Surveys and QuestionnairesNCT04506931
Comparison of SMS, IVR, and CATI Surveys in Colombia
A study testing SMS Survey, IVR Survey and CATI Survey in people with Surveys and Questionnaires and Noncommunicable Diseases, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Colombia.
Trial summary
The objective of the study is to adapt and assess the feasibility, quality, and validity of short message service or 'text message' (SMS), interactive voice response (IVR), and computer assisted telephone interviews (CATI) for collecting information on noncommunicable disease (NCD) risk factors Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surveys and Questionnaires, Noncommunicable Diseases
- What is being tested?
- SMS Survey, IVR Survey and CATI Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,676 participants
- Where
- 1 siteColombia
- Study dates
- 15 Jan 2021to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Access to a mobile phone
- Greater or equal to 18 years of age
- In Colombia, conversant in the Spanish language
Who cannot join
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Short Message Service (SMS), Interactive Voice Response (IVR), and Computer Assisted Telephone Interview (CATI) Mobile Phone Surveys for Non-communicable Disease Risk Factor Surveillance in Colombia
The objective of the study is to adapt and assess the feasibility, quality, and validity of short message service or 'text message' (SMS), interactive voice response (IVR), and computer assisted telephone interviews (CATI) for collecting information on noncommunicable disease (NCD) risk factors
Read the detailed description
Using random digit dialing (RDD) sampling technique, RDD participants will be randomized to one of the three arms: 1) SMS or 2) IVR or 3) CATI. Participants in the first study arm will receive an SMS survey. Participants in the second study arm will receive a IVR survey. Participants in the third study arm will receive a CATI survey. The IVR, SMS and CATI questionnaires contain a set of demographic questions and one NCD module (alcohol, or tobacco, or diet, or physical activity, or blood pressure and diabetes). The investigators will examine contact, response, refusal and cooperation rates and demographic representativeness by each study arm.
- Being tested
- SMS Survey, IVR Survey, CATI Survey
- Keywords
- mobile phone surveys, interactive voice response, computer assisted telephone interview, short message service, non-communicable diseases
- Medical subject headings
- Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS SurveyOther
Participants will receive a SMS survey
IVR SurveyOther
Participants will receive an IVR survey
CATI SurveyOther
Participants will receive a CATI survey
| Study group | Role | What they receive |
|---|---|---|
| Short Message Service (SMS) survey | Experimental | Participants will receive an SMS survey Receives: Other: SMS Survey |
| Interactive Voice Response (IVR) survey | Experimental | Participants will receive an IVR survey Receives: Other: IVR Survey |
| Computer Assisted Telephone Interviews (CATI) survey | Experimental | Participants will receive a CATI survey Receives: Other: CATI Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cooperation Rate #1
As defined by American Association for Public Opinion Research, cooperation rate is defined as I/(I+P+R) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, and R is the number of participants with refusals and breakoffs.
Measured: Through study completion, an average of one month
Response Rate #4
As defined by American Association for Public Opinion Research, response rate is defined as (I+P)/(I+P+R+eU) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with refusals and breakoffs, and eU is the estimated eligible proportion of unknowns
Measured: Through study completion, an average of one month
Secondary outcomes (2)
Refusal Rate #2
As defined by American Association for Public Opinion Research, refusal rate is defined as (R)/(I+P+R+eU) where R is the number of participants with refusals and breakoffs, I is the number of participants with complete interviews, P is the number of participants with partial interviews, and eU is the estimated eligible proportion of unknowns
Measured: Through study completion, an average of one month
Contact Rate #2
As defined by American Association for Public Opinion Research, contact rate is defined as (I+P+R)/(I+P+R+eU) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with refusals and breakoffs, and eU is the estimated eligible proportion of unknowns
Measured: Through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start15 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surveys and QuestionnairesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to one of three mobile phone survey modalities: 1) SMS; 2) IVR; 3) CATI.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Dustin Gibson, PhD, Principal investigator, Johns Hopkins University Bloomberg School of Public HealthAngelica T Quinterro, PhD, MD, MSc, Principal investigator, Pontificia Universidad Javeriana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506931
- Sponsor's protocol ID
- 00007318 - xyz
- Status last verified
- Apr 2022
- First submitted
- 7 Aug 2020
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibson DG, Pariyo GW, Wosu AC, Greenleaf AR, Ali J, Ahmed S, Labrique AB, Islam K, Masanja H, Rutebemberwa E, Hyder AA. Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol. JMIR Res Protoc. 2017 May 5;6(5):e81. doi: 10.2196/resprot.7534.
PubMed 28476729Gibson DG, Pereira A, Farrenkopf BA, Labrique AB, Pariyo GW, Hyder AA. Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review. J Med Internet Res. 2017 May 5;19(5):e139. doi: 10.2196/jmir.7428.
PubMed 28476725Gibson DG, Farrenkopf BA, Pereira A, Labrique AB, Pariyo GW. The Development of an Interactive Voice Response Survey for Noncommunicable Disease Risk Factor Estimation: Technical Assessment and Cognitive Testing. J Med Internet Res. 2017 May 5;19(5):e112. doi: 10.2196/jmir.7340.
