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.
Measured: Person-centred care approach changes from baseline to immediately after intervention (2 months).
Change of person-centred care approach
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.
Measured: Person-centred care approach changes from immediately after intervention to three months after intervention.
Change of severity of behavioural and psychological symptoms of dementia (BPSD) of residents with dementia
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.
Measured: Severity of BPSD of residents with dementia changes from baseline to immediately after intervention (2 months).
Change of severity of behavioural and psychological symptoms of dementia (BPSD) of residents with dementia
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.
Measured: Severity of BPSD of residents with dementia changes from immediately after intervention to three months after intervention.
Care staff's satisfaction
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.
Measured: Care staff's satisfaction will be measured immediately after the intervention in intervention group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yayi ZHAO, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445077
- Sponsor's protocol ID
- 2019.500
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04445077
- Acronym / sponsor ID
- 2019.500
- Conditions
- Dementia
- Keywords
- dementia, long-term care, competency, education, staff
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Jun 2020 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Dementia Competence Education for care home settingThe 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. |
| Control group | Other | Other: Printed educational materialsPrinted materials will be given to the participants in the control group for their self-study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- working for people with dementia;
Key exclusion criteria (2 listed)
- having any educational activities in dementia three months before the study;
- having a training plan during the whole study period.
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 |
|---|---|---|
| Dementia Competence Education for care home settingThe intervention is a competency-based education program for care home staff who provide dementia care in Mainland China. | Other | Intervention group |
| Printed educational materialsThe educational materials will be delivered to the participants in the control group for their self-study. | Other | Control group |
Primary outcome
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).
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.
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.
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.
9 secondary outcomes
Change of knowledge on dementia
Time frame: Knowledge on dementia changes from baseline to immediately after intervention (2 months).
Change of knowledge on dementia
Time frame: Knowledge on dementia changes from immediately after intervention to three months after intervention.
Change of attitude towards dementia care
Time frame: Attitude towards dementia care changes from baseline to immediately after intervention (2 months).
Change of attitude towards dementia care
Time frame: Attitude towards dementia care changes from immediately after intervention to three months after intervention.
Change of person-centred care approach
Time frame: Person-centred care approach changes from baseline to immediately after intervention (2 months).
Change of person-centred care approach
Time frame: Person-centred care approach changes from immediately after intervention to three months after intervention.
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).
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.
Care staff's satisfaction
Time frame: Care staff's satisfaction will be measured immediately after the intervention in intervention group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Competence Education for care home setting and Printed educational materials in people with Dementia, run by Chinese University of Hong Kong at 1 site in China.
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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jun 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yayi ZHAO ((852)54263094, zhaoyayi@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 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 24 Jun 2020.