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Efficacy of Mobile Phone Short Message Service (SMS) Reminders on Malaria Treatment Adherence and Day 3 Post-Treatment Reviews (SMS-RES-MAL) in Kenya: A Study Protocol.

Journal of clinical trials · 2019 · Unclear · Insufficient evidence

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UnclearInsufficient evidencePaper 2911

This is a study protocol for an open-label randomized controlled trial evaluating whether mobile phone SMS reminders (added to standard of care) improve malaria treatment adherence and day 3 post-treatment reviews compared with standard of care alone.

Study snapshot

PublicationJournal of clinical trials · 2019
Study typerandomized_trial
Reported directionUnclear
Evidence ratingInsufficient

Abstract

BACKGROUND: Mobile phone short messaging services (SMS) have been investigated in health information reporting, provider performance, drug and diagnostic stock management and patient adherence to treatment for chronic diseases. However, their potential role in improving patients' adherence to malaria treatment and day 3 post treatment reviews remains unclear. METHODS/DESIGN: A "proof of concept" open label randomised controlled trial will be conducted at four sites in Western Kenya. Principal research questions are: 1) Can mobile phone SMS reminders improve patient adherence to malaria treatment? 2) Can mobile phone SMS reminders improve day 3 post treatment reviews? Eligible caregivers (n=1000 per arm) of children under five years old with uncomplicated malaria will be randomly assigned (one to one) to: a) the current standard of care (provider counselling and health education); and b) the current standard of care plus SMS reminders. Within each arm, caregivers will be further randomized to three different categories. In categories 1 and 2, 300 caregivers per arm per category will be visited at home on day 1 and 2 of follow up respectively, to measure appropriate timing and adherence of the second Artemether-Lumefantrine (AL) dose and doses 3 and 4. Further, caregivers in categories 1 and 2 will be required to come to the health facility for the day 3 post treatment reviews. Finally, in category 3, 400 caregivers per arm will be visited at home on day 3 to measure adherence for the full AL course. Each category will be visited at home only once to avoid biases in the measures of adherence as a result of home consultations. Primary outcomes will be adherence to the full AL course (category 3), as well as, the proportion of patients reporting back for day 3 post treatment reviews (categories 1 and 2). The primary analysis will be intention-to-treat. Costs of the intervention will be measured over the period of the intervention, and a cost-effectiveness ratio will be estimated. DISCUSSION: If successful, evidence from this trial could improve malaria treatment adherence and offer pragmatic approaches for antimalarial drug resistance surveillance and risk mitigation in Africa. CURRENT CONTROLLED TRIALS: ISRCTN39512726.

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AI evidence extraction

Structured fields below were generated from the paper’s abstract and metadata to make the evidence easier to inspect. Automated extraction may be incomplete or incorrect; verify important details against the original paper.

Study typerandomized_trial
Effect directionunclear
PopulationCaregivers of children under five years old with uncomplicated malaria in Western Kenya
Sample size2000
ExposureNot supplied
Evidence strengthInsufficientConfidence: 74% · Peer reviewed: yes

Main findings

This is a study protocol for an open-label randomized controlled trial evaluating whether mobile phone SMS reminders (added to standard of care) improve malaria treatment adherence and day 3 post-treatment reviews compared with standard of care alone.

Outcomes measured

  • Adherence to the full Artemether-Lumefantrine (AL) course
  • Proportion of patients reporting back for day 3 post-treatment reviews
  • Timing/adherence of AL doses (second dose; doses 3 and 4)
  • Intervention costs
  • Cost-effectiveness ratio

Limitations

  • Protocol only; no results reported in abstract
  • Open-label design
View raw extracted JSON
{
  "study_type": "randomized_trial",
  "exposure": {
    "band": null,
    "source": "mobile phone",
    "frequency_mhz": null,
    "sar_wkg": null,
    "duration": null
  },
  "population": "Caregivers of children under five years old with uncomplicated malaria in Western Kenya",
  "sample_size": 2000,
  "outcomes": [
    "Adherence to the full Artemether-Lumefantrine (AL) course",
    "Proportion of patients reporting back for day 3 post-treatment reviews",
    "Timing/adherence of AL doses (second dose; doses 3 and 4)",
    "Intervention costs",
    "Cost-effectiveness ratio"
  ],
  "main_findings": "This is a study protocol for an open-label randomized controlled trial evaluating whether mobile phone SMS reminders (added to standard of care) improve malaria treatment adherence and day 3 post-treatment reviews compared with standard of care alone.",
  "effect_direction": "unclear",
  "limitations": [
    "Protocol only; no results reported in abstract",
    "Open-label design"
  ],
  "evidence_strength": "insufficient",
  "confidence": 0.74,
  "peer_reviewed_likely": "yes",
  "keywords": [
    "SMS reminders",
    "mobile phone",
    "randomized controlled trial",
    "malaria",
    "treatment adherence",
    "day 3 post-treatment review",
    "Kenya",
    "study protocol",
    "Artemether-Lumefantrine",
    "cost-effectiveness"
  ],
  "suggested_hubs": []
}
AI can be wrong. Always verify against the paper.

AI-extracted fields are generated from the abstract and metadata and may be incomplete or incorrect. This material is for informational purposes and is not medical advice.

Identifiers and source

DOI: 10.4172/2167-0870.1000217
PubMed: 31285980

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