PubMed 28476724Hyder AA, Wosu AC, Gibson DG, Labrique AB, Ali J, Pariyo GW. Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda. J Med Internet Res. 2017 May 5;19(5):e133. doi: 10.2196/jmir.7246.
PubMed 28476722
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short Message Service (SMS), Interactive Voice Response (IVR), and Computer Assisted Telephone Interview (CATI) Mobile Phone Surveys for Non-communicable Disease Risk Factor Surveillance in Colombia
- ClinicalTrials.gov ID
- NCT04506931
- Acronym / sponsor ID
- 00007318 - xyz
- Keywords
- mobile phone surveys, interactive voice response, computer assisted telephone interview, short message service, non-communicable diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,676 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to adapt and assess the feasibility, quality, and validity of short message service or 'text message' (SMS), interactive voice response (IVR), and computer assisted telephone interviews (CATI) for collecting information on noncommunicable disease (NCD) risk factors
Detailed description
Using random digit dialing (RDD) sampling technique, RDD participants will be randomized to one of the three arms: 1) SMS or 2) IVR or 3) CATI. Participants in the first study arm will receive an SMS survey. Participants in the second study arm will receive a IVR survey. Participants in the third study arm will receive a CATI survey. The IVR, SMS and CATI questionnaires contain a set of demographic questions and one NCD module (alcohol, or tobacco, or diet, or physical activity, or blood pressure and diabetes). The investigators will examine contact, response, refusal and cooperation rates and demographic representativeness by each study arm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomized to one of three mobile phone survey modalities: 1) SMS; 2) IVR; 3) CATI.
| Arm | Type | Receives |
|---|---|---|
| Short Message Service (SMS) survey | Experimental | Other: SMS SurveyParticipants will receive an SMS survey |
| Interactive Voice Response (IVR) survey | Experimental | Other: IVR SurveyParticipants will receive an IVR survey |
| Computer Assisted Telephone Interviews (CATI) survey | Experimental | Other: CATI SurveyParticipants will receive a CATI survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Access to a mobile phone
- Greater or equal to 18 years of age
- In Colombia, conversant in the Spanish language
Key exclusion criteria (1 listed)
- Less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS SurveyParticipants will receive a SMS survey | Other | Short Message Service (SMS) survey |
| IVR SurveyParticipants will receive an IVR survey | Other | Interactive Voice Response (IVR) survey |
| CATI SurveyParticipants will receive a CATI survey | Other | Computer Assisted Telephone Interviews (CATI) survey |
Primary outcome
Cooperation Rate #1
Time frame: Through study completion, an average of one month
As defined by American Association for Public Opinion Research, cooperation rate is defined as I/(I+P+R) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, and R is the number of participants with refusals and breakoffs.
Response Rate #4
Time frame: Through study completion, an average of one month
As defined by American Association for Public Opinion Research, response rate is defined as (I+P)/(I+P+R+eU) where I is the number of participants with complete interviews, P is the number of participants with partial interviews, R is the number of participants with refusals and breakoffs, and eU is the estimated eligible proportion of unknowns
2 secondary outcomes
Refusal Rate #2
Time frame: Through study completion, an average of one month
Contact Rate #2
Time frame: Through study completion, an average of one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Background: PubMed 28476729Gibson DG, Pariyo GW, Wosu AC, Greenleaf AR, Ali J, Ahmed S, Labrique AB, Islam K, Masanja H, Rutebemberwa E, Hyder AA. Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol. JMIR Res Protoc. 2017 May 5;6(5):e81. doi: 10.2196/resprot.7534.
- Background: PubMed 28476725Gibson DG, Pereira A, Farrenkopf BA, Labrique AB, Pariyo GW, Hyder AA. Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review. J Med Internet Res. 2017 May 5;19(5):e139. doi: 10.2196/jmir.7428.
- Background: PubMed 28476724Gibson DG, Farrenkopf BA, Pereira A, Labrique AB, Pariyo GW. The Development of an Interactive Voice Response Survey for Noncommunicable Disease Risk Factor Estimation: Technical Assessment and Cognitive Testing. J Med Internet Res. 2017 May 5;19(5):e112. doi: 10.2196/jmir.7340.
- Background: PubMed 28476722Hyder AA, Wosu AC, Gibson DG, Labrique AB, Ali J, Pariyo GW. Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda. J Med Internet Res. 2017 May 5;19(5):e133. doi: 10.2196/jmir.7246.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dustin Gibson, PhD principal investigator
Johns Hopkins University Bloomberg School of Public Health
Angelica T Quinterro, PhD, MD, MSc principal investigator
Pontificia Universidad Javeriana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Survey, IVR Survey and CATI Survey in people with Surveys and Questionnaires and Noncommunicable Diseases, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cooperation Rate #1 (time frame: Through study completion, an average of one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04506931, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.