An interventional study of Interactive Voice Response system-Call for life IVR in Sepsis, sponsored by Makerere University. Recruiting at 2 sites in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Makerere University · Not applicable, Interventional, and Supportive care
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis-attributable mortality in sub-Saharan Africa (sSA) is high, with in-hospital mortality in some settings approaching 40%. Studies show that mortality among children under 5 years hospitalized with sepsis remains high within the first 6 months of discharge. Additionally, high mortality has been observed among other populations within sSA, with factors such as HIV infection being associated with increased risk. Reducing sepsis deaths contributes to the achievement of the Sustainable Development Goals (SDG), particularly SDG 3 in reducing maternal mortality (3.1), neonatal and under five mortality (3.2), and burden of mortality from communicable diseases (3.3) and improving universal health coverage (3.8). The World Health Organization (WHO) has recognized sepsis as a global priority, with low- and middle-income settings being particularly affected. In sSA, sepsis is commonly associated with infectious diseases like malaria, Human Immunodeficiency Virus/ Acquired Immunodeficiency Syndrome (HIV/AIDS), pneumonia, tuberculosis, and diarrhea. Guidelines from the Surviving Sepsis Campaign (SSC) have become standard in some settings. However, little is known about patients' status post-discharge. This study aims to evaluate two post-discharge follow-up strategies for adult sepsis patients. Study duration is 45 months, participants will receive intervention up to 90 days post discharge.
Description of intervention: Post-discharge follow-up strategy 1: Enhanced Discharge Intervention (EDI) Post-discharge follow-up strategy 2: EDI plus Interactive Voice Response (IVR)
*All participants will receive a feature phone.
Objectives:
The study aims to evaluate two post-discharge follow-up strategies for adult patients hospitalized with sepsis, focusing on their efficacy in reducing the 90-day mortality, and their effect on return to follow-up, number of re-admissions, and quality of life.
Primary efficacy endpoint
Sample size: A total of 1,410 (705 per arm) from the four countries (Uganda, Nigeria, Ghana and Mozambique) will be enrolled competitively across the sites.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 1,410 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At admission
Participant's hospital admission diagnosis is consistent with the following broad definition of sepsis, incorporating its principal components (signs of infection plus signs of severity/organ dysfunction):
Exclusion Criteria:
At Admission;
The patient is unable to speak English and Luganda.
At discharge
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. A standardized form provided around the time of hospital discharge (within 24 hours) with detailed information including the clinical course during hospitalization, including description of management and laboratory and clinical findings, discharge diagnosis, and any recommendations and treatment at discharge. The form will include a recommendation for a scheduled follow-up visit with a non-study clinician at the health facility from which the participant was discharged within 14 days after hospital discharge. 2. Standardized information education communication (IEC) materials that include explanations and descriptions (e.g., pictorial depictions) of emergency signs for sepsis and key triggers for seeking care
EDI at the time of discharge, plus IVR tool: Participants will be provided analog phones with loaded airtime pro-rated to 3 months and instructions on battery charging. Features will include: 1. Automated IVR using Call for Life for status checks and optional health information tips at day 0, 1, 2, 7 and every 7 days within the first 28 days, followed by every 14 days from day 29 to day 90. 2. Reminders at 24 hours (day 13) and 48 hours (day 12) prior to scheduled appointments. 3. Alerts mapped onto the dash board, the alerts may be due to missed clinic visit or symptoms reported by clients/participants. In case of a missed clinic, alert, the study clinician will inform the clinician in charge of client management to make a follow-up on the client who has missed a visit. In case of a symptom alert or report of symptoms requiring rapid follow-up, the study clinician gives medical advice to patients accordingly and this is documented in the system.
Other: Interactive Voice Response system-Call for life IVR
The CFL-Sepsis system will be developed for this trial to provide sepsis-related health information tips for adult patients who have recovered from a sepsis hospitalization. In this trial, the IVR will be used to reach out to the participants through a phone call. The purpose of the IVR will be to help the patient report on any symptoms that will need a clinician's advice, the system will help deliver status checks on participants' well-being and deliver general information and health education on sepsis, including danger signs.
All-cause mortality by Day 90 post-discharge (binary; time-to-event)
To determine the effect of EDI + IVR versus EDI alone on 90-day all-cause mortality after hospital discharge
Time frame: Day 90 post discharge
Plan to share: Undecided — This needs teh TMG to decide and approval of Data sharing agreement by the Uganda National Council of Science and Technology
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Mar 2028, 21 months after the start.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 21 months is close to that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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