Condition category
Not Applicable
Date applied
21/01/2014
Date assigned
13/02/2014
Last edited
08/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
very few low-income countries have complete vital registration systems to monitor adult mortality accurately. Instead, adult mortality is estimated from data collected during household-based surveys, by asking respondents about the survival of their siblings. These siblings' survival histories (SSH) are inexpensive to collect but are potentially affected by large errors. As a result, estimates of the level of adult mortality in low-income countries are frequently contested. In this project, we tested whether a new survey instrument helps improve the quality of data on siblings' survival collected during surveys.

Who can participate?
This study recruited participants who ever resided among the population of the Niakhar Health and demographic surveillance area in Senegal. Participants were aged 15-59 years old, and had at least one adult sibling. We recruited 824 participants among families with at least one adult death and 375 among families with only surviving members.

What does the study involve?
We interviewed participants with either the standard SSH questionnaire (the same questionnaire that is used in most national surveys), or a new questionnaire, which we call the siblings’ survival calendar (SSC). The questionnaire to which a participant was allocated was decided by a process called “randomisation”, equivalent to a coin toss. We then compared the answers provided by respondents according to the type of questionnaire they were interviewed with. In particular, we checked whether respondents interviewed with the SSC omitted fewer of their siblings and reported the ages and possible date of death of their siblings more accurately.

What are the possible benefits and risks of participating?
There are no direct benefits for the respondents. However, information gathered from the study respondents will help significantly improve the measurement of adult and maternal mortality in Senegal, and possibly in other low-income countries.
Risks associated with the study only involve possible discomforts felt by respondents when recalling deaths of siblings, as well as a potential breach of confidentiality if information collected during the study is accidentally disclosed to a third party.

Where is the study run from?
The study is run by Columbia University, the Institut National D’études démographiques (Paris, France), and the Institut de Recherche pour le Développement (Dakar, Sénégal).
Recruitment took place in the Niakhar area of Senegal (Fatick region).

When is the study starting and how long is it expected to run for?
Recruitment for the study lasted from January to March 2013. Participants were asked to take part in a single interview, which lasted 30-45 minutes. No follow-up was conducted.

Who is funding the study?
National Institutes of Health (NICHD, USA) and Agence Nationale de la Recherche (ANR, France).

Who is the main contact?
Stéphane Helleringer
sh2813@columbia.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephane Helleringer

ORCID ID

Contact details

60 Haven Avenue
Level B-2
New York
NY 10032
United States of America
-
sh2813@columbia.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R03HD071117

Study information

Scientific title

Improving adolescent and adult mortality data in developing countries: a block-randomised controlled trial

Acronym

Study hypothesis

We hypothesize that a new survey questionnaire, which incorporates recall cues and a life calendar approach, will significantly improve the quality of data on adult mortality collected during surveys in developing countries with limited vital registration systems.

Ethics approval

Columbia University Medical Center Institutional Review Board, 11/17/2011, Protocol ref.: IRB-AAAI9159
National Ethics Committee for Health Research in Sante (Comite National d'Ethique pour la Recherche en Sante) (Dakar, Senegal), 08/14/2012, Protocol ref.: SEN 12/11

Study design

Parallel arm block-randomised controlled trial of the SSC questionnaire

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Measurements of adult mortality during retrospective surveys

Intervention

Participants were randomized as follows. first, we drew a sample of potential participants from the list of individuals in the population rosters of the Niakhar HDSS who met eligibility requirements. Among these selected participants, randomization was then done using a random-number generator and was stratified by gender, age of the respondent and family composition. randomization was done in blocks of 10. Each participant then underwent one single interview with either the standard questionnaire (used in most demographic and health surveys) or our new siblings’ survival calendar. There was no follow-up, all study outcomes were measured durign this single interview.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Proportion of respondents who forget at least one of their adult siblings during the survey measured at baseline and there was no follow-up. Our study tested the efficacy of a new questionnaire in improving data quality collected during cross-sectional surveys.

Secondary outcome measures

Average error in reports of the:
1. Current age of live siblings
2. Age at death of deceased siblings
3. Number of years since the death of deceased siblings

Overall trial start date

15/01/2013

Overall trial end date

30/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Being aged 15-59 years old
2. Having ever resided in the Niakhar Health and Demographic Surveillance System (HDSS) area
3. Having at least one maternal sibling according to the Niakhar HDSS dataset.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

824 among families with at least one adult death + 375 among families with only surviving members

Participant exclusion criteria

Residing outside of Senegal or in areas of Senegal where the study team cannot visit a potential participant (e.g., regions distant from the capital).

Recruitment start date

15/01/2013

Recruitment end date

30/03/2013

Locations

Countries of recruitment

Senegal

Trial participating centre

60 Haven Avenue
New York
NY 10032
United States of America

Sponsor information

Organisation

National Institutes of Health (USA)

Sponsor details

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
31 Center Drive
Building 31
Room 2A32
Bethesda
MD 20892-2425
United States of America

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Institutes of Health

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Agence Nationale de la Recherche

Alternative name(s)

French National Research Agency, ANR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

France

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24866715

Publication citations

Additional files

Editorial Notes