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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • 朗诗常青藤养老服务有限公司睿城站
        • Contact:
          • Ping Guo

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Dementia Competence Education for care home setting
The intervention is a competency-based education program for care home staff who provide dementia care in Mainland China.
Other: Control group
Printed materials will be given to the participants in the control group for their self-study.
Other: Printed educational materials
The educational materials will be delivered to the participants in the control group for their self-study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
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.
Sense of competence in dementia care changes from baseline to immediately after intervention (2 months).
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.
Sense of competence in dementia care changes from immediately after intervention to three months after intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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.
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.
Care staff's satisfaction will be measured immediately after the intervention in intervention group.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
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.
Focus group interviews will be conducted within one week after the intervention.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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