CaregiversNCT05205135
Feasibility Study of Project Carer Matters for Family Caregivers of Persons With Dementia
An observational study of Caregivers and Caregiver Burden, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
The study uses the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to assess the Carer Matters programme for dementia caregivers in Singapore. A parallel mixed-methods study design is applied to assess the programme's feasibility and effectiveness. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Caregiver Burden, Caregiver Burnout
- What is being tested?
- SHARE Programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 55 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2021to 1 Feb 2022
- 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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All eligible caregivers whose person with dementia are admitted into the pilot wards and receive the SHARE programme will be invited to participate All eligible ward nurses and clinicians who work in pilot wards where SHARE is ongoing will be invited to participate. All eligible care support nurses and programme facilitators will be invited to participate, as they are all involved in SHARE. Eligible hospital leaders and community leaders who have worked with the SHARE programme will be invited to participate.
Who may be able to join
- For family caregivers: (1) Above 21 years of age, (2) The main family caregiver of the PwD receiving home-based care, (3) Able to converse in English language, and (4) Willing to have their interviews audio-recorded.
- For ward nurses: (1) Above 21 years of age, (2) Working as a nurse at one of the inpatient wards piloting SHARE, (3) Referred family caregivers to complete the brief screening tool, and (4) Willing to have their interviews audio-recorded.
- For care support nurses: (1) Above 21 years of age, (2) Involved in either providing direct or indirect patient care to a PwD and their caregiver through SHARE, and (3) Willing to have their interviews audio-recorded.
- For community leaders and hospital leaders: (1) Above 21 years of age, (2) Key decision makers or in leadership positions within the hospital or Working in institutions where there are ongoing or potentially future partnerships with TTSH to provide care services , and (3) Willing to have their interviews audio-recorded.
- For other clinicians: (1) Above 21 years of age, (2) Working as a clinicians at one of the inpatient wards piloting SHARE, (3) Referred family caregivers to complete the brief screening tool, and (4) Willing to have their interviews audio-recorded.
- Exclusion Criteria: any potential participant who refuses to have their interviews recorded
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Project Carer Matters for Family Caregivers of People With Dementia Receiving Home-based Caregiving
The study uses the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to assess the Carer Matters programme for dementia caregivers in Singapore. A parallel mixed-methods study design is applied to assess the programme's feasibility and effectiveness.
Read the detailed description
A mixed-methods study to (1) Evaluate the feasibility of Carer Matters for caregivers of PwD and to (2) Explore perspectives of key stakeholders who are directly or indirectly involved with Carer Matters, to better understand the potential sustainability of this framework.
The objectives of are as follows:
- To explore the perceptions, attitudes and beliefs of family caregivers, healthcare workers and community partners towards Carer Matters.
- To explore the barriers and facilitators of acceptance and implementation of Carer Matters.
- To gain insights into the perceived demand of Carer Matters.
- To gain insights into the family caregivers' preliminary responses to and outcomes from Carer Matters.
The study will involve six inpatient wards of a 1,700-bedded tertiary care hospital which are piloting Carer Matters. These wards comprise of four acute wards and two sub-acute wards. They are selected as they admit a comparatively greater number of patients with dementia than other wards in the hospital. The study will be conducted over 12 months.
Quantitative data is based off programme data collected from all caregivers who undergo Carer Matters. Hence, it will consist of all dementia caregivers whose care recipient is admitted into the pilot wards and agree to participate in Carer Matters.
Qualitative data is based off interviews of key stakeholders of the different components of the Carer Matters programme. The key stakeholders comprises: (1) Family caregivers of PwD (n = 25 to 30), (2) Ward nurses (n= 8 to 10), (3) Care support nurses (n = 2 to 3), (4) Intervention programmes facilitators and standardized patients (n = 3), (5) Community partners and hospital leaders (n = 4), and (6) Other clinicians - medical social workers, physiotherapists, occupational therapists and doctors (n = 4 to 5).
Both qualitative and quantitative data will be triangulated using the RE-AIM framework address the research objectives of the study. These insights will then be used to generate an updated Theory of Change model explaining how SHARE improves caregiver capacity for sustained caregiving. This final model will reflect the processes and mechanisms of Carer Matters that contribute towards the short, medium and long-term outcomes intended, and can serve as a guide for future researchers and practitioners.
