Self-management Intervention for Reducing Epilepsy Burden Among Ugandans With Epilepsy.

NCT06139198 | Recruiting DMC

• 1 other identifier: Mak-SOMREC-2023-648
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the efficacy of self management intervention for reducing epilepsy burden among Ugandans with epilepsy (SMART- U) vs. enhanced treatment as usual (eTAU) via an RCT in adults with epilepsy. The main question\[s\] it aims to answer are:

• What is the efficacy of SMART - Uganda (SMART-U) versus enhanced treatment as usual (eTAU) among PWE?
• How does short message service (SMS) delivered by mobile phone text validate self-reported seizure occurrence? Participants will be randomly (1:1 basis) assigned to receive either SMART-U (N=94) or eTAU (N=94) using block randomization. SMART-U will consist of 2 main components: a 12-week "intensive" group format stage and a 12-week remotely accessed telephone follow-up stage. Individuals randomized to eTAU will continue in their usual care supplemented by written materials on epilepsy in their preferred language and tailored to the reading level of most patients at the clinic. If there is a comparison group: The investigators will compare the mean change in seizure frequency and quality of life from baseline and 24 weeks of follow up.

Conditions

Epilepsy

Keywords

seizure frequency; self management; SMS; quality of life

Outcome Measures

Primary Outcomes (2)

• Mean change in cumulative past 24-week seizure frequency (24 weeks prior to study baseline compared to the 24-week follow-up

  We will compare the change in baseline and 24 week seizure frequency

  24 weeks

• Mean change from baseline to 24 weeks in QOL. QOL will be assessed by the 31-item Quality of Life in Epilepsy (QOLIE-31) questionnaire.

  We will assess the change in quality of life from baseline and 24 weeks among adults with epilepsy. The Quality of life in Epilepsy questionnaire (QOLIE-31) measures the self reported quality of life and requires the conversion of raw data to a scale of 0 to 100 for each sub-scale, with higher scores reflecting higher quality of life. The total score is calculated as a weighted mean of the sub-scale scores. The minimum score is zero while the maximum is 100.

  24 weeks

Secondary Outcomes (1)

• We will evaluate effects of SMART-U on depressive symptoms using the Hospital Anxiety and Depression scale (HADS).

  24 weeks

Study Arms (2)

SMART-U intervention arm

EXPERIMENTAL

SMART-U will consist of 2 main components: a 12-week "intensive" group format stage and a 12-week remotely accessed telephone follow-up stage.

Behavioral: Self-MAnagement intervention for Reducing The epilepsy burden among Ugandans

Enhanced Treatment as usual

NO INTERVENTION

The participants will have usual care supplemented by written materials on epilepsy in their preferred language and tailored to the reading level of most patients at the clinic.

Interventions

Self-MAnagement intervention for Reducing The epilepsy burden among Ugandans BEHAVIORAL

SMART-U sessions are operationalized in written curricula, including an intervention manual, participant manual, slides, and handouts typically delivered over a period of 10-12 weeks.

SMART-U intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will have a clinical diagnosis of epilepsy documented with at least two outpatients visits; this will ensure that the study participants have been taking ASMs but still getting breakthrough seizures.
• ≥ age 18, attending the neurology clinics,
• Be able to provide written informed consent by the study participant or immediate caregiver/legal guardian,
• Ability to participate in study procedures, this is due to time required to attend and participate in the scheduled sessions which may last between 45mins - 1 hour.
• and have had at least 1 seizure in the past 6 months.
• Owning a mobile phone either by the PWE or immediate caregiver

You may not qualify if:

• Participants with dementia
• Participants who are pregnant (given the likely need of different and more intensive treatments among pregnant PWE that may affect their ability to participate in the SMART-U sessions regularly.
• Or those who are unable to participate in study procedures.

Sponsors & Collaborators

• Makerere University: lead
• Case Western Reserve University: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Mbarara University of Science and Technology: collaborator

Study Sites (1)

Mulago National Referral and Teaching Hospital

Kampala, Uganda

RECRUITING

Related Publications (2)

• Mbalinda SN, Kaddumukasa M, Najjuma JN, Birungi DR, Kaddumukasa MN, Levin JB, Still CH, Burant CJ, Modi AC, Katabira ET, Sajatovic M. Self-Management Intervention for Reducing Epilepsy Burden Among Adult Ugandans with Epilepsy (SMART-U): Randomised Clinical Trial Protocol. Neuropsychiatr Dis Treat. 2024 Nov 25;20:2277-2286. doi: 10.2147/NDT.S490050. eCollection 2024.

  PMID: 39619495 DERIVED

• Mbalinda SN, Kaddumukasa M, Najjuma J, Birungi D, Kaddumukasa M, Levin J, Still C, Burant C, Modi A, Katabira ET, Sajatovic M. Self-management Intervention for Reducing Epilepsy Burden Among Adult Ugandans With Epilepsy (Smart-u), Randomised Clinical Trial Protocol. Res Sq [Preprint]. 2023 Dec 2:rs.3.rs-3667486. doi: 10.21203/rs.3.rs-3667486/v1.

  PMID: 38077080 DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mark Kaddumukasa, MD

  Makerere University

  PRINCIPAL INVESTIGATOR

• Martha Sajatovic, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doreen Birungi, BA

CONTACT

+256772474096; bdoreen112@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization list will be computer-generated by personnel within the biostatistics core of the CWRU Neurological and Behavioral Outcomes Center who are not members of the study staff. the study team will train and follow up each study group independently from the other group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective non-inferiority randomized clinical trial

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: January 6, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)