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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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18 March 2024 |
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Main ID: |
ISRCTN84560580 |
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Date of registration:
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17/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The role of information in the uptake of preventative healthcare
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Scientific title:
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Information and the demand for preventative healthcare: a randomised controlled trial of improving household perceptions on the efficacy of DPT immunisation in Uttar Pradesh, India |
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Date of first enrolment:
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10/07/2015 |
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Target sample size:
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900 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN84560580 |
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Study type:
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Interventional |
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Study design:
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Randomized controlled trial design (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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India
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Timothy
Powell-Jackson |
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Address:
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15-17 Tavistock Place
WC1H 9SH
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Mother with a child aged 0-36 months living in the same household
2. Child has not received three doses of DPT vaccine
3. Mother gives consent to participate in the study
4. Mother intends to remain in the study area for the six months
Exclusion criteria: 1. Child of mother is not aged 0-36 months
2. Child of mother is not living in the same household
3. Child has received three doses of DPT vaccine
4. Mother does not give consent to participate in the study
5. Mother due to emigrate from the study area in the six months
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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The role of information in influencing household decisions to get their child vaccinated against tetanus
Not Applicable
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Intervention(s)
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Families will be individually randomised into three study arms. Mothers in the first treatment group will be given information on tetanus and benefits of vaccination framed in positive terms. The information script will describe the symptoms of tetanus, possible health consequences, the individual benefit of the combination vaccine in terms of mortality and morbidity gains, wider community benefits associated with herd immunity, and where the family can get the child vaccinated at what cost and up until what age. A second treatment group will provide essentially the same information on efficacy but framed in negative terms. The third arm acts as a control group with no information given to the mother.
Added 08/03/2018:
The trialists are doing a longer term follow-up study of the same study participants. A household survey will be administered at 30 months follow-up.
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Primary Outcome(s)
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Proportion of study children with three doses of DPT vaccine at endline as verified by the vaccination card or reported by the mother
Added 08/03/2018:
1. Proportion of (index) children with three doses of DPT vaccine at 30 months follow-up as verified by vaccination card or reported by the mother
2. Proportion of other children in the household under five years with three doses of DPT vaccine at 30 months follow-up as verified by vaccination card or reported by the mother
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Secondary Outcome(s)
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1. The proportion of children fully vaccinated (against tuberculosis, diphtheria, pertussis, tetanus, polio and measles)
2. An index of the mother’s knowledge of tetanus symptoms
3. An index of the mother’s perception of the efficacy of tetanus vaccination
Added 08/03/2018:
1. Proportion of children fully vaccinated at 30 months follow-up (against tuberculosis, diphtheria, pertussis, tetanus, and measles)
2. Proportion of other children in the household under five years fully vaccinated at 30 months follow-up (against tuberculosis, diphtheria, pertussis, tetanus, and measles)
3. Proportion of children vaccinated with measles vaccine at 30 months follow-up
4. Proportion of other children in the household under five years vaccinated with measles vaccine at 30 months follow-up
5. Proportion of children with suspected diarrhoea in the last four weeks at 30 months follow-up
6. Proportion of children with suspected pneumonia in the last four weeks at 30 months follow-up
7. Proportion of children with suspected diarrhoea in the last four weeks and correctly treated at 30 months follow-up
8. Proportion of children with suspected pneumonia in the last four weeks and correctly treated at 30 months follow-up
9. Mother’s knowledge of any symptom of tetanus at 30 months follow-up
10. Mother’s knowledge of any cause of tetanus at 30 months follow-up
11. Mother’s knowledge of any tetanus prevention method at 30 months follow-up
12. Mother’s perception of the efficacy of tetanus vaccination at 30 months follow-up
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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Merck Sharp & Dohme Corp (USA) through MSD for Mothers
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; 1. The Intervention Research Ethics Committee of the London School of Hygiene and Tropical Medicine in London, 16/12/2014, ref: 8778
2. The institutional review board of the Public HealthCare Society in New Delhi, 18/08/2014
3. The Intervention Research Ethics Committee of the London School of Hygiene and Tropical Medicine in London, amendment 13/11/2017, ref: 8778-1
4. The institutional review board of the Public HealthCare Society in New Delhi, amendment 24/09/2017
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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15/05/2018 |
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URL:
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