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CompletedNCT06632288Updated Oct 9, 2024

Family Participation in Ghana Hospital Care

An observational study in Hospitalized Patients, sponsored by Michele van Vugt. Completed at 1 site in Ghana. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Michele van Vugt · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
170
Ages
18 Years and older
Sex
All
01

Study summary

This mixed methods study aims to understand family care participation in the adult medicine wards of Korle Bu Teaching Hospital, Ghana. The main questions it aims to answer, from the perspective of the patient, family caregiver, nurse, doctor, ward assistant, and hospital administrator, are:

  1. What is the role of the family caregiver in hospital care?
  2. What is the perceived effect of family participation in hospital care?
  3. What are the barriers and facilitators experienced in family participation?
  4. What are suggestions for family participation interventions?

These questions will be answered with three study arms:

  1. A prospective observational cohort (population: patients and family caregivers)
  2. A time and motion study (population: nurses and doctors)
  3. Interviews and focus group discussions (population: patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators)
02

Conditions studied

  • Hospitalized Patients

Keywords

  • Family caregivers
  • Hospital
  • Adult
  • Family
  • Care
  • Mixed method
  • Observational
  • Cohort
  • Prospective
  • Qualitative
  • Time and Motion
  • Ghana
03

In context

Lead sponsor

Michele van Vugt is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study includes the patients, family caregivers, nurses, doctors, ward assistants, and hospital administrators admitted/caring/working in the medicine wards of Korle Bu Teaching Hospital.

Eligibility criteria

Prospective Observational Cohort

  • Inclusion Criteria

    • 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 a medicine ward of KBTH
    • Admission time: Admitted in the last 48 hours
    • Adult: ≥18 years
  • Exclusion criteria

    • 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

  • Inclusion Criteria

    • Population: Nurses and doctors
    • Environment: Working in a medicine wards of KBTH
  • Exclusion Criteria

    • Population: \<6 months of work experience on a medicine ward of KBTH
    • Previously enrolled in this study arm
    • No consent given

Qualitative (interviews and focus group discussions)

  • Inclusion Criteria

    • 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 a medicine ward of KBTH
    • Family caregiver: Caring for their relative on a medicine ward of KBTH
    • Health worker: Working on a ward medicine of KBTH
    • Hospital administrator: Responsible for care delivery of a medicine ward of KBTH
  • Exclusion Criteria

    • 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 a medicine ward of KBTH
    • Hospital administrator: \<6 months in a management role of a medicine ward of KBTH
    • Admission time
    • Patient: Admitted \<48 hours
    • Child: \<18 years
    • Previously enrolled in this study arm
    • No consent given
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
170 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 English, Twi or Ga 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.

06

What researchers measure

Primary outcomes

  1. The role of family participation in hospital care

    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.

    Time frame: During admission to the general medicine ward

  2. The perceived effect of family participation in hospital care

    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.

    Time frame: During admission to the general medicine ward

  3. The barriers and facilitators of family participation in hospital care

    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.

    Time frame: During admission to the general medicine ward

  4. The intervention suggestions for family participation in hospital care

    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.

    Time frame: During admission to the general medicine ward

07

Study locations

1 site
  • Korle Bu Teaching Hospital
    Accra, Ghana
08

References and documents

Individual participant data

Plan to share: Undecided — Data can be requested from the research group.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06632288
Lead sponsor
Michele van Vugt
Collaborators
Amsterdam UMC, location AMC, Korle Bu Teaching Hospital, University of Ghana Medical School
Responsible party
Michele van Vugt (Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Sponsor-investigator
First posted
Oct 9, 2024
Start date
Feb 12, 2024
Primary completion
May 24, 2024
Completion
May 24, 2024
Last update
Oct 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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