Hospitalized PatientsNCT06632275
Family Participation in Bangladesh Hospital Care
An observational study of Hospitalized Patients, run by Michele van Vugt at 1 site in Bangladesh.
Trial summary
This mixed methods study aims to understand family care participation in the adult medicine wards of Chattogram Medical College Hospital, Bangladesh. The main questions it aims to answer, from the perspective of the patient, family caregiver, nurse, doctor, ward assistant, and hospital administrator, are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalized Patients
- How many people
- 353 participants
- Where
- 1 siteBangladesh
- Study dates
- 26 Sep 2023to 27 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes the patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators admitted/caring/working on the general medicine wards of Chattogram Medical College Hospital.
Who may be able to join
- Population
- Patient: Admitted to the ward (in-patient)
- Family caregiver: caregiver providing care at the bedside of the patient on the ward
- Environment: Admitted to medicine wards 13, 14 or 16 of Chattogram Medical College Hospital
- Admission time: Admitted in the last 48 hours
- Adult: ≥18 years
Show all 18Show fewer
- Population: Nurses and doctors
- Environment: Working in the medicine wards 13, 14 or 16 of Chattogram Medical College Hospital
- Population
- Patient: Admitted to the ward (in-patient)
- Family caregiver: Caregiver providing care at the bedside of the patient on the ward
- Health workers: Nurses, doctors and ward assistants
- Hospital administrator: Managers and professors
- Environment
- Patient: Admitted to medicine wards 13, 14 or 16 of CMCH
- Family caregiver: Caring for their relative on wards 13, 14 or 16 of CMCH
- Health worker: Working on wards 13, 14 or 16 of CMCH
- Hospital administrator: Responsible for care delivery on wards 13, 14 or 16 of CMCH
Who cannot join
- Admission time: Planned discharge or transfer within the first 24 hours of admission
- Child: <18 years
- Previously enrolled in this study arm
- No consent given
- Time and Motion
- Previously enrolled in this study arm
Show all 19Show fewer
- No consent given
- Qualitative (interviews and focus group discussions)
- Population
- Patient: Unconscious or unable to participate in a conversation
- Family caregiver: Unable to leave the patient for reasons of safety
- Health worker: <6 months of work experience on wards 13, 14 or 16 of CMCH
- Hospital administrator: <6 months in a management role for wards 13, 14 or 16 of CMCH
- Admission time
- Patient: Admitted <48 hours
- Family caregiver: <8 cumulative hours present at patient bedside in last 48 hours
- Child: <18 years
- Previously enrolled in this study arm
- No consent given
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Caregiver Participation in Hospital Care in a Tertiary Hospital in Bangladesh: a Mixed Methods Study
This mixed methods study aims to understand family care participation in the adult medicine wards of Chattogram Medical College Hospital, Bangladesh. The main questions it aims to answer, from the perspective of the patient, family caregiver, nurse, doctor, ward assistant, and hospital administrator, are:
- What is the role of the family caregiver in hospital care?
- What is the perceived effect of family participation in hospital care?
- What are the barriers and facilitators experienced in family participation?
- What are suggestions for family participation interventions?
Read more
These questions will be answered with three study arms:
- A prospective observational cohort (population: patients and family caregivers)
- A time and motion study (population: nurses and doctors)
- Interviews and focus group discussions (population: patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators)
- Conditions
- Hospitalized Patients
- Keywords
- Family caregivers, Hospital, Adult, Bangladesh, Family, Care, Mixed method, Observational, Cohort, Prospective, Qualitative, Time and Motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Observational Cohort | Patient and family caregiver dyads will be recruited for a prospective cohort observation for at least 24 hours and a maximum of seven days. At inclusion, baseline and self-reported data from admission until inclusion will be collected. After inclusion, data will be collected every 24 hours on self-reported outcomes of the last 24 hours. Patients and family caregiver dyads will be followed until discharge, transfer to another department, death or a maximum of seven days of follow-up. If dyads stay longer than seven days, daily follow-up is ended and they are called once 14 days later to collect outcome data. | |
| Time and Motion | Nurses and doctors will be recruited for time-and-motion observations by a trained non-participant observer during their shift on the medicine ward. Observers will use a REDCap to record where, what, for how long and how health workers perform tasks and interactions during their shifts. Observations will take place in sets of two hours each. Approximate equal amounts of observations will be done on all medicine wards. Observations will occur on different days of the week, at different shifts during the day, and at different times during a shift to collect data from different care contexts. Baseline data of the shift is recorded at the start of the observation. | |
| Qualitative | The qualitative arm of the study involves interviews and focus group discussions with patients, family caregivers, nurses, doctors and hospital administrators. The FGDs and interviews will be performed in Bengali by a local researcher experienced in qualitative research. An interview guide is used to define themes for the conversations, however, the interviewer is encouraged to follow the flow of the conversation by changing the order of topics or asking additional questions. The main themes of the interview guide are (1) the role of family participation in hospital care, (2) the perceived effect of family participation, (3) the barriers and facilitators for family participation in hospital care, and (4) the opportunities for improving family caregiver participation in hospital care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of family participation in hospital care
The role of family participation will be described with data from:
- Prospective observational cohort: patient baseline characteristics, family caregiver baseline characteristics, care characteristics during follow-up (for example: tasks performed, number of caregivers present, hours caregiver is present), end of follow-up status (example: discharged, transferred, death).
- Interviews and FDG: with patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators.
Measured: During admission to the general medicine ward
The perceived effect of family participation in hospital care
The perceived effect of family participation will be described with data from:
- Time and motion: division of work time of nurses and doctors, time spend interacting with patients and family caregivers.
- Interviews and FDG: with patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators.
