AzTrials
AzTrials

FrailtyNCT04866316

Protocol for Multi-site Evaluation of New Community-based Frailty Programme

An observational study of Frailty and Frail Elderly Syndrome, run by Geriatric Education and Research Institute at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: Frailty is increasing in prevalence internationally with population ageing. Frailty can be managed or even reversed through community-based interventions delivered by a multi-disciplinary team of professionals, but to varying degrees of effectiveness. Read more about this study

Who is it for?
Ages 21 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Frailty, Frail Elderly Syndrome, Frailty Syndrome
What is being tested?
There is no active intervention as this is a service evaluation
How many people
335 participants
Where
1 siteSingapore
Study dates
1 Apr 2019to 30 Sep 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: Given that the study involves a mixed method evaluation evaluation methodology, to gain a comprehensive understanding of the factors influencing the effectiveness of the implementation approaches adopted by the GSH programmes, and their impacts, the study population will comprise of professional stakeholders playing critical roles in the development and implementation of the new model of community-based frailty care, and the participants of the GSH programme services .

Who may be able to join

  • Decision-makers who are higher-level administrators or clinicians who have the authority to make policy and implementation decisions and/ or
  • Individuals who are familiar with the hospital's overall frailty strategy; and/ or
  • Individuals that who led the development and implementation of the programme
  • Individuals with time funded through the programme who have been providing services in the GSH for at least six month
  • healthcare professionals and administrative staff who provided services within the new programme for at least six months
  • Participants who receive care under the new model for at least three months
Show all 9Show fewer
  • Patients that meet the necessary clinical criteria for enrollment in the respective GSH programme
  • Age: 65 and above
  • Clinical Frailty Score (CFS): 4-7

Who cannot join

  • Do not meet inclusion criteria above
  • Qualitative Focus group discussions/ Implementation team
  • Do not meet inclusion criteria above
  • Qualitative Focus group discussions/ partner organizations
  • Do not meet inclusion criteria above
  • Qualitative Focus group discussions/ GSH participants
Show all 9Show fewer
  • Do not meet inclusion criteria above
  • Quantitative survey questionnaire / GSH participants
  • Do not meet inclusion criteria above

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Geriatric Education and Research Institite

    Singapore, 768024

Other trials in Singapore

About this study

Official title: Protocol for a Mixed Methods and Multi-site Assessment of the Implementation Process and Outcomes of a New Community-based Frailty Programme

Background: Frailty is increasing in prevalence internationally with population ageing. Frailty can be managed or even reversed through community-based interventions delivered by a multi-disciplinary team of professionals, but to varying degrees of effectiveness. However, many of the implementation insights of these care models are contextual, and may not be applicable in different cultural contexts. The Geriatric Service Hub (GSH) is a novel frailty care programme in Singapore, that includes key components of frailty care such as comprehensive geriatric assessments, care coordination and the assembly of a multidisciplinary team. The aim of this study is to gain insights on the factors influencing the implementation approaches adopted by five participating sites, and the effectiveness of the programme.

Methods: We will adopt a mixed-methods approach that includes a qualitative evaluation among key stakeholders and participants taking part in the programme, through in depth-interviews and focus group discussions. The main topics covered includes factors that affected the development and implementation of each programme, operations and other contextual factors that influenced implementation outcomes. The quantitative evaluation (1) monitors each programme's care process through quality indicators, (2) a multiple-time point survey study to compare programme participants' pre- and post- outcomes on patient engagement (collaboRATE and 13-item Patient Activation Measure;PAM), healthcare experiences (Consumer Assessment of Healthcare Providers and System Clinician and Group Survey Version 3.0; CG-CAHPS), health status and quality of life (Barthel Index of Activities of Daily Living, fall counts, the EuroQol questionnaire and the Control, Autonomy, Self-realization and Pleasure scale; CASP-19), impact on caregivers (Zarit Burden Interview) and societal costs (Client Service Receipt Inventory). (3) A retrospective cohort design to assess healthcare and cost utilisation between participants of the programme and a propensity score matched comparator group.

Discussion: The GSH sites share a common goal to increasing accessibility of essential services to frail older adults, and providing comprehensive care. The results of this evaluation study will provide valuable evidence to the impact and effectiveness of the GSH, and inform to the design of similar programmes targeting frail older adults.

