MalariaNCT02645513
Text Message Reminders to Health Workers on Malaria, Pneumonia, and Diarrhea Case Management in Malawi
A study testing Malaria text message reminders to health workers and Malaria, pneumonia, and diarrhea text message reminders to health workers in people with Malaria and Pneumonia, run by Centers for Disease Control and Prevention.
Trial summary
The purpose of this study is to assess whether twice-daily text message reminders over a six-month period to health workers in Malawi about diagnosis and treatment of malaria, pneumonia, and diarrhea improve case management of these diseases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Malaria text message reminders to health workers and Malaria, pneumonia, and diarrhea text message reminders to health workers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For health workers to receive text messages: Providing outpatient care or dispensing drugs at health facility randomized to one of two intervention arms.
- For health workers to be interviewed during baseline, endline, and follow-up surveys: working in the outpatient department sampled by the team during their visit.
- For patients to be interviewed during baseline, endline, and follow-up surveys: visiting facility to see a clinician for the first time for current illness
Who cannot join
None listed.
About this study
Official title: The Effect of Mobile Phone Text Message Reminders on Health Workers' Adherence to Malaria and Other Disease Case Management Guidelines in Malawi
The purpose of this study is to assess whether twice-daily text message reminders over a six-month period to health workers in Malawi about diagnosis and treatment of malaria, pneumonia, and diarrhea improve case management of these diseases.
Read the detailed description
Background Mobile health, or m-health includes the use of portable devices, such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices to support medical and public health practice. Mobile phones are widespread in Asia and Africa, and dissemination of health-related messages via mobile phones is an inexpensive way to reach geographically dispersed recipients. Evidence from developing countries, is scarce, particularly for improving health service delivery. Only one rigorously designed study, a randomized controlled trial in Kenya, assessed the use of mobile phone text messaging to improve health worker case management practices, showing that sending daily text message reminders to health workers over six months led to a 24-percentage-point improvement in correct management of uncomplicated malaria.
Malaria is endemic throughout Malawi and poses a significant burden for the health system. Malawi changed its malaria case management guidelines in 2011 to require diagnostic confirmation with microscopy or a malaria rapid diagnostic test (RDT) prior to treatment. A health facility survey in 2011 prior to the rollout of RDTs found that only 67% of patients with malaria were correctly treated, primarily due to a missed diagnosis of malaria. Although more recent assessments are lacking, it is likely that Malawi faces similar problems documented in other sub-Saharan African countries: non-systematic diagnostic testing of febrile patients for malaria, poor adherence to negative test results, failure to administer the first dose of antimalarial therapy during the consultation, and gaps in patient counseling. Furthermore, additional assessments have pointed to deficiencies in quality of care for other common illnesses in Malawi, such as pneumonia and diarrhea, which are similar to some of the widespread quality problems found in other developing countries.
Study design and objectives
This study is a trial of text message reminders to health workers in Malawi to improve case management of malaria and other common illnesses. The study will employ a cluster-randomized, controlled trial design with pre- and post-intervention measures, with health facilities as the cluster and unit of randomization. In several districts of Malawi, health facilities will be randomized to one of three arms:
- Text messages to health facility-based health workers on the correct management of malaria (patients of all ages)
- Text messages to health facility-based health workers on the correct management of malaria (patients of all ages) and other common illnesses, per Integrated Management of Childhood Illness guidelines (patients < 5 years)
- Control health facilities where health workers receive no study intervention (only routine supervision and supports from supervisors and district health management team, which will occur in text message arms as well)
Justification
This study will add to the small but growing body of literature on the potential for cell phones and text messages to improve malaria case management in different settings. In addition to providing evidence from a rigorously designed study on the effectiveness of text message reminders to health workers to improve malaria case management, this proposed study expands on the promising initial evidence base in the following ways:
- Assesses the effectiveness of text message reminders in a setting with malaria diagnostic testing
- Expands the intervention to include patients of all ages, not just children < 5 years
- Includes messages on common non-malarial illnesses, including pneumonia and diarrhea
Methodology All health workers providing clinical care or working in the pharmacy dispensing drugs at facilities randomized to arms 1 or 2 will receive text messages. Before the intervention, data collection via a cross-sectional health facility survey will occur in the three study arms and will include patient exit interviews with a focused history, physical examination, and blood smear; health worker interviews; and a brief facility assessment. Results from this survey will be used to measure the baseline levels of case-management quality for malaria and other diseases and to pinpoint performance deficiencies to target with the text message intervention. Once preliminary baseline results are available, a workshop will be held with key stakeholders, including National Malaria Control Programme staff, researchers, technology specialists, health education specialists, and health workers, to discuss the results and design an appropriate intervention strategy, including message content and timing.
