Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202102670906630 Date of Approval: 10/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of faith-based interventions on the rate of discharge against medical advice in the tertiary newborn units in Nigeria: A protocol for randomized control trial.
Official scientific title Effectiveness of faith-based interventions on the rate of discharge against medical advice in the tertiary newborn units in Nigeria: A protocol for open-label, parallel randomized control trial
Brief summary describing the background and objectives of the trial Discharged against medical advice (DAMA) is a risk factor that often leads to adverse outcomes and hospital re-admissions in neonatal units. Few studies have shown that spiritual/faith-based institutions (FBI) tend to have a lower incidence of DAMA compared with public hospitals. Perhaps the holistic approach to patient care that addresses the spiritual needs, the soul, and the body component of a being in this setting may account for the observed lower incidence of DAMA. Limited randomized control trials (RCT) exist on faith-based interventions with regards to DAMA in published literature. This study seeks to compare the effectiveness of the FBI on neonatal DAMA against the standard of care in tertiary hospitals in Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FBIDAMA
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/03/2021
Actual trial start date 01/03/2021
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 30/11/2021
Anticipated target sample size (number of participants) 377
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL www.themping.org
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Faith based intervention 2-3 religious counseling sessions 20-30 minutes per episode Religious counseling including prayers, reading of holy books, and encouragements to caregivers/parents to stay in the hospital until their baby is medically discharged. 184
Control Group Standard of care not applicable Not applicable Standard of care: being discharged based on medical advice. 184 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All newborns admitted into selected public hospitals whose parents /caregivers gave their consent to participate in the study. Babies whose parents/ caregivers fail to give consent for the study Babies taken custody of by institutions such as motherless homes or by government agencies for legal reasons. New born: 0 Day-1 Month 1 Day(s) 28 Day(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/12/2020 Ministry of Health Department of Planing Research and Statistics
Ethics Committee Address
Street address City Postal code Country
Agodi Secretariat Ibadan Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of this study is the retention rate of sick newborns with the faith-based intervention in public tertiary hospitals in Nigeria compared with the standard of care. One time point- until there is DAMA or medical discharge.
Secondary Outcome The secondary outcomes are reasons and determinants of DAMA among the neonates in the tertiary hospitals in Nigeria. one time point- until DAMA occurs or medical discharge.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Ibadan Queens Road Ibadan 200212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Michael Abel Alao Layi Ayanniyi Street, Ibadan Ibadan 200212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Michael Alao University College Hospital Ibadan Ibadan 200212 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Emmanuel Nna The Molecular Pathology Institute, Enugu Enugu 400001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Alao mikefountains@yahoo.com +2348053967839 Layi Ayanniyi Street, Ibadan
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Consultant Paediatrician University College Ibadan
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Nna e.nna@themping.org +2347063415385 44 RANGERS AVENUE INDEPENDENCE LAYOUT
City Postal code Country Position/Affiliation
ENUGU 400001 Nigeria Managing Director The Molecular Pathology institute
Role Name Email Phone Street address
Public Enquiries Ibrahim Olayinka Rasheed ibroplus@gmail.com +2348066188403 Department of Paediatrics, Federal Medical Centre, Along Jibya Bypass Road,
City Postal code Country Position/Affiliation
Katsina 820241 Nigeria Consultant Paediatrician FMC Katsina
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Patient data will be de-identified and stored encrypted in a passworded computer. The de-identified data will be publicly available for 2 years on the trial website. De-identified data will also be stored in highly secured clouding computing. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The Informed Consent Form will be redacted before sharing publicly. Patient identifiers will be removed from all documents for public access. Open access to de-identified data set which can be used for any analysis related to discharged against medical advice (DAMA)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.themping.org No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information