TuberculosisNCT01690754
Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes
A study testing Interactive Reminders in people with Tuberculosis, run by Interactive Research and Development at 11 sites in Pakistan.
Trial summary
In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive Reminders is an interactive SMS reminder system to help patients remember to take their TB medication. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Interactive Reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,207 participants
- Where
- 11 sitesPakistan
- Study dates
- Mar 2011to Nov 2014
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New, smear-positive drug susceptible TB who have been on treatment for less than two weeks
- Access to a mobile phone (self-reported)
- Intending to reside in Karachi for the duration of their treatment
Who cannot join
- Patients who do not have regular access to a mobile phone
- Patients who have previously received TB treatment
- Patients who have another member in their household who is already a part of the study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Pakistan11 sites
Civil Hospital
Karachi
Indus Hospital
Karachi
Jinnah Postgraduate Medical Center
Karachi
Landhi Medical Complex
Karachi
Private GP clinics and Private labs partnering with Interactive Research and Devellopment
Karachi
Sindh Government Hospital - Liaqatabad
Karachi
Sindh Government Hospital - New Karachi
Karachi
Sindh Government Hospital - Qatar
Karachi
Sindh Government Hospital New Karachi Kaali Market
Karachi
UHC-New Karachi
Karachi
Urban Health Center - Landhi
Karachi
About this study
Official title: Monitoring Patient Compliance With Tuberculosis Treatment Regimens
In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive Reminders is an interactive SMS reminder system to help patients remember to take their TB medication. In this system, patients receive daily SMS reminders for the duration of their treatment at a pre-specified time, reminding them to take their medication. Patients are asked to reply back to the system, either through SMS or a missed call, with the time they took their medicine that day. If a response is not received within two hours, a second reminder is sent. If a response is still not received in a further two hours, a third and final reminder for the day is sent. Non-responsive patients are followed up with phone calls and a list of non-responsive patients is shared with clinics based on the parameters of non-responsiveness that they specify.
IRD seeks to determine the impact of this system on treatment outcomes and compliance to prescribed medication through administering a randomized control trial among newly diagnosed TB patients in Karachi, Pakistan.
- Conditions
- Tuberculosis
- Being tested
- Interactive Reminders
- Keywords
- SMS, tuberculosis, impact evaluation
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive RemindersOther
Daily SMS reminders sent to TB patients at a pre-specified time. They are asked to respond to the reminders. If a response is not received within two hours, they are sent another reminder for up to three per day.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This arm will receive the regular standard of care given by TB clinics. |
| Interactive Reminders | Experimental | Patients randomized to this arm will receive Interactive SMS reminders daily. Receives: Other: Interactive Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Outcomes
The investigators will compare clinically reported treatment outcomes between the intervention and control groups.
Measured: After 6 to 8 months of treatment
Secondary outcomes (4)
Physical fitness and mobility
The investigators will measure physical fitness and mobility through questionnaires conducted with patients during household visits each month that they are on treatment. The investigators are using two indices. The physical fitness index will record respondents ability to perform certain tasks. The mobility index will record the mobility of participants.
Measured: Monthly visits for 6 to 8 months of treatment
Psychological Impacts
In order to gauge the psychological impacts of the system, the investigators will be looking at participants' perceptions on the likelihood of being cured, how they feel on a given day using the pain scale, and how supported they feel. This data will be collected through questionnaires conducted at each monthly mid-line visit.
Measured: Monthly visits for 6 to 8 months of treatment
Self-reported medication adherence
Medication adherence will be measured through self-reports by participants on whether they took their TB medication in the past 24 hours. This data will be collected through monthly "surprise" visits to the participants' houses.
Measured: "Surprise" monthly visits during treatment
Sputum conversion
The investigators will look at sputum test results for patients at months 2, 5, and 6/7 of their treatment to compare when sputum conversion occurs between the intervention and control group at these three periods during their treatment.