- Conditions
- Caregivers, Caregiver Burden, Caregiver Burnout, Dementia
- Being tested
- SHARE Programme
- Keywords
- Feasibility studies, Caregiver, Nursing, Older person, Singapore
- Medical subject headings
- Caregiver Burden, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHARE ProgrammeBehavioural
SHARE is Singapore's first 'Hospital-to-Home' programme to screen, identify and provide targeted interventions for caregivers at-risk of caregiver burden. Our interventions include psychosocial and emotional preparation of caregivers' mental resilience, and long-term engagement initiatives to connect caregivers into an integrated network of peers and community support services, delivered by programme facilitators and care support nurses.
Key stakeholders essential for the success of share include ward nurses and clinicians who refer caregivers to SHARE and community partners and hospital leaders.
This study seeks to recruit all of these individuals to better understand their experience of SHARE and the facilitators and barriers to its successful rollout to better evaluate the feasibility of SHARE in the hospital to home setting.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Caregivers of persons with dementia supported by the Carer Matters programme Receives: Behavioral: SHARE Programme | |
| Nurses | Ward nurses who collaborate with the Carer Matters team Receives: Behavioral: SHARE Programme | |
| Programme facilitators | Facilitators of programmes organised through Carer Matters Receives: Behavioral: SHARE Programme | |
| Care Support Nurses | Nurses trained to deliver support and assistance as part of Carer Matters Programme Receives: Behavioral: SHARE Programme | |
| Community partners and hospital leaders | Key policy makers and community leaders who partner with the Carer Matters programme to ensure its success Receives: Behavioral: SHARE Programme | |
| Other clinicians (e.g. Social workers, Physiotherapists, doctors) | Other clinicians who refer caregivers to the Carer Matters programme Receives: Behavioral: SHARE Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited into programme
Reach of Carer Matters - Whether Carer Matters Programme affects target population of caregivers. Data collected from programme logs of caregivers recruited not programme and sign-up rates for programmes recommended to participants
Measured: Data will be collected over one year, the duration of the first year of the intervention.
Self-reported anxiety scores of CARERS programme participants
Whether Carer Matters Programme brings about the desired effects in caregiver participants - Reduced anxiety. Data collected through HADS tool administered to caregivers attending CARERS programme.
Measured: Data will be collected over one year, the duration of the first year of the intervention.
Self-reported depression scores of CARERS programme participants
Whether Carer Matters Programme brings about the desired effects in caregiver participants - Reduced depressive symptoms. Data collected through HADS tool administered to caregivers attending CARERS programme.
Measured: Data will be collected over one year, the duration of the first year of the intervention.
Self-reported dementia knowledge scores of dementia programme participants
Whether Carer Matters Programme brings about the desired effects in caregiver participants - Increased dementia knowledge. Data collected through dementia knowledge test designed by team, administered to caregivers attending dementia programme.
Measured: Data will be collected over one year, the duration of the first year of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Mar 2021
- Primary completion30 Nov 2021
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Geriatric Education and Research Institute
- Responsible party
- Sponsor
- Investigators
- Ee Yuee Chan, PhD, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205135
- Sponsor's protocol ID
- GERI1626
- Status last verified
- Jan 2022
- First submitted
- 29 Dec 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans for IPD sharing, due to sensitivity of information shared over interviews.
Publications
Wu LT, Glass GF Jr, Chew EYH, Ng EJY, Chan EY. Developing a theory of change to guide the design and implementation of a caregiver-centric support service. BMC Health Serv Res. 2024 Dec 18;24(1):1620. doi: 10.1186/s12913-024-11931-y.
PubMed 39695613Chan EY, Wu LT, Ng EJY, Glass GF Jr, Tan RHT. Applying the RE-AIM framework to evaluate a holistic caregiver-centric hospital-to-home programme: a feasibility study on Carer Matters. BMC Health Serv Res. 2022 Jul 19;22(1):933. doi: 10.1186/s12913-022-08317-3.
