Family Participation in Hospital CareFAMCARENCT07232901
Implementing Family Participation Training in Tertiary Hospital Care in Bangladesh
A study testing Family Caregiver Training in people with Family Participation in Hospital Care and Hospital Medicine, run by Michele van Vugt at 1 site in Bangladesh.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Participation in Hospital Care, Hospital Medicine, Training Family Caregivers
- What is being tested?
- Family Caregiver Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,029 participants
- Where
- 1 siteBangladesh
- Study dates
- 9 Aug 2025to 12 Jan 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Family Participation Training in Tertiary Hospital Care in Bangladesh: a Stepped-wedge Realist Trial
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:
Read more
- 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.
Read the 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.
- Being tested
- Family Caregiver Training
- Keywords
- Caregiver, Family, Hospital, Nursing, Co-creation, Stepped-wedge, Realist Evaluation, Training, Implementation, Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Caregiver TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Control: Hospital care as usual. |
| Family Caregiver Training | Experimental | Intervention: Family Caregiver Training in hospital. Receives: Behavioral: Family Caregiver Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Caregiver: Strain
Measured with Care-related Quality of Life (CarerQOL), ranging from 0 (worst care situation) to 100 (best care situation)
Measured: During 5 day hospital follow-up
Health Worker: Workload
Nasa Task Load Index, ranging from 0 (low workload) to 10 (high workload)
Measured: 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.
Measured: Continuous refinement from start of the intervention till end of the study, spanning four months in total
Secondary outcomes (6)
Family Caregiver: Workload
Nasa Task Load Index, ranging from 0 (low workload) to 10 (high workload)
Measured: During 5 day hospital follow-up
Family Caregiver: Caregiving Tasks Performed During Hospitalisation
Daily collection of which caregiving tasks were performed in the past 24 hours by the main family caregiver, other family caregivers and the patient themselves.
Measured: During 5 day hospital follow-up
Family Caregiver: Readiness for Discharge
The caregiver is asked daily how ready they would be to provide care at home if their relative would be discharged today.
Measured: During 5 day hospital follow-up
Family Caregiver: Satisfaction with Hospital Care
Adapted and shortened HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) Survey, measured on a four and ten point scale
Measured: During 5 day hospital follow-up and at 14 day call
Health Worker: Families' Importance in Nursing Care
Using the Families' Importance in Nursing Care - Nurses' Attitudes (FINC-NA), measured on a five point scale
Measured: Assessed from inclusion till study end for at least once per study period across four periods, spanning five months in total
Health Worker: Interruptions
Health workers are asked about their perceived increase or decrease in interruptions during work by family caregivers
Measured: Assessed from inclusion till study end for at least once per study period across four periods, spanning five months in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start9 Aug 2025
- Primary completion31 Dec 2025
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Participation in Hospital CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge trial
- Masking
- None (open label)
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michele van Vugt
- Sponsor type
- University, hospital or other
- Collaborators
- Chittagong Medical College and Hospital, Mahidol Oxford Tropical Medicine Research Unit, Asian University for Women, Noora Health, Mixit, Amsterdam UMC
- Responsible party
- Sponsor-investigator, Michele van Vugt, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Michèle van Vugt, Prof. Dr., Principal investigator, Amsterdam University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232901
- Sponsor's protocol ID
- FAMCARE
- Acronym
- FAMCARE
- Status last verified
- Jan 2026
- First submitted
- 2 Sep 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Family Participation Training in Tertiary Hospital Care in Bangladesh: a Stepped-wedge Realist Trial
- ClinicalTrials.gov ID
- NCT07232901
- Acronym / sponsor ID
- FAMCARE / FAMCARE
- Keywords
- Caregiver, Family, Hospital, Nursing, Co-creation, Stepped-wedge, Realist Evaluation, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- Michele van VugtUniversity, hospital or other
- Collaborators
- Chittagong Medical College and Hospital, Mahidol Oxford Tropical Medicine Research Unit, Asian University for Women, Noora Health, Mixit, Amsterdam UMC
- Study start
- 9 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge trial
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Control: Hospital care as usual. |
| Family Caregiver Training | Experimental | Behavioral: Family Caregiver TrainingIntervention: Family Caregiver Training in hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (8 listed)
- All
- Language - Unable to speak Bengali, Chittagonian or English
- Consent
- No consent given
- Unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Caregiver TrainingThis 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. | Behavioural | Family Caregiver Training |
Primary outcome
Family Caregiver: Strain
Time frame: During 5 day hospital follow-up
Measured with Care-related Quality of Life (CarerQOL), ranging from 0 (worst care situation) to 100 (best care situation)
Health Worker: Workload
Time frame: Assessed from inclusion till study end for at least once per study period across four periods, spanning five months in total
Nasa Task Load Index, ranging from 0 (low workload) to 10 (high workload)
Refined Programme Theories from the Realist Evaluation
Time frame: Continuous refinement from start of the intervention till end of the study, spanning four months in total
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.
6 secondary outcomes
Family Caregiver: Workload
Time frame: During 5 day hospital follow-up
Family Caregiver: Caregiving Tasks Performed During Hospitalisation
Time frame: During 5 day hospital follow-up
Family Caregiver: Readiness for Discharge
Time frame: During 5 day hospital follow-up
Family Caregiver: Satisfaction with Hospital Care
Time frame: During 5 day hospital follow-up and at 14 day call
Health Worker: Families' Importance in Nursing Care
Time frame: Assessed from inclusion till study end for at least once per study period across four periods, spanning five months in total
Health Worker: Interruptions
Time frame: Assessed from inclusion till study end for at least once per study period across four periods, spanning five months in total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michèle van Vugt, Prof. Dr. principal investigator
Amsterdam University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Caregiver Training in people with Family Participation in Hospital Care and Hospital Medicine, run by Michele van Vugt at 1 site in Bangladesh.
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 17 inclusion and 8 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 26 Jan 2026. 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 Bangladesh. 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?
Family Caregiver: Strain (time frame: During 5 day hospital follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.