Measured: During admission to the general medicine ward
The barriers and facilitators of family participation in hospital care
The barriers and facilitators of family participation will be described with data from:
- Prospective observational cohort: patient baseline characteristics, family caregiver baseline characteristics, care characteristics during follow-up (for example: tasks performed, number of caregivers present, hours caregiver is present), end of follow-up status (example: discharged, transferred, death).
- Time and motion: division of work time of nurses and doctors, time spend interacting with patients and family caregivers.
- Interviews and FDG: with patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators.
Measured: During admission to the general medicine ward
The intervention suggestions for family participation in hospital care
The barriers and facilitators of family participation will be described with data from:
- Interviews and FDG: with patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators.
Measured: During admission to the general medicine ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start26 Sep 2023
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized PatientsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michele van Vugt
- Sponsor type
- University, hospital or other
- Collaborators
- Chattogram Medical College Hospital, Asian University for Women, Mahidol Oxford Tropical Medicine Research Unit, Amsterdam UMC, location AMC
- Responsible party
- Sponsor-investigator, Michele van Vugt, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632275
- Sponsor's protocol ID
- FPBDMM
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be requested from the research group.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Caregiver Participation in Hospital Care in a Tertiary Hospital in Bangladesh: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT06632275
- Acronym / sponsor ID
- FPBDMM
- Conditions
- Hospitalized Patients
- Keywords
- Family caregivers, Hospital, Adult, Bangladesh, Family, Care, Mixed method, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Michele van VugtUniversity, hospital or other
- Collaborators
- Chattogram Medical College Hospital, Asian University for Women, Mahidol Oxford Tropical Medicine Research Unit, Amsterdam UMC, location AMC
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 9 Oct 2024 (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.
This mixed methods study aims to understand family care participation in the adult medicine wards of Chattogram Medical College Hospital, Bangladesh. The main questions it aims to answer, from the perspective of the patient, family caregiver, nurse, doctor, ward assistant, and hospital administrator, are:
- What is the role of the family caregiver in hospital care?
- What is the perceived effect of family participation in hospital care?
- What are the barriers and facilitators experienced in family participation?
- What are suggestions for family participation interventions?
These questions will be answered with three study arms:
- A prospective observational cohort (population: patients and family caregivers)
- A time and motion study (population: nurses and doctors)
- Interviews and focus group discussions (population: patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective Observational Cohort | – | –Patient and family caregiver dyads will be recruited for a prospective cohort observation for at least 24 hours and a maximum of seven days. At inclusion, baseline and self-reported data from admission until inclusion will be collected. After inclusion, data will be collected every 24 hours on self-reported outcomes of the last 24 hours. Patients and family caregiver dyads will be followed until discharge, transfer to another department, death or a maximum of seven days of follow-up. If dyads stay longer than seven days, daily follow-up is ended and they are called once 14 days later to collect outcome data. |
| Time and Motion | – | –Nurses and doctors will be recruited for time-and-motion observations by a trained non-participant observer during their shift on the medicine ward. Observers will use a REDCap to record where, what, for how long and how health workers perform tasks and interactions during their shifts. Observations will take place in sets of two hours each. Approximate equal amounts of observations will be done on all medicine wards. Observations will occur on different days of the week, at different shifts during the day, and at different times during a shift to collect data from different care contexts. Baseline data of the shift is recorded at the start of the observation. |
| Qualitative | – | –The qualitative arm of the study involves interviews and focus group discussions with patients, family caregivers, nurses, doctors and hospital administrators. The FGDs and interviews will be performed in Bengali by a local researcher experienced in qualitative research. An interview guide is used to define themes for the conversations, however, the interviewer is encouraged to follow the flow of the conversation by changing the order of topics or asking additional questions. The main themes of the interview guide are (1) the role of family participation in hospital care, (2) the perceived effect of family participation, (3) the barriers and facilitators for family participation in hospital care, and (4) the opportunities for improving family caregiver participation in hospital care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes the patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators admitted/caring/working on the general medicine wards of Chattogram Medical College Hospital.
Key inclusion criteria (18 listed)
Key exclusion criteria (19 listed)
- Time and Motion
- Qualitative (interviews and focus group discussions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The role of family participation in hospital care
Time frame: During admission to the general medicine ward
The role of family participation will be described with data from: 1. Prospective observational cohort: patient baseline characteristics, family caregiver baseline characteristics, care characteristics during follow-up (for example: tasks performed, number of caregivers present, hours caregiver is present), end of follow-up status (example: discharged, transferred, death). 2. Interviews and FDG: with patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators.
The perceived effect of family participation in hospital care
Time frame: During admission to the general medicine ward
The perceived effect of family participation will be described with data from: 1. Time and motion: division of work time of nurses and doctors, time spend interacting with patients and family caregivers. 2. Interviews and FDG: with patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators.
The barriers and facilitators of family participation in hospital care
Time frame: During admission to the general medicine ward
The barriers and facilitators of family participation will be described with data from: 1. Prospective observational cohort: patient baseline characteristics, family caregiver baseline characteristics, care characteristics during follow-up (for example: tasks performed, number of caregivers present, hours caregiver is present), end of follow-up status (example: discharged, transferred, death). 2. Time and motion: division of work time of nurses and doctors, time spend interacting with patients and family caregivers. 3. Interviews and FDG: with patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators.
The intervention suggestions for family participation in hospital care
Time frame: During admission to the general medicine ward
The barriers and facilitators of family participation will be described with data from: 1. Interviews and FDG: with patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators.
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 12 Jun 2026.
- Individual participant dataSharing planned: Undecided. Data can be requested from the research group.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalized Patients, 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 18 inclusion and 19 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 12 Jun 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?
The role of family participation in hospital care (time frame: During admission to the general medicine ward). The study lists 4 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 12 Jun 2026.