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.: PACTR202301560735856 Date of Approval: 17/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title MOBILE PHONE CALL: INTERVENTION TO IMPROVE ORAL REHYDRATION SALT AND ZINC ADHERENCE FOR ACUTE DIARRHOEA IN CHILDREN SPECIALIST HOSPITAL, ILORIN
Official scientific title MOBILE PHONE CALL: INTERVENTION TO IMPROVE ORAL REHYDRATION SALT AND ZINC ADHERENCE FOR ACUTE DIARRHOEA IN CHILDREN SPECIALIST HOSPITAL, ILORIN
Brief summary describing the background and objectives of the trial Presumably, mobile phone call reminders improve the use of ORS and zinc for treating diarrhoea; however, empirical evidence is scarce. The purpose of this work is to evaluate whether phone call reminders can enhance adherence to ORS and zinc therapy or not.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Diarrhoea
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2019
Actual trial start date 01/01/2019
Anticipated date of last follow up 30/04/2019
Actual Last follow-up date 31/05/2019
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 400
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ERC PIN 2013 05 0603 University of Ilorin Teaching Hospital
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
Control Group ORS and zinc treatment for childhood diarrhoea ORS was given according to the number of diarrhoea episodes and the child's weight. A zinc tablet was given 20mg daily. Ten days The mothers received a brief health talk on diarrhoea in either English or Yoruba for an average of five minutes. The days of therapy numbered one to eleven: Day one was the first day of contact with the research team, day ten was the last day of zinc therapy, and the follow-up visit was done on day 11. Eight sachets (one liter) of ORS were given to the mother, a packet containing ten 20mg zinc tablets, and a pictorial diary. They were taught and advised to tick whenever a child passes loose stool, whenever the child receives ORS after a loose stool, and after the zinc tablet is administered. Subsequently, they were instructed to return with their children on day 11 with the used sachets of ORS, the zinc packet, and the pictorial diary. After this, the mother picks a small envelope from a sealed bag, and the number in it is noted. This number was checked for its corresponding "label"- either "A" or "B" among 400 randomly generated numbers. Then, the subjects whose corresponding label is "B" were assigned to the control arm. A convenient time at which calls could be made was agreed upon and noted. Phone calls were made ONLY on day 10 of therapy to remind them of their next appointment. The call was successful when the mother or caregiver answered the phone, and the information was delivered. A maximum of three attempts was made per call session, and if the phone was not answered, three additional attempts were made to reach the subject on the alternative number available. If the mother/caregiver was still not reached on the alternative number, the same process was repeated an hour after until they could be reached. Mothers who did not have mobile phones were called on the alternative number they provided. At follow-up, the number of times that ORS was given after a loose stool and the total number of zinc tablets were counted and noted. 200 Active-Treatment of Control Group
Experimental Group ORS and zinc treatment for childhood diarrhoea. ORS was given according to the number of diarrhoea episodes and the child's weight. A 20mg zinc tablet was given daily. Ten days The mothers received a brief health talk on diarrhoea in either English or Yoruba for an average of five minutes. The days of therapy numbered one to eleven: Day one was the first day of contact with the research team, day ten was the last day of zinc therapy, and the follow-up visit was done on day 11. Eight sachets (one liter) of ORS were given to the mother, a packet containing ten 20mg zinc tablets, and a pictorial diary. They were taught and advised to tick whenever a child passes loose stool, whenever the child receives ORS after a loose stool, and after a zinc tablet is administered. Subsequently, they were instructed to return with their children on day 11 with the used sachets of ORS, the zinc packet, and the pictorial diary. After this, the mother picks a small envelope from a sealed bag, and the number in it is noted. This number was checked for its corresponding "label"- either "A" or "B" among 400 randomly generated numbers. Then, the subjects whose corresponding label is "A" were assigned to the intervention arm. A convenient time at which calls could be made was agreed upon and noted. The phone call was done using a pre-written script to ensure information uniformity. The intervention through phone calls was made on zinc therapy's days 3 and 7. The information provided during these phone sessions was similar to that given to subjects in both groups (control and intervention) at the initial visit. The researcher filled out a form noting the phone call duration. Additional phone calls were made on day 10 of therapy to remind them of their next appointment. The call was successful when the mother or caregiver answered the phone, and the information was delivered. At follow-up, the number of times that ORS was given after a loose stool and the total number of zinc tablets were counted and noted. