Implementing Family Participation Training in Tertiary Hospital Care in Bangladesh

NCT07232901 | Completed DMC

• 1 other identifier: FAMCARE
• Study Type: interventional
• Target: 1,029
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Family Caregiver: Strain

  Measured with Care-related Quality of Life (CarerQOL), ranging from 0 (worst care situation) to 100 (best care situation)

  During 5 day hospital follow-up

• Health Worker: Workload

  Nasa Task Load Index, ranging from 0 (low workload) to 10 (high workload)

  Assessed from inclusion till study end for at least once per study period across four periods, spanning five months in total

• Refined Programme Theories from the Realist Evaluation

  The 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.

  Continuous refinement from start of the intervention till end of the study, spanning four months in total

Secondary Outcomes (6)

• Family Caregiver: Workload

  During 5 day hospital follow-up

• Family Caregiver: Caregiving Tasks Performed During Hospitalisation

  During 5 day hospital follow-up

• Family Caregiver: Readiness for Discharge

  During 5 day hospital follow-up

• Family Caregiver: Satisfaction with Hospital Care

  During 5 day hospital follow-up and at 14 day call

• Health Worker: Families' Importance in Nursing Care

  Assessed from inclusion till study end for at least once per study period across four periods, spanning five months in total

Other Outcomes (11)

• Patient: Satisfaction with Hospital Care

  During 5 day hospital follow-up

• Patient: Anxiety and Depression

  During 5 day hospital follow-up

• Patient: Readiness for Discharge

  During 5 day hospital follow-up

Study Arms (2)

Standard care

NO INTERVENTION

Control: Hospital care as usual.

Family Caregiver Training

EXPERIMENTAL

Intervention: Family Caregiver Training in hospital.

Behavioral: Family Caregiver Training

Interventions

Family Caregiver Training BEHAVIORAL

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.

Family Caregiver Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michele van Vugt: lead
• Chittagong Medical College and Hospital: collaborator
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• Asian University for Women: collaborator
• Noora Health: collaborator
• Mixit: collaborator
• Amsterdam UMC: collaborator

Study Sites (1)

Chittagong Medical College Hospital

Chittagong, Bangladesh

Location

Study Officials

• Michèle van Vugt, Prof. Dr.

  Amsterdam University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unable to mask a training intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Stepped-wedge trial

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: November 18, 2025
• Study Start: August 9, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 12, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)