ISRCTN ISRCTN06849961
DOI https://doi.org/10.1186/ISRCTN06849961
Protocol serial number R03HD071117
Sponsor National Institutes of Health (USA)
Funders National Institutes of Health, Agence Nationale de la Recherche
Submission date
21/01/2014
Registration date
13/02/2014
Last edited
08/01/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Stephane Helleringer
Scientific

60 Haven Avenue
Level B-2
New York
NY 10032
United States of America

Email sh2813@columbia.edu

Study information

Primary study designInterventional
Study designParallel arm block-randomised controlled trial of the SSC questionnaire
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleImproving adolescent and adult mortality data in developing countries: a block-randomised controlled trial
Study objectivesWe 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(s)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
Health condition(s) or problem(s) studiedMeasurements of adult mortality during retrospective surveys
InterventionParticipants 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 typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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

Completion date30/03/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration1199
Key inclusion criteria1. 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.
Key exclusion criteriaResiding outside of Senegal or in areas of Senegal where the study team cannot visit a potential participant (e.g., regions distant from the capital).
Date of first enrolment15/01/2013
Date of final enrolment30/03/2013

Locations

Countries of recruitment

  • Senegal
  • United States of America

Study participating centre

60 Haven Avenue
New York
NY 10032
United States of America

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 27/05/2014 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes