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Implementing Family Participation Training in Tertiary Hospital Care in Bangladesh

Implementing Family Participation Training in Tertiary Hospital Care in Bangladesh: a Stepped-wedge Realist Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07232901
Acronym
FAMCARE
Enrollment
1029
Registered
2025-11-18
Start date
2025-08-09
Completion date
2026-01-12
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family Participation in Hospital Care, Hospital Medicine, Training Family Caregivers

Keywords

Caregiver, Family, Hospital, Nursing, Co-creation, Stepped-wedge, Realist Evaluation, Training, Implementation, Participation

Brief summary

The goal of this trial is to evaluate whether a family participation training intervention can reduce caregiver strain and health worker workload, and improve patient outcomes and collaboration in the medicine wards of Chittagong Medical College Hospital (CMCH). General objectives: * To assess the effect of a family participation training intervention on the medicine wards of CMCH. (Stepped-wedge) * To examine how, for whom and under what circumstances a family participation training intervention works. (Realist evaluation) Specific objectives: * To examine the implementation of a family participation training intervention. * To investigate the acceptability and feasibility of a family participation training intervention. The study will use a step-by-step roll-out, introducing training at different times in three wards, to see if it improves care compared to usual practice. Study participants will include adult patients, their family caregivers, nurses, doctors, ward assistants, and hospital administrators. Health workers will be trained to deliver sessions to family caregivers of hospitalised patients on hospital introduction, basic care tasks, warning sign detection, oral medication administration, caregiver handover, and discharge preparedness.

Detailed description

Background: In many resource-limited settings, understaffed hospitals rely on the families of patients to provide care during admission. Family participation in hospital care may include washing, toileting, feeding, administering medication, and detecting warning signs. Family participation in hospital care is commonplace at Chittagong Medical College Hospital (CMCH) and other hospitals in Bangladesh. These care tasks are often performed informally, untrained, and unsupported, resulting in a high mental and physical burden of care for family caregivers, unknown effects on patient outcomes and potentially an even higher workload for health workers. This study proposes to implement and evaluate a family participation training intervention in the general medicine wards of CMCH. Building on prior preparatory research, the intervention aims to reduce family caregiver strain, lower health workers' workloads, enhance patient outcomes and improve collaboration between family caregivers and health workers. Objective The primary objectives of the study are to assess the effect of a family participation training intervention on the medicine wards of CMCH and to examine how, for whom and under what circumstances a family participation training intervention works. Methods The study employs a stepped-wedge realist trial over six months in the CMCH medicine wards (13, 14, and 16). It involves adult patients, family caregivers, health workers (nurses, doctors, and ward assistants), and hospital administrators. Family caregivers will receive training to support their participation in hospital care, while nurses and doctors will be trained to deliver these sessions. The training will include an introduction to the hospital, basic hospital care, oral medication administration, detection of warning signs, handover between family caregivers, and discharge preparation. The primary outcomes are reduced family caregiver strain and lower health worker workload. Patient-family caregiver dyads will be followed daily for up to five days during admission and one call after discharge. Health workers will be followed throughout the study period. In addition, ward-level, implementation, feasibility, and acceptability outcomes will be collected. Some patients, family caregivers, health workers, and hospital administrators will be included in realist interviews or focus group discussions. The analysis will integrate mixed-effects modelling with a realist evaluation approach. Discussion This study will add a foundational piece of research to the family participation field, in resource-limited and -rich settings. It builds on the shared journey of this growing international research collaboration. No such previous research has been performed. It will be the first to test a co-created family participation training intervention in hospital care. In addition, it suggests new research methods by integrating a stepped-wedge design with a realist evaluation.

