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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05205135
Other study ID # GERI1626
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date February 1, 2022

Study information

Verified date January 2022
Source Tan Tock Seng Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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: 1. To explore the perceptions, attitudes and beliefs of family caregivers, healthcare workers and community partners towards Carer Matters. 2. To explore the barriers and facilitators of acceptance and implementation of Carer Matters. 3. To gain insights into the perceived demand of Carer Matters. 4. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 55
Est. completion date February 1, 2022
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 99 Years
Eligibility Inclusion Criteria: - 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 -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SHARE Programme
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.

Locations

Country Name City State
Singapore Tan Tock Seng Hospital Singapore

Sponsors (2)

Lead Sponsor Collaborator
Tan Tock Seng Hospital Geriatric Education and Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Data will be collected over one year, the duration of the first year of the intervention.
Primary 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. Data will be collected over one year, the duration of the first year of the intervention.
Primary 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. Data will be collected over one year, the duration of the first year of the intervention.
Primary 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. Data will be collected over one year, the duration of the first year of the intervention.
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