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Rationale and design of mDOT-HuA study: a randomized trial to assess the effect of mobile-directly observed therapy on adherence to hydroxyurea in adults with sickle cell anemia in Tanzania

Overview of attention for article published in BMC Medical Research Methodology, October 2016
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Title
Rationale and design of mDOT-HuA study: a randomized trial to assess the effect of mobile-directly observed therapy on adherence to hydroxyurea in adults with sickle cell anemia in Tanzania
Published in
BMC Medical Research Methodology, October 2016
DOI 10.1186/s12874-016-0245-9
Pubmed ID
Authors

Abel Makubi, Philip Sasi, Mariam Ngaeje, Enrico M. Novelli, Bruno P. Mmbando, Mark T. Gladwin, Julie Makani

Abstract

Hydroxyurea (HU) has been demonstrated to be efficacious in reducing complications in individuals with sickle cell anemia (SCA) but poor adherence is a barrier. Directly Observed Therapy (DOT) has been shown to improve adherence in various chronic diseases but there is limited data in adults with SCA. To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) in adults with SCA at Muhimbili National Hospital in Tanzania. The mDOT-HuA study is a single centre, prospective, randomized, open label clinical trial. One-hundred individuals with SCA with haemoglobin SS genotype, aged ≥18 years, living in Dar es Salaam, able and willing to record and submit videos electronically will be included. Participants will be divided into two treatment arms; 50 in the standard monitoring (SM) arm will receive mobile phones and fixed dose HU therapy with standard monitoring; 50 in the mDOT arm will receive mobile phones, fixed dose HU therapy with standard monitoring and a mobile directly observed web based medication adherence monitoring system. The primary outcome is the proportion of participants achieving ≥80 % HU adherence compared between the two arms as assessed through medication possession ratio at the end of 3 months of treatment. REDCap, an open source software application will be used to collect data using clinical research forms. The proportions of adherence in the two arms will be compared by Fisher's exact test. Analysis of outcomes will have performed by both the intention-to treat and per-protocol methods. Should this study become sucessful, it will have the potential for the development of novel strategies for improving HU adherence in SCA. ClinicalTrials.gov Identifier: NCT02844673 , registered on 25(th)t July 2016 (retrospectively registered).

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 82 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 82 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 17 21%
Researcher 8 10%
Student > Bachelor 8 10%
Student > Postgraduate 6 7%
Professor > Associate Professor 4 5%
Other 13 16%
Unknown 26 32%
Readers by discipline Count As %
Medicine and Dentistry 15 18%
Nursing and Health Professions 10 12%
Pharmacology, Toxicology and Pharmaceutical Science 7 9%
Biochemistry, Genetics and Molecular Biology 6 7%
Social Sciences 5 6%
Other 10 12%
Unknown 29 35%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 01 November 2017.
All research outputs
#18,480,433
of 22,899,952 outputs
Outputs from BMC Medical Research Methodology
#1,748
of 2,025 outputs
Outputs of similar age
#239,297
of 316,303 outputs
Outputs of similar age from BMC Medical Research Methodology
#36
of 42 outputs
Altmetric has tracked 22,899,952 research outputs across all sources so far. This one is in the 11th percentile – i.e., 11% of other outputs scored the same or lower than it.
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We're also able to compare this research output to 42 others from the same source and published within six weeks on either side of this one. This one is in the 9th percentile – i.e., 9% of its contemporaries scored the same or lower than it.