PubMed 35854296
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Project Carer Matters for Family Caregivers of People With Dementia Receiving Home-based Caregiving
- ClinicalTrials.gov ID
- NCT05205135
- Acronym / sponsor ID
- GERI1626
- Conditions
- Caregivers, Caregiver Burden, Caregiver Burnout, Dementia
- Keywords
- Feasibility studies, Caregiver, Nursing, Older person, Singapore
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Geriatric Education and Research Institute
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 24 Jan 2022 (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 study uses the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to assess the Carer Matters programme for dementia caregivers in Singapore. A parallel mixed-methods study design is applied to assess the programme's feasibility and effectiveness.
Detailed description
A mixed-methods study to (1) Evaluate the feasibility of Carer Matters for caregivers of PwD and to (2) Explore perspectives of key stakeholders who are directly or indirectly involved with Carer Matters, to better understand the potential sustainability of this framework.
The objectives of are as follows:
- To explore the perceptions, attitudes and beliefs of family caregivers, healthcare workers and community partners towards Carer Matters.
- To explore the barriers and facilitators of acceptance and implementation of Carer Matters.
- To gain insights into the perceived demand of Carer Matters.
- To gain insights into the family caregivers' preliminary responses to and outcomes from Carer Matters.
The study will involve six inpatient wards of a 1,700-bedded tertiary care hospital which are piloting Carer Matters. These wards comprise of four acute wards and two sub-acute wards. They are selected as they admit a comparatively greater number of patients with dementia than other wards in the hospital. The study will be conducted over 12 months.
Quantitative data is based off programme data collected from all caregivers who undergo Carer Matters. Hence, it will consist of all dementia caregivers whose care recipient is admitted into the pilot wards and agree to participate in Carer Matters.
Qualitative data is based off interviews of key stakeholders of the different components of the Carer Matters programme. The key stakeholders comprises: (1) Family caregivers of PwD (n = 25 to 30), (2) Ward nurses (n= 8 to 10), (3) Care support nurses (n = 2 to 3), (4) Intervention programmes facilitators and standardized patients (n = 3), (5) Community partners and hospital leaders (n = 4), and (6) Other clinicians - medical social workers, physiotherapists, occupational therapists and doctors (n = 4 to 5).
Both qualitative and quantitative data will be triangulated using the RE-AIM framework address the research objectives of the study. These insights will then be used to generate an updated Theory of Change model explaining how SHARE improves caregiver capacity for sustained caregiving. This final model will reflect the processes and mechanisms of Carer Matters that contribute towards the short, medium and long-term outcomes intended, and can serve as a guide for future researchers and practitioners.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Behavioral: SHARE ProgrammeCaregivers of persons with dementia supported by the Carer Matters programme |
| Nurses | – | Behavioral: SHARE ProgrammeWard nurses who collaborate with the Carer Matters team |
| Programme facilitators | – | Behavioral: SHARE ProgrammeFacilitators of programmes organised through Carer Matters |
| Care Support Nurses | – | Behavioral: SHARE ProgrammeNurses trained to deliver support and assistance as part of Carer Matters Programme |
| Community partners and hospital leaders | – | Behavioral: SHARE ProgrammeKey policy makers and community leaders who partner with the Carer Matters programme to ensure its success |
| Other clinicians (e.g. Social workers, Physiotherapists, doctors) | – | Behavioral: SHARE ProgrammeOther clinicians who refer caregivers to the Carer Matters programme |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible caregivers whose person with dementia are admitted into the pilot wards and receive the SHARE programme will be invited to participate All eligible ward nurses and clinicians who work in pilot wards where SHARE is ongoing will be invited to participate. All eligible care support nurses and programme facilitators will be invited to participate, as they are all involved in SHARE. Eligible hospital leaders and community leaders who have worked with the SHARE programme will be invited to participate.
Key inclusion criteria (7 listed)
- For family caregivers: (1) Above 21 years of age, (2) The main family caregiver of the PwD receiving home-based care, (3) Able to converse in English language, and (4) Willing to have their interviews audio-recorded.
