Call for Life Sepsis

Sponsor
Makerere University
Study ID
NCT07407868
Status
Recruiting
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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Interactive Voice Response system-Call for life IVR — OTHER
    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.

Study Details

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 * 90- day all-cause mortality post discharge Secondary end points * Time to death * 28-day all-cause mortality * Attendance within 14-day check-up post discharge * Re-admission within 28 and 90 days * Days alive and out of hospital (DAOH) * Quality of life score (Baseline vs 28 day and Baseline vs 90 days) * Differences in baseline demographic and clinical characteristics (e.g., age, sex, disease severity, comorbidities, key laboratory values) between randomized participants and screen failures. Study design: This is an open-label, randomized, parallel, interventional study, with two post-discharge follow-up strategies: 1) EDI; or 2) EDI plus IVR system. Fixed allocation randomization at a 1:1 ratio will be applied to either study arm. 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.

Key Dates

First listed
Feb 12, 2026
Start date
Jun 10, 2026
Status verified
Aug 2026
Primary completion
Mar 15, 2028
Completion
Jun 15, 2028

Study Design

Enrollment
1,410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Enhanced Discharge Intervention (EDI)
    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
  • Experimental: EDI plus IVR tool ( EDI-CFL IVR)
    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.

Primary Outcome Measure

All-cause mortality by Day 90 post-discharge (binary; time-to-event) [ Time Frame: Day 90 post discharge ]

Central Contacts

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