DementiaNCT04845789
Case Manager Approach in Dementia Care From a Caregiver Perspective
An observational study of Dementia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a qualitative study to explore opinions of family caregivers of community-dwelling people with dementia on case manager approach in dementia care. Semi-structured interviews will be used for data collection. Purposive sampling was used to recruit caregivers from Jockey Club Centre for Positive Ageing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Non-interventional
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 May 2021to 31 Jul 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Family caregivers of person with dementia
Who may be able to join
- care recipients having clinical diagnosis of dementia of any stage
- participants being the family caregivers of care recipients, providing care for at least 10 hours per week
- caregivers receiving case manager support for at least 3 months
Who cannot join
- caregivers who were under age of 18 and those exhibiting intellectual impairment
- caregivers who were not immediate family members of care recipients
- caregivers who could not communicate in Cantonese or English
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Jockey Club Centre for Positive Ageing
Shatin, NT, 0000
Andrew Cheung, Mr, +85253456773, info@jccpa.org.hk
About this study
Official title: Case Manager Approach in Dementia Care From a Caregiver Perspective: A Grounded Theory Study
This is a qualitative study to explore opinions of family caregivers of community-dwelling people with dementia on case manager approach in dementia care. Semi-structured interviews will be used for data collection. Purposive sampling was used to recruit caregivers from Jockey Club Centre for Positive Ageing. Grounded Theory would be used for data analysis.
Read the detailed description
This was a qualitative study using semi-structured interviews with caregivers of community-dwelling people with dementia. Purposive sampling was used to recruit caregivers from Jockey Club Centre for Positive Ageing.
Study protocol would be explained by principal investigator (PI) to case managers in JCCPA, including aim and objectives of the study, inclusion criteria, exclusion criteria and interview questions.
Due to privacy issues, case managers in JCCPA would screen family caregivers and ask for consent to participate in the study. Contact method of caregivers would be provided to PI by JCCPA case managers upon caregivers' consent. PI would then approach caregivers to arrange online meetings and send the online consent form to them for their consideration and reference. Risks and benefits of the study and the right to withdraw from the study at any time would be explained to participants before consent form was signed by participants digitally.
Demographic data such as age, gender, education level, years of caregiving to PWD and time spent on caregiving would be collected using Google form.
All interviews were conducted through video-conferencing individually. Each interview took 30 to 45 minutes. The interviews were started with an close-ended question, such as "Do you know the special approach that JCCPA has adopted?" and "Did the staff tell you about it at admission?", followed up by open-ended questions such as "What do you know about case management?" and "Can you tell me how your caregiving experience was with case manager support?". Subsequent probing questions aimed at clarification and gaining more insight on their experience, was guided by the participant's responses.
Demographic data such as age, gender, education level, years of caregiving to PWD and time spent on caregiving would be collected using Google form.
All interviews were conducted through video-conferencing individually. Each interview took 30 to 45 minutes. The interviews were started with an close-ended question, such as "Do you know the special approach that JCCPA has adopted?" and "Did the staff tell you about it at admission?", followed up by open-ended questions such as "What do you know about case management?" and "Can you tell me how your caregiving experience was with case manager support?". Subsequent probing questions aimed at clarification and gaining more insight on their experience, was guided by the participant's responses. Video-conferencing software such as Zoom, Google Meet, or facetime would be used for online interview. Interview would be conducted in JCCPA to ensure privacy of the participants.
All interviews were audio recorded and transcribed verbatim. The transcript were validated by re-listening to the tapes.
Constant comparative analysis was used for coding and category development. Incidents were identified in the data and coded. Initially, codes were identified as much as possible. Codes were compared to others codes. Codes were then collapsed into categories. In this process, incidents in a category were compared with previous incidents. New data was compared with data obtained earlier during the analysis phases. In intermediate coding, basic data was transformed into more abstract concepts allowing the theory to emerge from the data. Then, advanced coding was done to facilitate integration of the final grounded theory.
- Conditions
- Dementia
- Being tested
- Non-interventional
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Non-interventional. Interview would be conducted for data collection.
| Study group | Role | What they receive |
|---|---|---|
| Family caregivers | Family caregivers who were main caregiver to the person with dementia and who spent at least 10 hours a week providing care to the person with dementia. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured interview would be conducted individually
for data collection to explore the perspective of family caregivers on case manager approach in dementia care.
