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

NCT ID: NCT04866316

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frailty Frail Elderly Syndrome Frailty Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GSH Participants

Qualitative - 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

There is no active intervention as this is a service evaluation

Intervention Type OTHER

There is no active intervention as this is a service evaluation

Policy owners, implementers & care partners, health and social care professionals

Qualitative - 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

There is no active intervention as this is a service evaluation

Intervention Type OTHER

There is no active intervention as this is a service evaluation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

There is no active intervention as this is a service evaluation

There is no active intervention as this is a service evaluation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

2. Qualitative Focus group discussions/ Implementation team

* Individuals with time funded through the programme who have been providing services in the GSH for at least six month

3. Qualitative Focus group discussions/ partner organizations

* healthcare professionals and administrative staff who provided services within the new programme for at least six months

4. Qualitative Focus group discussions/ GSH participants

* Participants who receive care under the new model for at least three months

5. Quantitative survey questionnaire / GSH participants


* Patients that meet the necessary clinical criteria for enrollment in the respective GSH programme
* Age: 65 and above
* Clinical Frailty Score (CFS): 4-7
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexandra Hospital

OTHER

Sponsor Role collaborator

Changi General Hospital

OTHER

Sponsor Role collaborator

Ng Teng Fong General Hospital

OTHER

Sponsor Role collaborator

Sengkang General Hospital

OTHER

Sponsor Role collaborator

Singapore General Hospital

OTHER

Sponsor Role collaborator

Geriatric Education and Research Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Woan Shin Tan, PhD

Role: PRINCIPAL_INVESTIGATOR

Joint Faculty and PI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Geriatric Education and Research Institite

Singapore, , Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35840898 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019/00925

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.