Text message reminders on case management of malaria (arm 1) and of malaria and other common illnesses (arm 2) will be sent to health workers twice a day in the intervention groups for six months. At the end of the six-month text message intervention, approximately one year after the baseline survey, follow-up data will be collected with another cross-sectional health facility survey. At this time, in-depth interviews will also be conducted with selected health workers in intervention facilities to better understand their reactions to the text messages and to help determine mechanisms of action of the text message reminders. A second follow-up health facility survey will be conducted six months after the end of the intervention to assess the extent that changes in performance are maintained over time. Cost data on the intervention will also be collected for a cost-effectiveness analysis.
- Being tested
- Malaria text message reminders to health workers, Malaria, pneumonia, and diarrhea text message reminders to health workers, Control
- Keywords
- mHealth, text message, case management
- Medical subject headings
- Malaria, Pneumonia, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malaria text message reminders to health workersBehavioural
Text message reminders contain key details from national case management guidelines on diagnosis and treatment of malaria
Malaria, pneumonia, and diarrhea text message reminders to health workersBehavioural
Text message reminders contain key details from national case management guidelines on diagnosis and treatment of malaria, pneumonia, and diarrhea
ControlBehavioural
No text message reminders
| Study group | Role | What they receive |
|---|---|---|
| Malaria-only text messages | Experimental | Health workers at facilities in this arm receive twice-daily text message reminders for six months on key reminders related to malaria diagnosis and treatment. Receives: Behavioral: Malaria text message reminders to health workers |
| Malaria, pneumonia, and diarrhea messages | Experimental | Health workers at facilities in this arm receive twice-daily text message reminders for six months on key reminders related to diagnosis and treatment of malaria, pneumonia, and diarrhea Receives: Behavioral: Malaria, pneumonia, and diarrhea text message reminders to health workers |
| Control | Placebo comparator | No text message reminders to health workers, just the usual health system supports. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire measurement of diagnosis and treatment of malaria among outpatients
Patient exit interviews will be used to assess: 1) whether all suspect malaria patients are tested with a malaria diagnostic test; 2) whether patients with a positive test are prescribed the first- or second-line antimalarial; and 3) whether dosing of antimalarials are correct.
Measured: 12 months after end of text messages
Secondary outcomes (2)
Questionnaire measurement of diagnosis and treatment of pneumonia among outpatients
Patient exit interviews will be used to assess whether patients with surveyor-assessed pneumonia are prescribed the correct first-line antibiotic by health workers
Measured: 12 months after end of text messages
Questionnaire measurement of diagnosis and treatment of diarrhea among outpatients
Patient exit interviews will be used to assess whether patients with surveyor-assessed diarrhea are prescribed the first-line diarrhea treatment by health workers.
Measured: 12 months after end of text messages
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Malaria Alert Centre
- Responsible party
- Principal investigator, Laura Steinhardt, MPH, PhD, Centers for Disease Control and Prevention
- Investigators
- Don Mathanga, MD, PhD, Principal investigator, Malaria Alert Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645513
- Sponsor's protocol ID
- 6550
- Status last verified
- Dec 2017
- First submitted
- 30 Dec 2015
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zurovac D, Sudoi RK, Akhwale WS, Ndiritu M, Hamer DH, Rowe AK, Snow RW. The effect of mobile phone text-message reminders on Kenyan health workers' adherence to malaria treatment guidelines: a cluster randomised trial. Lancet. 2011 Aug 27;378(9793):795-803. doi: 10.1016/S0140-6736(11)60783-6. Epub 2011 Aug 3.
