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.: PACTR201604001185358 Date of Registration: 30/06/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Integration ICF to facilitate interprofessional collaboration among Health Professionals in Rwanda district hospitals
Official scientific title Use of International Classification of Functioning, Disability and Health (ICF) as a Theoretical Framework to inform Inter-professional Assessment and Management by Health Care Professionals in Rwanda: A Cluster Randomised Control Trial.
Brief summary describing the background and objectives of the trial Background: Lancet Global Independent Commission has recommended a health care reform (Frenk,et al. 2010). Problems identified by the authors included (amongst others) poor teamwork among health care professionals. This may be due to a lack of common language to be used for a smooth collaboration between professionals, Hence the need for a training oriented towards an interprofessional management collaboration. ICF has been found to be a useful potential framework to help HCP provide a common language that looks beyond mortality and disease and instead look at how people live with their conditions (Kohler et al., 2013) Aim: To determine whether the International Classification of Functioning Disability and Health (ICF) can be used as a framework to inform interprofessional assessment and management within hospital settings in Rwanda and whether it¿s use will result in improved service delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CRCT
Disease(s) or condition(s) being studied
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 23/07/2015
Actual trial start date 10/11/2016
Anticipated date of last follow up 30/06/2016
Actual Last follow-up date 26/02/2016
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants) 203
Recruitment status Completed
Publication URL
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Inter-professional training One day Training session 8 hours training Training on Interprofessional Practice using the International Classification of Functioning, Disability and Health as collaborating tool 103
Experimental Group Inter-professional training One day Training session 8 hours training Training on Interprofessional Practice using the International Classification of Functioning, Disability and Health as collaborating tool 103
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Health care professional working either in Orthopaedic/Surgical, Medical and Paediatric wards. ¿Full time health care professionals during the period of intervention and data collection. ¿Qualified health care professional. Health care professional with at least 6 moths of working experience in the above mentioned wards. Patients Folders: ¿Medical records of patients who have been admitted to the orthopedic/surgical, medical and paediatric wards for at least five days. ¿Medical records of patients who have been discharged. ¿Medical records of discharged patients in six months prior to the study. ¿Medical records of discharged patients during the six months after training. None 19 Year(s) 50 Year(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 12/02/2016 Rwanda National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O BOX 84 Kigali-Rwanda Cape Town +250 Rwanda
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 12/02/2015 University of Cape Town, Faculty of Health Sciences, Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Hospital, Observatory 7925 Cape Town South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of this study was the improved interprofessional practice within the district hospitals and comprehensiveness of the patients¿ records demonstrated by the score At baseline and after 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kiziguro None Gatsibo +250 Rwanda
Nemba Hospital None Gakenke +250 Rwanda
Byumba Hospital None Gicumbi +250 Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Rwanda Education Board Kigali Kigali +250 Rwanda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rwanda Education Board (REB) Kigali Kigali +250 Rwanda Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Jennifer Jelsma Groote Schuur Hospital, Observatory 7925 Cape Town South Africa
Jeanne Kagwiza Kigali Kigali +250 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jean Baptiste Sagahutu sghjea001@myuct.ac.za 0635476447 or +250788800152
City Postal code Country Position/Affiliation
Kigali +250 Rwanda Lecturer at University of Rwanda/ College of Medicine and Health Sciences
Role Name Email Phone Street address
Public Enquiries Jeanne Kagwiza Kagwiza jkagwiza@yahoo.fr +250788755364 Kigali
City Postal code Country Position/Affiliation
Kigali +250 Rwanda Acting Principal of College of Medicine and Health Sciences/Univerity of Rwanda
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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