Measured: At 1, 2, 5, and 6/7 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startMar 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interactive Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Shama Mohammed, Interactive Research and Development
- Investigators
- Rachel Glennerster, PhD., Principal investigator, Massachusetts Institute of TechnologyShama Mohammed, MPA/ID, Principal investigator, Interactive Research and DevelopmentAamir J. Khan, MD/PhD., Principal investigator, Interactive Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690754
- Sponsor's protocol ID
- IRD_IRB_2011_03_002
- Status last verified
- Mar 2015
- First submitted
- 13 Sep 2012
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mohammed S, Glennerster R, Khan AJ. Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial. PLoS One. 2016 Nov 1;11(11):e0162944. doi: 10.1371/journal.pone.0162944. eCollection 2016.
PubMed 27802283
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Patient Compliance With Tuberculosis Treatment Regimens
- ClinicalTrials.gov ID
- NCT01690754
- Acronym / sponsor ID
- IRD_IRB_2011_03_002
- Conditions
- Tuberculosis
- Keywords
- SMS, tuberculosis, impact evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,207 participants (actual)
- Lead sponsor
- Interactive Research and DevelopmentUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- Mar 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Sep 2012 (estimated)
- 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.
In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive Reminders is an interactive SMS reminder system to help patients remember to take their TB medication. In this system, patients receive daily SMS reminders for the duration of their treatment at a pre-specified time, reminding them to take their medication. Patients are asked to reply back to the system, either through SMS or a missed call, with the time they took their medicine that day. If a response is not received within two hours, a second reminder is sent. If a response is still not received in a further two hours, a third and final reminder for the day is sent. Non-responsive patients are followed up with phone calls and a list of non-responsive patients is shared with clinics based on the parameters of non-responsiveness that they specify.
IRD seeks to determine the impact of this system on treatment outcomes and compliance to prescribed medication through administering a randomized control trial among newly diagnosed TB patients in Karachi, Pakistan.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm will receive the regular standard of care given by TB clinics. |
| Interactive Reminders | Experimental | Other: Interactive RemindersPatients randomized to this arm will receive Interactive SMS reminders daily. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- New, smear-positive drug susceptible TB who have been on treatment for less than two weeks
- Access to a mobile phone (self-reported)
- Intending to reside in Karachi for the duration of their treatment
Key exclusion criteria (3 listed)
- Patients who do not have regular access to a mobile phone
- Patients who have previously received TB treatment
- Patients who have another member in their household who is already a part of the study
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 |
|---|---|---|
| Interactive RemindersDaily SMS reminders sent to TB patients at a pre-specified time. They are asked to respond to the reminders. If a response is not received within two hours, they are sent another reminder for up to three per day. | Other | Interactive Reminders |
Primary outcome
Treatment Outcomes
Time frame: After 6 to 8 months of treatment
The investigators will compare clinically reported treatment outcomes between the intervention and control groups.
4 secondary outcomes
Physical fitness and mobility
Time frame: Monthly visits for 6 to 8 months of treatment
Psychological Impacts
Time frame: Monthly visits for 6 to 8 months of treatment
Self-reported medication adherence
Time frame: "Surprise" monthly visits during treatment
Sputum conversion
Time frame: At 1, 2, 5, and 6/7 months of treatment
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 20 Mar 2015.
- Derived from this study: PubMed 27802283Mohammed S, Glennerster R, Khan AJ. Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial. PLoS One. 2016 Nov 1;11(11):e0162944. doi: 10.1371/journal.pone.0162944. eCollection 2016.
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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.
Rachel Glennerster, PhD. principal investigator
Massachusetts Institute of Technology
Shama Mohammed, MPA/ID principal investigator
Interactive Research and Development
Aamir J. Khan, MD/PhD. principal investigator
Interactive Research and Development
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Reminders in people with Tuberculosis, run by Interactive Research and Development at 11 sites in Pakistan.
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 3 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 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Pakistan. 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?
Treatment Outcomes (time frame: After 6 to 8 months of treatment). 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 NCT01690754, which also lists 1 linked publication.
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 20 Mar 2015.