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.: PACTR201702002061736 Date of Approval: 22/02/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Targeted Health Education on Asthma Control among Children attending Clinics at Moi Teaching and Referral Hospital, Kenya
Official scientific title Impact of Targeted Health Education on Asthma Control among Children attending Clinics at Moi Teaching and Referral Hospital, Kenya A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Asthma being a chronic disease requires that for children to have good quality of life, the control of symptoms has to be good. In developing countries including Kenya, many children continue to visit hospitals with acute symptoms of asthma, which is a pointer to poor control. For optimal self-management of the disease patients and their parents should be given health education. The evidence of implementation of such asthma health education is lacking in our setup.Further, it is imprecise on how much adaptation of international health education guidelines exist to make them effective in poor resource set up. Identifying knowledge gaps in asthma self-management and the effect of targeted health education on asthma control will be important in determining optimal care at a national referral hospital without a specialized asthma clinic. Objectives: To determine the impact of targeted health education on the level of control among children with asthma attending clinics at Moi Teaching and Referral Hospital, Western Kenya
Type of trial RCT
Acronym (If the trial has an acronym then please provide) THEAC
Disease(s) or condition(s) being studied Asthma,Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 29/03/2017
Actual trial start date
Anticipated date of last follow up 29/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 166
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
0001680 Instutional Research and Ethics Committee- Moi Teaching & Referral Hospital and Moi University
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 Once these baseline information has been collected, at least 166 children-caretaker pairs shall be randomized into either intervention or control groups without reference to their baseline characteristics. Randomization shall be by computer software based on hospital patient identification numbers. The computer software shall be programmed to give two sets of numbers with labels of control and intervention. The randomization shall be done at the end of the screening once all the participants to be in the study have been identified. This shall ensure that allocation of participants to either group is not predictable. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Targeted Health Education Taped Video clips 15min each, repeated twice in each session, given twice amonth apart 6 month The intervention group (the parents/caretakers of children with asthma) shall receive targeted education material, adopted from the Global Initiative on Asthma guideline(GINA, 2015a) as well the national guidelines on treatment of asthma(Division of Leprosy, 2011),local adaptation shall be done with the help of the baseline data. 83
Control Group Routine Care None None The control group shall continue to have their routine care. Routine care for asthmatic children at MTRH involves the child with his/her parent/caretaker being seen by the clinician/doctor who provides the appropriate treatment and counsels them as appropriate. No additional health education is offered to them after the consultation. 83
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Children aged between 6-11years and having a parent/caretakers ¿ Meeting criteria for diagnosis of asthma using ISAAC screening questionnaire ¿ Parental/caretakers consent ¿ Children who are unstable or very sick (requiring urgent resuscitation measures such as oxygen, urgent rehydration, anticonvulsants) and succumb to illness within 24 hours of screening. ¿ Children with serious chronic comorbidities,for example, Chronic Heart Failure. ¿ Children who will not be in western Kenya for the next 6months after recruitment. 6 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
Yes 27/07/2016 Moi Teaching & Referral Hospital and Moi University School of Medicine
Ethics Committee Address
Street address City Postal code Country
Nandi Road Eldoret 30100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome This shall be the level of asthma control. It shall be measured as the proportion with either good or poor control in the intervention and control arms. At Baseline After 6months of follow up
Secondary Outcome The secondary outcome measures shall be from the baseline study and shall include factors associated with asthma control, knowledge gaps on childhood asthma as well as coming up with educational tool. At Baseline for all except Educational tool at baseline and closure of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Moi Teaching and Referral Hospital Nandi Road Eldoret 30100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Jomo Kenyatta University of Agriculutre and Technology Thika Superhighway- Juja Nairobi 00200 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Justus Maingi Simba (Individual) Thika Superhighway- Juja Nairobi 00200 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Dr. Yeri Kombe KNH-Hospital Road Nairobi Kenya
Prof. Rebecca Waihenya Thika Superhighway-Juja Nairobi 00200 Kenya
Dr. Irene Marete Nandi Road Eldoret 30100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Justus Maingi Simba maingij@gmail.com +254723114529 Thika SuperHighway-Juja
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya PhD Candidate, JKUAt & Lecturer, Child Health & Paediatrics, JKUAT
Role Name Email Phone Street address
Public Enquiries Justus Maingi Simba maingij@gmail.com +254723114529 Thika SuperHighway-Juja
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya PhD Candidate, JKUAt & Lecturer, Child Health & Paediatrics, JKUAT
Role Name Email Phone Street address
Scientific Enquiries Justus Maingi Simba maingij@gmail.com +254723114529 Thika SuperHighway-Juja
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya PhD Candidate, JKUAt & Lecturer, Child Health & Paediatrics, JKUAT
REPORTING
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