Interventions

BEHAVIORALFamily Caregiver Training

This study will test a family participation training intervention. Family caregivers will receive training on participating in hospital care while nurses and doctors receive training to train family caregivers. The family caregiver training sessions will be delivered during the intervention period in three wards to all family caregivers willing to attend the training session. The intervention has been co-created and piloted with patients, family caregivers, health workers, and hospital administrators. The content of the training will include an introduction to the hospital environment, basic care tasks, warning sign detection, oral medication administration, caregiver handover, and discharge preparedness. The content of the family caregiver training will be bundled in a visual poster. These posters will be hung on the walls across the medicine wards at the patients' bedsides.

Sponsors

Michele van Vugt
Lead SponsorOTHER
Chittagong Medical College and Hospital
CollaboratorOTHER
Mahidol Oxford Tropical Medicine Research Unit
CollaboratorOTHER
Asian University for Women
CollaboratorUNKNOWN
Noora Health
CollaboratorUNKNOWN
Mixit
CollaboratorUNKNOWN
Amsterdam UMC
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

Unable to mask a training intervention.

Intervention model description

Stepped-wedge trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All study parts Population * Patient: admitted to one of the three medicine ward * Family caregiver: caregiver providing care for a patient on one of the three medicine wards * Health worker: nurse, doctor or ward assistant working on one of the three medicine wards * Hospital administrator: professors or administrators responsible for or directly involved in policymaking or have operational oversight on one of the three medicine wards Adult \- Age: ≥18 years Data collection specific Patient and family caregiver data collection - Patient \& family caregiver dyad: admitted for ≤24 hours on the medicine wards Health worker data collection \- Employment: working on one of the medicine wards for at least one week Interviews, focus group discussions and observations * Patient: admitted ≥24 hours on the medicine wards * Family caregiver: caring for the patient ≥24 hours on the medicine wards During the intervention period * Patient: family caregiver of the patient has received the training * Family caregiver: has received the training

Exclusion criteria

All Language - Unable to speak Bengali, Chittagonian or English Consent * No consent given * Unable to give consent * Duplicates: Previously enrolled in the study Data collection specific Patient and family caregiver data collection \- Patient: Planned discharge ≤24 hours of admission to the medicine ward

Design outcomes

Primary

MeasureTime frameDescription
Refined Programme Theories from the Realist EvaluationContinuous refinement from start of the intervention till end of the study, spanning four months in totalThe refined programme theories will be developed through iterative analysis of qualitative and quantitative data, outlining what works in the intervention, for whom, and under what circumstances.
Family Caregiver: StrainDuring 5 day hospital follow-upMeasured with Care-related Quality of Life (CarerQOL), ranging from 0 (worst care situation) to 100 (best care situation)
Health Worker: WorkloadAssessed from inclusion till study end for at least once per study period across four periods, spanning five months in totalNasa Task Load Index, ranging from 0 (low workload) to 10 (high workload)

Secondary

MeasureTime frameDescription
Family Caregiver: Readiness for DischargeDuring 5 day hospital follow-upThe caregiver is asked daily how ready they would be to provide care at home if their relative would be discharged today.
Family Caregiver: Satisfaction with Hospital CareDuring 5 day hospital follow-up and at 14 day callAdapted and shortened HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) Survey, measured on a four and ten point scale
Health Worker: Families' Importance in Nursing CareAssessed from inclusion till study end for at least once per study period across four periods, spanning five months in totalUsing the Families' Importance in Nursing Care - Nurses' Attitudes (FINC-NA), measured on a five point scale
Health Worker: InterruptionsAssessed from inclusion till study end for at least once per study period across four periods, spanning five months in totalHealth workers are asked about their perceived increase or decrease in interruptions during work by family caregivers
Family Caregiver: WorkloadDuring 5 day hospital follow-upNasa Task Load Index, ranging from 0 (low workload) to 10 (high workload)
Family Caregiver: Caregiving Tasks Performed During HospitalisationDuring 5 day hospital follow-upDaily collection of which caregiving tasks were performed in the past 24 hours by the main family caregiver, other family caregivers and the patient themselves.

Countries

Bangladesh

Contacts

PRINCIPAL_INVESTIGATORMichèle van Vugt, Prof. Dr.

Amsterdam University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026