Measured: 2/5/2021-31/7/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start2 May 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Jockey Club Centre for Positive Ageing
- Responsible party
- Principal investigator, Lui Kam Yan, Chinese University of Hong Kong
- Investigators
- Kam Yan Lui, Miss, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845789
- Sponsor's protocol ID
- CaseManagerDementiaGT
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication. No identifying information about the individual would be revealed by using subject number
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Manager Approach in Dementia Care From a Caregiver Perspective: A Grounded Theory Study
- ClinicalTrials.gov ID
- NCT04845789
- Acronym / sponsor ID
- CaseManagerDementiaGT
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Jockey Club Centre for Positive Ageing
- Study start
- 2 May 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 15 Apr 2021 (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.
This is a qualitative study to explore opinions of family caregivers of community-dwelling people with dementia on case manager approach in dementia care. Semi-structured interviews will be used for data collection. Purposive sampling was used to recruit caregivers from Jockey Club Centre for Positive Ageing. Grounded Theory would be used for data analysis.
Detailed description
This was a qualitative study using semi-structured interviews with caregivers of community-dwelling people with dementia. Purposive sampling was used to recruit caregivers from Jockey Club Centre for Positive Ageing.
Study protocol would be explained by principal investigator (PI) to case managers in JCCPA, including aim and objectives of the study, inclusion criteria, exclusion criteria and interview questions.
Due to privacy issues, case managers in JCCPA would screen family caregivers and ask for consent to participate in the study. Contact method of caregivers would be provided to PI by JCCPA case managers upon caregivers' consent. PI would then approach caregivers to arrange online meetings and send the online consent form to them for their consideration and reference. Risks and benefits of the study and the right to withdraw from the study at any time would be explained to participants before consent form was signed by participants digitally.
Demographic data such as age, gender, education level, years of caregiving to PWD and time spent on caregiving would be collected using Google form.
All interviews were conducted through video-conferencing individually. Each interview took 30 to 45 minutes. The interviews were started with an close-ended question, such as "Do you know the special approach that JCCPA has adopted?" and "Did the staff tell you about it at admission?", followed up by open-ended questions such as "What do you know about case management?" and "Can you tell me how your caregiving experience was with case manager support?". Subsequent probing questions aimed at clarification and gaining more insight on their experience, was guided by the participant's responses.
Demographic data such as age, gender, education level, years of caregiving to PWD and time spent on caregiving would be collected using Google form.
All interviews were conducted through video-conferencing individually. Each interview took 30 to 45 minutes. The interviews were started with an close-ended question, such as "Do you know the special approach that JCCPA has adopted?" and "Did the staff tell you about it at admission?", followed up by open-ended questions such as "What do you know about case management?" and "Can you tell me how your caregiving experience was with case manager support?". Subsequent probing questions aimed at clarification and gaining more insight on their experience, was guided by the participant's responses. Video-conferencing software such as Zoom, Google Meet, or facetime would be used for online interview. Interview would be conducted in JCCPA to ensure privacy of the participants.
All interviews were audio recorded and transcribed verbatim. The transcript were validated by re-listening to the tapes.
Constant comparative analysis was used for coding and category development. Incidents were identified in the data and coded. Initially, codes were identified as much as possible. Codes were compared to others codes. Codes were then collapsed into categories. In this process, incidents in a category were compared with previous incidents. New data was compared with data obtained earlier during the analysis phases. In intermediate coding, basic data was transformed into more abstract concepts allowing the theory to emerge from the data. Then, advanced coding was done to facilitate integration of the final grounded theory.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family caregivers | – | Other: Non-interventionalFamily caregivers who were main caregiver to the person with dementia and who spent at least 10 hours a week providing care to the person with dementia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Family caregivers of person with dementia
Key inclusion criteria (3 listed)
- care recipients having clinical diagnosis of dementia of any stage
- participants being the family caregivers of care recipients, providing care for at least 10 hours per week
- caregivers receiving case manager support for at least 3 months
Key exclusion criteria (3 listed)
- caregivers who were under age of 18 and those exhibiting intellectual impairment
- caregivers who were not immediate family members of care recipients
- caregivers who could not communicate in Cantonese or English
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 |
|---|---|---|
| Non-interventionalNon-interventional. Interview would be conducted for data collection. | Other | Family caregivers |
Primary outcome
Semi-structured interview would be conducted individually
Time frame: 2/5/2021-31/7/2021
for data collection to explore the perspective of family caregivers on case manager approach in dementia care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication. No identifying information about the individual would be revealed by using subject number
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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.
Kam Yan Lui, Miss principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 3 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 15 Apr 2021. 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 Hong Kong. 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 Kam Yan Lui, Miss (+85263329630, 1155138933@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured interview would be conducted individually (time frame: 2/5/2021-31/7/2021). 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 15 Apr 2021.