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged six to fifty-nine months who presented with acute diarrhoea, defined as the presence of at least three abnormally loose or watery stools in the preceding 24 hours with onset less than 14 days. Mother/caregiver who owned a mobile phone or had access to one. Mother/caregiver who gave informed consent. Children with acute diarrhoea who had been on zinc and/or ORS before presentation at the hospital. Children who had diarrhoea that was associated with surgical complications like intussusception. Children with a diarrhoeal disease that required admission into the hospital, including those with severe dehydration and repeated vomiting. Mothers/caregivers who were visiting and were staying in Ilorin for less than ten days and thereby could not return to the hospital for the scheduled follow-up appointment. Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(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 19/02/2019 University of Ilorin Teaching Hospital Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road, Oke-Ose Ilorin 240243 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Independent adherence to ORS and zinc. Full adherence to ORS means that the solution is given after every bowel motion until the diarrhoea illness stops, while full adherence to zinc means that the child had a tablet of zinc daily for ten days. Partial adherence means that these were not done. The independent ORS adherence score (%) was calculated as the percentage of times ORS was administered to the child after each diarrhoeal episode. In contrast, the independent zinc adherence score (%) was calculated as the percentage of zinc tablets administered to the child out of the ten tablets. At follow-up
Secondary Outcome Combined adherence to ORS and zinc. Full adherence means that the child gets ORS after every bowel motion until the diarrhoea illness stops and the ten tablets of zinc. Partial adherence means that these were not done. The combined adherence score (%) was calculated using a composite index developed by attributing a weight of 0.5 to each ORS and zinc adherence index.. At follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Children Specialist Hospital Center Igboro Ilorin Metro, Kwara State, Nigeria Ilorin 240281 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Titilayo Kayode Alabi Plot 704, Sentinel crescent, Durunmi 1 Abuja 900104 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Titilayo Kayode Alabi Plot 704, Sentinel crescent, Durunmi 1 Abuja 900104 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Titilayo Kayode Alabi omomolawa2@gmail.com +2348034688722 Plot 704, Sentinel crescent, Durunmi 1
City Postal code Country Position/Affiliation
Abuja 900104 Nigeria Consultant Paediatrician Angelic Care Hospital and Maternity Abuja
Role Name Email Phone Street address
Public Enquiries Kayode Alabi drkayodealabi1@gmail.com +2348060223572 Tafawa Balewa Way, Area 8, Garki
City Postal code Country Position/Affiliation
Abuja 900243 Nigeria Consultant Paediatrician Garki Hospital Abuja
Role Name Email Phone Street address
Scientific Enquiries Rasheedat Ibraheem rasheedahbidmus@yahoo.com +2348033704168 Old Jebba Road, Oke-Ose
City Postal code Country Position/Affiliation
Ilorin 240243 Nigeria Consultant Paediatrician University of Ilorin Teaching Hospital Ilorin
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data will be available. The text, tables, figures, and appendices will be available after participant deidentification. In addition, the study protocol, data analysis plan, and informed consent form will be available. This information will be provided within nine months and up to 24 months after the article has been published. Only researchers with methodologically sound proposals to achieve similar objectives can access the information. The proposal should be directed to the principal investigator at omomolawa2@gmail.com. Then, the requestors can access the data for 24 months after signing a data access agreement form. The data will be communicated by mail @ omomolawa2@gmail.com. Informed Consent Form,Statistical Analysis Plan,Study Protocol This information will be provided within nine months and up to 24 months after the article has been published. Only researchers with methodologically sound proposals to achieve similar objectives can access the information. The proposal should be directed to the principal investigator at omomolawa2@gmail.com. Then, the requestors can access the data for 24 months after signing a data access agreement form.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
omomolawa2@gmail.com Yes 27/12/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 27/12/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks not applicable
Changes to trial information