Mobile-Directly Observed Therapy on Adherence to Hydroxyurea

Sickle Cell Anaemia Clinical Trial

— mDOT  

Official title:

Effect of Mobile-Directly Observed Therapy (DOT) on Adherence to Hydroxyurea Treatment in Adult HbSS Patients at Muhimbili National Hospital (MNH) in Tanzania: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844673
• Other study ID #: MUPI-001
• Status: Completed
• Phase: Phase 2
• Start date: April 28, 2017
• Est. completion date: May 18, 2018

Study information

• Verified date: June 2024
• Source: Muhimbili University of Health and Allied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) adults with SCA at Muhimbili National Hospital (MNH) in Tanzania.

Description:

Background: Hydroxyurea (HU) has been demonstrated to be efficacious in reducing complications in individuals with Sickle Cell Anemia (SCA) but poor adherence is a barrier to improving outcomes in patients with SCA. Directly Observed Therapy (DOT) has been shown to improve adherence in various chronic diseases but there is limited data in adults with sickle cell anaemia (SCA).

Methods and design: To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) adults with SCA at Muhimbili National Hospital (MNH) in Tanzania.The mDOT-HuA study is single centre, prospective, randomized, open label clinical trial. 100 participants with SCA with hemoglobin SS genotype, aged ≥18 years, living in urban Dar es Salaam and able and willing to participate in the study. Participants will be divided into two treatment arms; 50 in standard monitoring (SM) arm: will receive fixed dose HU therapy with standard monitoring. 50 in treatment mDOT arm: will receive fixed dose HU therapy with standard monitoring and a mobile direct observed web based medication adherence monitoring system. The primary outcome is adherence to HU as defined as medication possession ratio of ≥80 at end of 3 months of HU treatment and mDOT monitoring. Secondary outcomes will be efficacy to HU treatment as measured through the the mean change in fetal hemoglobin (between baseline and end of 3 months) and safety, measured as the proportion of participants experiencing serious adverse events related to HU at week 2, 6, 10 and at the end of 3 months.

REDCap, an open source software application will be used to collect data using clinical research forms.

Conclusion: This project has the potential for the development of novel strategies for improving HU adherence in SCA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 18, 2018
• Est. primary completion date: January 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years and living in urban Dar es Salaam

• Male or female (post-menopausal, sterile, or using an acceptable method of contraception)

• Negative urine pregnancy test at Screening and a negative urine pregnancy test (dipstick) prior to randomization and dosing

• Hemoglobin SS genotype

• Absolute neutrophil count >1,500/uL

• Platelet count >95,000/uL

• Serum creatinine< 100 µmol/L (1.2 mg/dL)

• Alanine transaminase (ALT) less than two times the upper limit of normal

• Being able and willing to record and submit videos electronically

Exclusion Criteria:

• Chronic transfusion program as defined by participating in a scheduled (pre-planned) series of transfusions for prophylactic purposes or has a hemoglobin A level that is >20% of the total hemoglobin

• Hemoglobin <4.0 g/dL

• HIV positive

• Female planning to become pregnant during the study period

• Serious mental (including psychosis) or physical illness, which, in the opinion of the Investigators would compromise participation in the study (e.g. impaired mental capacity, alcoholism

• Any condition which the Investigators judge to preclude safe participation in the study or to confound the evaluation of the study outcome.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Anaemia

Intervention

Drug:
• Hydroxyurea
Patients will receive fixed dose Hydroxyurea therapy (15 mg/Kg/day) with standard monitoring

Device:
• Mobile Directly Observed Therapy
Mobile DOT will consist of a web based medication adherence monitoring system that includes direct video confirmation of adherence using the patient's personal cellular telephone. Patients will receive alerts on their cell phone at pre-arranged times to remind them to take their medications.

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Sciences	Dar es Salaam

Sponsors (3)

Lead Sponsor	Collaborator
Muhimbili University of Health and Allied Sciences	Muhimbili National Hospital, University of Pittsburgh

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of laboratory adverse events, fever and other sickle cell anemia symptoms	The incidence during 3 months of treatment will be compared with the incidence during pre-treatment period	At the end of 3 months Hydroxyurea treatment and monitoring
Other	Level of leucopenia in relation to incidence rates of fever as indicator of possible infection	The level of leucopenia in relation to incidence rate of fever during 3 months of treatment with be compared with that during the pre-treatment period	At the end of 3 months Hydroxyurea treatment and monitoring
Other	Mean change in estimated glomerular filtration rate as a measure of kidney function	The mean change in estimated glomerular filtration rate will be evaluated as an indicator of deteriorating renal function after Hydroxyurea exposure	At the end of 3 months Hydroxyurea treatment and monitoring
Other	Mean change in the level of Lactate Dehydrogenase (LDH) from baseline	Serum LDH level (U/L) is usually elevated in sickle cell anemia indicating hemolysis. A decrease in the level of LDH will be considered favorable effect of Hydroxyurea	At the end of 3 months Hydroxyurea treatment and monitoring
Other	Mean change in reticulocyte count from baseline	Reticulocyte count is usually increased in sickle cell anemia, indicating of hemolysis (a decrease in reticulocyte count % will be considered favorable effect of Hydroxyurea)	At the end of 3 months Hydroxyurea treatment and monitoring
Primary	The proportion of participants achieving =80% HU adherence as assessed through medication possession ratio.	The proportion of participants achieving =80% HU adherence will compared between the two arms.	At the end of 3 months of Hydroxyurea treatment and monitoring.
Secondary	Efficacy of Hydroxyurea treatment as measured through the mean change in fetal hemoglobin (%),	The mean change in fetal hemoglobin (between baseline and end of 3 months) will be compared between the two arms.	At the end of 3 months of Hydroxyurea treatment and monitoring.
Secondary	The proportion of participants experiencing serious adverse events (SAE) related to hydroxyurea	The overall proportion of participants experiencing SAE during the 3 months of Hydroxyurea treatment will be evaluated as a measure of the safety of treatment with Hydroxyurea	at week 2, 6 ,10 and at the end of 3 months of Hydroxyurea treatment and monitoring.