- For ward nurses: (1) Above 21 years of age, (2) Working as a nurse at one of the inpatient wards piloting SHARE, (3) Referred family caregivers to complete the brief screening tool, and (4) Willing to have their interviews audio-recorded.
- For care support nurses: (1) Above 21 years of age, (2) Involved in either providing direct or indirect patient care to a PwD and their caregiver through SHARE, and (3) Willing to have their interviews audio-recorded.
- For community leaders and hospital leaders: (1) Above 21 years of age, (2) Key decision makers or in leadership positions within the hospital or Working in institutions where there are ongoing or potentially future partnerships with TTSH to provide care services , and (3) Willing to have their interviews audio-recorded.
- For other clinicians: (1) Above 21 years of age, (2) Working as a clinicians at one of the inpatient wards piloting SHARE, (3) Referred family caregivers to complete the brief screening tool, and (4) Willing to have their interviews audio-recorded.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SHARE ProgrammeSHARE is Singapore's first 'Hospital-to-Home' programme to screen, identify and provide targeted interventions for caregivers at-risk of caregiver burden. Our interventions include psychosocial and emotional preparation of caregivers' mental resilience, and long-term engagement initiatives to connect caregivers into an integrated network of peers and community support services, delivered by programme facilitators and care support nurses. Key stakeholders essential for the success of share include ward nurses and clinicians who refer caregivers to SHARE and community partners and hospital leaders. This study seeks to recruit all of these individuals to better understand their experience of SHARE and the facilitators and barriers to its successful rollout to better evaluate the feasibility of SHARE in the hospital to home setting. | Behavioural | Care Support Nurses, Caregivers, Community partners and hospital leaders, Nurses, Other clinicians (e.g. Social workers, Physiotherapists, doctors), Programme facilitators |
Primary outcome
Number of participants recruited into programme
Time frame: Data will be collected over one year, the duration of the first year of the intervention.
Reach of Carer Matters - Whether Carer Matters Programme affects target population of caregivers. Data collected from programme logs of caregivers recruited not programme and sign-up rates for programmes recommended to participants
Self-reported anxiety scores of CARERS programme participants
Time frame: Data will be collected over one year, the duration of the first year of the intervention.
Whether Carer Matters Programme brings about the desired effects in caregiver participants - Reduced anxiety. Data collected through HADS tool administered to caregivers attending CARERS programme.
Self-reported depression scores of CARERS programme participants
Time frame: Data will be collected over one year, the duration of the first year of the intervention.
Whether Carer Matters Programme brings about the desired effects in caregiver participants - Reduced depressive symptoms. Data collected through HADS tool administered to caregivers attending CARERS programme.
Self-reported dementia knowledge scores of dementia programme participants
Time frame: Data will be collected over one year, the duration of the first year of the intervention.
Whether Carer Matters Programme brings about the desired effects in caregiver participants - Increased dementia knowledge. Data collected through dementia knowledge test designed by team, administered to caregivers attending dementia programme.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 39695613Wu LT, Glass GF Jr, Chew EYH, Ng EJY, Chan EY. Developing a theory of change to guide the design and implementation of a caregiver-centric support service. BMC Health Serv Res. 2024 Dec 18;24(1):1620. doi: 10.1186/s12913-024-11931-y.
- Derived from this study: PubMed 35854296Chan EY, Wu LT, Ng EJY, Glass GF Jr, Tan RHT. Applying the RE-AIM framework to evaluate a holistic caregiver-centric hospital-to-home programme: a feasibility study on Carer Matters. BMC Health Serv Res. 2022 Jul 19;22(1):933. doi: 10.1186/s12913-022-08317-3.
- Individual participant dataSharing planned: No. No plans for IPD sharing, due to sensitivity of information shared over interviews.
Related trials for Caregivers
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Recruiting
A Web-Based Dyadic Intervention for Colorectal Cancer
Colorectal Carcinoma
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.
Ee Yuee Chan, PhD principal investigator
Tan Tock Seng Hospital
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 Caregivers and Caregiver Burden, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 7 inclusion and 0 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 Jan 2022. 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 Singapore. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited into programme (time frame: Data will be collected over one year, the duration of the first year of the intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05205135, which also lists 2 linked publications.
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 Jan 2022.