Being tested
There is no active intervention as this is a service evaluation
Keywords
frailty care, comprehensive geriatric assessment, care coordination, multidisciplinary team care
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • There is no active intervention as this is a service evaluationOther

    There is no active intervention as this is a service evaluation

Study groups in NCT04866316
Study groupRoleWhat they receive
GSH ParticipantsQualitative - Semi-structured focus group discussions with care recipients Quantitative - Pre-test post-test design using survey-based data collection Quantitative - Retrospective cohort design with propensity score matched comparators
Receives: Other: There is no active intervention as this is a service evaluation
Policy owners, implementers & care partners, health and social care professionalsQualitative - Semi-structured in-depth interview with key policy and programme decision-makers Qualitative - Semi-structured focus group discussions with health and social care professionals Qualitative - Participant observations Quantitative - Longitudinal monitoring of process indicators
Receives: Other: There is no active intervention as this is a service evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional status

    It is hypothesised that better functional status, might reduce the healthcare utilisation (emergency hospitalisation, nursing home admission), caregiver burden and the associated indirect cost. In turn, we might expect overall costs to be lower compared to the comparison group.

    Changes in functional status will be measured using the Barthel Index of Activities of Daily Living (ADL) and Count of falls questionnaire.

    Measured: April 2019 - September 2022

  2. Health outcomes

    It is hypothesised that better health outcomes, might reduce the healthcare utilisation (emergency hospitalisation, nursing home admission), caregiver burden and the associated indirect cost. In turn, we might expect overall costs to be lower compared to the comparison group.

    Health outcomes will be measured using Quality of Life Questionnaire (EuroQol-5D-5L) and 19-item Quality of Life Scale (CASP-19).

    Measured: April 2019 - September 2022

Secondary outcomes (3)

  1. Utilisation of appropriate services

    GSH sites offer a range of medical, social and other services through either direct provision or referrals. Given that the model is intended to bridge service gaps (conduct of Comprehensive Geriatric Assessment/ CGA in the community), in the short-term, we hypothesis an increase in the utilisation of appropriate services (rehabilitation, ambulatory services) in this time-limited programme.

    Utilisation of services will be measured using Client Service Receipt Inventory (CSRI).

    Measured: April 2019 - September 2022

  2. Patient Satisfaction

    GSH participants are expected to benefit from the comprehensive package of health and social services and multidisciplinary team approach. With better care coordination and improved access, it is likely to elicit a higher level of satisfaction relative to comparator groups.

    Patient satisfaction will be measured using the Consumer Assessment of Healthcare Providers and System Clinician \& Group Survey Version 3.0 (CG-CAHPS) tool.

    Measured: April 2019 - September 2022

  3. Shared decision making/ engagement

    Education of the client about self-care, and making decisions about potential care options with inputs from a multidisciplinary team, is expected to result in higher level of shared decision making and engagement relative to comparator groups.

    Shared decision making/ engagement will be measured using the collaboRATE For Patient - 5-point anchor scale, and 13-item Patient Activation Measure (PAM-13).

    Measured: April 2019 - September 2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2021
  2. Study start1 Apr 2019
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

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
335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04866316
Sponsor's protocol ID
2019/00925
Other IDs
2019
Status last verified
Aug 2022
First submitted
12 Apr 2021
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The information will not be shared due to confidentiality

Publications

  • Tan WS, Nai ZL, Tan HTR, Nicholas S, Choo R, Ginting ML, Tan E, Teng PHJ, Lim WS, Wong CH, Ding YY; Geriatric Services Hub Programme Group. Protocol for a mixed-methods and multi-site assessment of the implementation process and outcomes of a new community-based frailty programme. BMC Geriatr. 2022 Jul 15;22(1):586. doi: 10.1186/s12877-022-03254-6.

    PubMed 35840898

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Frail Elderly Syndrome, run by Geriatric Education and Research Institute 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 21 Feb 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Functional status (time frame: April 2019 - September 2022). 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?

On the ClinicalTrials.gov record for NCT04866316, which also lists 1 linked publication.

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 21 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in