PubMed 21820166Steinhardt LC, Mathanga DP, Mwandama D, Nsona H, Moyo D, Gumbo A, Kobayashi M, Namuyinga R, Shah MP, Bauleni A, Troell P, Zurovac D, Rowe AK. The Effect of Text Message Reminders to Health Workers on Quality of Care for Malaria, Pneumonia, and Diarrhea in Malawi: A Cluster-Randomized, Controlled Trial. Am J Trop Med Hyg. 2019 Feb;100(2):460-469. doi: 10.4269/ajtmh.18-0529.
PubMed 30628566
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Phone Text Message Reminders on Health Workers' Adherence to Malaria and Other Disease Case Management Guidelines in Malawi
- ClinicalTrials.gov ID
- NCT02645513
- Acronym / sponsor ID
- 6550
- Keywords
- mHealth, text message, case management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Malaria Alert Centre
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Jan 2016 (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.
The purpose of this study is to assess whether twice-daily text message reminders over a six-month period to health workers in Malawi about diagnosis and treatment of malaria, pneumonia, and diarrhea improve case management of these diseases.
Detailed description
Background Mobile health, or m-health includes the use of portable devices, such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices to support medical and public health practice. Mobile phones are widespread in Asia and Africa, and dissemination of health-related messages via mobile phones is an inexpensive way to reach geographically dispersed recipients. Evidence from developing countries, is scarce, particularly for improving health service delivery. Only one rigorously designed study, a randomized controlled trial in Kenya, assessed the use of mobile phone text messaging to improve health worker case management practices, showing that sending daily text message reminders to health workers over six months led to a 24-percentage-point improvement in correct management of uncomplicated malaria.
Malaria is endemic throughout Malawi and poses a significant burden for the health system. Malawi changed its malaria case management guidelines in 2011 to require diagnostic confirmation with microscopy or a malaria rapid diagnostic test (RDT) prior to treatment. A health facility survey in 2011 prior to the rollout of RDTs found that only 67% of patients with malaria were correctly treated, primarily due to a missed diagnosis of malaria. Although more recent assessments are lacking, it is likely that Malawi faces similar problems documented in other sub-Saharan African countries: non-systematic diagnostic testing of febrile patients for malaria, poor adherence to negative test results, failure to administer the first dose of antimalarial therapy during the consultation, and gaps in patient counseling. Furthermore, additional assessments have pointed to deficiencies in quality of care for other common illnesses in Malawi, such as pneumonia and diarrhea, which are similar to some of the widespread quality problems found in other developing countries.
Study design and objectives
This study is a trial of text message reminders to health workers in Malawi to improve case management of malaria and other common illnesses. The study will employ a cluster-randomized, controlled trial design with pre- and post-intervention measures, with health facilities as the cluster and unit of randomization. In several districts of Malawi, health facilities will be randomized to one of three arms:
- Text messages to health facility-based health workers on the correct management of malaria (patients of all ages)
- Text messages to health facility-based health workers on the correct management of malaria (patients of all ages) and other common illnesses, per Integrated Management of Childhood Illness guidelines (patients < 5 years)
- Control health facilities where health workers receive no study intervention (only routine supervision and supports from supervisors and district health management team, which will occur in text message arms as well)
Justification
This study will add to the small but growing body of literature on the potential for cell phones and text messages to improve malaria case management in different settings. In addition to providing evidence from a rigorously designed study on the effectiveness of text message reminders to health workers to improve malaria case management, this proposed study expands on the promising initial evidence base in the following ways:
- Assesses the effectiveness of text message reminders in a setting with malaria diagnostic testing
- Expands the intervention to include patients of all ages, not just children < 5 years
- Includes messages on common non-malarial illnesses, including pneumonia and diarrhea
Methodology All health workers providing clinical care or working in the pharmacy dispensing drugs at facilities randomized to arms 1 or 2 will receive text messages. Before the intervention, data collection via a cross-sectional health facility survey will occur in the three study arms and will include patient exit interviews with a focused history, physical examination, and blood smear; health worker interviews; and a brief facility assessment. Results from this survey will be used to measure the baseline levels of case-management quality for malaria and other diseases and to pinpoint performance deficiencies to target with the text message intervention. Once preliminary baseline results are available, a workshop will be held with key stakeholders, including National Malaria Control Programme staff, researchers, technology specialists, health education specialists, and health workers, to discuss the results and design an appropriate intervention strategy, including message content and timing.
