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.: PACTR201605001578237 Date of Registration: 11/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title DETERMINATION OF THE IMPACT OF REHABILITATION VILLAGES AS A SERVICE DELIVERY MODEL: A STUDY OF VIEWS AND EXPERIENCES OF ZIMBABWEAN CAREGIVERS OF CHILD
Official scientific title DETERMINATION OF THE IMPACT OF REHABILITATION VILLAGES AS A SERVICE DELIVERY MODEL: A PRAGMATIC QUASI-EXPERIMENTAL STUDY
Brief summary describing the background and objectives of the trial Cerebral palsy (CP) is the most common physical disabling paediatric neurological condition and it¿s envisaged as the prototype of childhood disability. Children with CP present with multiple impairments and functional deficits thus requiring lifetime assistance from caregivers in activities of daily living. Consequently, caregiving a child with CP may negatively affect the health and health related quality of life (HRQoL) of informal, primary caregivers. It thus becomes imperative to establish the normative HRQoL of Zimbabwean caregivers, develop context-specific and culturally acceptable tools for measuring the associated burden of care. Further, it¿s paramount to determine the efficacy of models of service delivery which aim at improving the HRQoL of caregivers in addition to provision of therapy to children with CP.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Musculoskeletal Diseases,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/06/2016
Actual trial start date
Anticipated date of last follow up 31/08/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 226
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Non-randomised N/A Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group rehabilitation village treatment once every three months 9 months group therapy and individual therapy sessions 113
Control Group usual care variable 9 months individaul treatment sessions 113
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for children ¿ Diagnosis of CP according to the patient notes ¿ Ages 0 to 12 years - The GMFM has good content and face validity for children in the age range 0.5 to 13 years ¿ Absence of planned surgery , of significant medical and nutritional problems or other clinical factors that might bias rehabilitation program Inclusion criterion for caregivers ¿ Residing in districts under investigation for follow up purposes ¿ living with the child Exclusion criteria for children ¿ Presence of other neurological disability e.g. Spinal Bifida ¿ Clients also receiving other forms of therapeutic interventions such as private physiotherapy Exclusion criterion for caregivers ¿ providing care for an elderly, chronically ill or disabled relative ¿ having a history of chronic illness, such as diabetes, cardiovascular disease among others ¿ having another child at home with special health care needs 0 Year(s) 12 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
No 26/02/2016 University of cape town, Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
room E52-24 OLD MAIN BUILDING GROOTE SCHUUR HOSPITAL Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome caregiver burden baseline, 3, 6 and 9 months
Secondary Outcome quality of life baseline, 3, 6 and 9 months
Secondary Outcome social support baseline, 3, 6 and 9 months
Secondary Outcome psychiatry morbidity baseline, 3, 6 and 9 months
Secondary Outcome satisfaction with services 9 months
Secondary Outcome motor function baseline, 3, 6 and 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
harare central hospital ST 14 Southerton harare 0263 Zimbabwe
mt darwin district hospital 1 mt darwin mt darwin 00263 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
NONE
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor University of cape town Division of Physiotherapy Department of Health and Rehabilitation Sciences Faculty of Health Sciences University of Cape Town. Anzio Road Observatory, Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
NONE
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jermaine Dambi jermainedambi@gmail.com +263773444911 9 Chigwell Avenue
City Postal code Country Position/Affiliation
Harare 00263 Zimbabwe lecturer
Role Name Email Phone Street address
Public Enquiries Jermaine Dambi jermainedambi@gmail.com +263773444911 9 Chigwell Avenue , Greencroft
City Postal code Country Position/Affiliation
Harare 00263 Zimbabwe Lecturer
Role Name Email Phone Street address
Scientific Enquiries Jermaine Dambi jermainedambi@gmail.com +263773444911 9 chigwell greencroft
City Postal code Country Position/Affiliation
Harare 00263 Zimbabwe lecturer
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