Text message reminders on case management of malaria (arm 1) and of malaria and other common illnesses (arm 2) will be sent to health workers twice a day in the intervention groups for six months. At the end of the six-month text message intervention, approximately one year after the baseline survey, follow-up data will be collected with another cross-sectional health facility survey. At this time, in-depth interviews will also be conducted with selected health workers in intervention facilities to better understand their reactions to the text messages and to help determine mechanisms of action of the text message reminders. A second follow-up health facility survey will be conducted six months after the end of the intervention to assess the extent that changes in performance are maintained over time. Cost data on the intervention will also be collected for a cost-effectiveness analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Malaria-only text messages | Experimental | Behavioral: Malaria text message reminders to health workersHealth workers at facilities in this arm receive twice-daily text message reminders for six months on key reminders related to malaria diagnosis and treatment. |
| Malaria, pneumonia, and diarrhea messages | Experimental | Behavioral: Malaria, pneumonia, and diarrhea text message reminders to health workersHealth workers at facilities in this arm receive twice-daily text message reminders for six months on key reminders related to diagnosis and treatment of malaria, pneumonia, and diarrhea |
| Control | Placebo comparator | Behavioral: ControlNo text message reminders to health workers, just the usual health system supports. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- For health workers to receive text messages: Providing outpatient care or dispensing drugs at health facility randomized to one of two intervention arms.
- For health workers to be interviewed during baseline, endline, and follow-up surveys: working in the outpatient department sampled by the team during their visit.
- For patients to be interviewed during baseline, endline, and follow-up surveys: visiting facility to see a clinician for the first time for current illness
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Malaria text message reminders to health workersText message reminders contain key details from national case management guidelines on diagnosis and treatment of malaria | Behavioural | Malaria-only text messages |
| Malaria, pneumonia, and diarrhea text message reminders to health workersText message reminders contain key details from national case management guidelines on diagnosis and treatment of malaria, pneumonia, and diarrhea | Behavioural | Malaria, pneumonia, and diarrhea messages |
| ControlNo text message reminders | Behavioural | Control |
Primary outcome
Questionnaire measurement of diagnosis and treatment of malaria among outpatients
Time frame: 12 months after end of text messages
Patient exit interviews will be used to assess: 1) whether all suspect malaria patients are tested with a malaria diagnostic test; 2) whether patients with a positive test are prescribed the first- or second-line antimalarial; and 3) whether dosing of antimalarials are correct.
2 secondary outcomes
Questionnaire measurement of diagnosis and treatment of pneumonia among outpatients
Time frame: 12 months after end of text messages
Questionnaire measurement of diagnosis and treatment of diarrhea among outpatients
Time frame: 12 months after end of text messages
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 12 Dec 2017.
- Results publication: PubMed 21820166Zurovac D, Sudoi RK, Akhwale WS, Ndiritu M, Hamer DH, Rowe AK, Snow RW. The effect of mobile phone text-message reminders on Kenyan health workers' adherence to malaria treatment guidelines: a cluster randomised trial. Lancet. 2011 Aug 27;378(9793):795-803. doi: 10.1016/S0140-6736(11)60783-6. Epub 2011 Aug 3.
- Derived from this study: PubMed 30628566Steinhardt LC, Mathanga DP, Mwandama D, Nsona H, Moyo D, Gumbo A, Kobayashi M, Namuyinga R, Shah MP, Bauleni A, Troell P, Zurovac D, Rowe AK. The Effect of Text Message Reminders to Health Workers on Quality of Care for Malaria, Pneumonia, and Diarrhea in Malawi: A Cluster-Randomized, Controlled Trial. Am J Trop Med Hyg. 2019 Feb;100(2):460-469. doi: 10.4269/ajtmh.18-0529.
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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.
Don Mathanga, MD, PhD principal investigator
Malaria Alert Centre
Questions about this trial
What is this clinical trial studying?
A study testing Malaria text message reminders to health workers and Malaria, pneumonia, and diarrhea text message reminders to health workers in people with Malaria and Pneumonia, run by Centers for Disease Control and Prevention.
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 0 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Questionnaire measurement of diagnosis and treatment of malaria among outpatients (time frame: 12 months after end of text messages). 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 NCT02645513, which also lists 2 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 12 Dec 2017.