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CompletedNCT05464017Updated Nov 9, 2026

Trauma Follow-Up Prediction (Project 2: Aim 2)

An interventional study of Standard mhealth screening tool in Injury Traumatic and Injuries, sponsored by University of Buea. Completed at 1 site in Cameroon. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University of Buea · Not applicable, Interventional, and Prevention

Updated Nov 9, 2026Now CompletedFirst site in Cameroon+6 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
9,079
Allocation
Not applicable
Sex
All
01

Study summary

Approximately 9% of the world's deaths, more than 5 million deaths annually, are due to injury. In high-income countries, where the epidemiology and outcomes of traumatic injury are well characterized, trauma primarily affects young, productive members of the population and is associated with significant long-term disability. In sub-Saharan Africa (SSA) countries like Cameroon, injured people face multiple obstacles to trauma care, including potentially lifesaving follow-up care after hospital discharge. The Investigators' community-based survey of 8,065 patients in South west Cameroon found that 34.6% of injured respondents did not seek immediate formal care after injury, and another 9.9% only sought formal care after alternative means, such as consultation with traditional medicine practitioners.

In Cameroon, for the 65.4% of injured people who seek formal care after injury,5 therapeutic itineraries can be complex, often involving poorly supported referrals to other facilities or transitions away from formal care. As a result, formal systems of care fail to retain trauma patients for follow-up care, a missed opportunity as these patients have already overcome significant financial and personal challenges to seek initial care for their injuries. Consequently, discharged trauma patients who may benefit from follow-up care often delay care until advanced complications develop.

The objective of this study is to evaluate a machine learning optimized phone-based screening tool that predicts which trauma patients are most likely to benefit from follow-up care. A Cluster randomized trial controlled trail will be carried out in 10 hospitals in Cameroon involving 852 trauma patients. The control group shall use the existing standard mHealth screening tool while the intervention shall use the optimized version of the mHealth screening tool (intervention) using the machine learning approach. Patients shall be followed up over a 6 months period to determine the proportion of trauma post discharge patients that need follow up care using mobile phone.

Read the detailed description

The technological convergence of mHealth and machine learning provides an unprecedented opportunity to transform injury care in SSA, particularly for disadvantaged populations. The ubiquity of mobile phones and the advent of mHealth provides a novel opportunity to improve injury care in SSA. Given high levels of mobile phone penetration in Cameroon (85% to 95%) and elsewhere in SSA, the investigators designed and piloted an mHealth, phone-based 7-item screening tool for trauma patients to predict the need for in-person follow-up care after discharge. If effective, this approach could efficiently identify the subset of patients most likely to benefit from follow-up care, which is more feasible, scalable, and cost-effective than blanket advice for post-discharge care. The investigators found that phone follow-up is feasible and acceptable and a validation study revealed good correlation of the screening tool with an independent, in-person exam.

Investigators will build upon their prior research and use data science to improve, implement and evaluate the mHealth screening tool, with the ultimate objective of reducing the crippling burden of injury. This will be achieved by leveraging on machine learning, which has demonstrated promise in optimizing trauma care and trauma systems.The novel combination of mHealth and machine learning provides a powerful opportunity to transform access to health care for those least likely to receive it. Building on existing knowledge, the investigators hypothesize that a data-adaptive, machine-learning approach to outcomes prediction could radically improve survival and reduce morbidity after injury in SSA.

Investigators will apply a machine learning approach to adaptively optimize the mHealth triage tool, improving the phone call timing and algorithm that predicts the need for follow-up care via a cluster randomized controlled trial. This will be achieved using SuperLearner for prediction and cross-validated targeted maximum likelihood estimation (CV-TMLE) for variable importance, using the trauma registry, contact attempt, and screening survey data collected in Aim 1. The overall goal is to improve the mHealth tool's prediction of vulnerable patients needing follow-up care after discharge. This study shall be conducted over an 12-month period; enrollment in 6 months and follow-up participants for 6 months. Investigators will evaluate the impact of the optimized approach in a randomized study in 10 hospitals with 852 injury patients with the primary outcome of the Glasgow Outcomes Scale-Extended (GOSE) score at 3 months.

We originally planned on using the combination of our mHealth surveys and trauma registry data to select a group of patients at greater risk of poor outcomes, for whom a more intensive follow-up could be beneficial. We also planned on using preliminary data to design a new "intensive" intervention that could be randomized to half of this group of selected patients and the other half to the standard of care mHealth survey (conducting surveys at 2 weeks, 1,3, and 6 months). However, we have discovered that 1) there was significant variability in the ability to contact patients, and given issues related to cellphone use and other factors, it was unclear that more intensive contact with this patient population is feasible, and 2) this variability allowed us enough natural experimentation to carry out our goals of this aim, which is to look at the intensity of contact by health workers and its impact on future health outcomes (GOSE score, death, etc.). This latter point means we can use the proposed Targeted Learning methodology with the mHealth data to develop new rules for engaging with patients after discharge, without the need for a sub-study with a randomized component. For instance, we have measures of the intensity of contact at 2 weeks, which now include patients that 1) never were reached for this wave, 2) were reached but did not start the survey portion, 3) they started but did not complete survey, and 4) both started and completed survey. We will then estimate (using our expertise in machine learning for causal inference) the association of this variation in contact and how that relates to future health outcomes (e.g., GOSE score collected at the 1 or 3-month survey). Initially, we anticipated that the four surveys for nearly all patients would be characterized by 4) above. However, we have experienced enough variation in the contact intensity (e.g., patients in categories 1-3 above), that we can identify both the causal impact of contact intensity (adjusting for a considerable number of baseline confounders in the CTR data), can use estimation of the CATE function to determine which patients are predicted to benefit the most from contact and survey, which patients are predicted to be harder to reach at a particular survey, and other functions that can provide actionable information on developing a protocol for patient follow-up.

This allows us, by using the natural variation in the mHealth surveys across and within patients, to accomplish the goals of Aim 2, without a new randomized sub-study. It will also require little to no change in the proposed methodology by which we identify patients at most significant risk of poor outcomes, who we predict will be hard to contact, and those patients that will benefit the most from being contacted by the mHealth surveyors.

02

Conditions studied

  • Injury Traumatic
  • Injuries

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Keywords

  • Cameroon
  • Sub-Sahara Africa
  • mHealth
  • Machine learning
  • Injury
  • Trauma
  • Mobile phone
  • SuperLearner
03

In context

Wounds and Injuries

2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.

This study's enrollment of 9,079 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

University of Buea is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Trauma Registry (CTR): Patients satisfying the following inclusion criteria will be included in the registry:

    1. Patients with acute traumatic injury i.e. within 2 weeks of presentation for care.
    2. Trauma patients who are formally admitted to the hospital as in-patients.
    3. Trauma patients who die upon arriving to the Emergency Departments or while admitted in the hospital.
    4. Trauma patients who are transferred to other health facilities.
    5. Trauma patients with indications for hospital admission (based on physicians' assessments) but leave against medical advice
    6. Trauma patients who are kept under observation in the Emergency Department for over 24 hours

Standard mHealth Triage Tool Eligibility: The mHealth triage tool will be administered to the subset of patients included in the trauma registry who are admitted then discharged home after treatment.

Optimized version of the mHealth screening tool (intervention) Eligibility: The optimized version of mHealth screening tool will be administered to the subset of patients included in the trauma registry who are admitted then discharged home after treatment.

Exclusion criteria

Exclusion Criteria:

  • Trauma Registry Exclusion criteria: Patients will not be excluded based on age, gender, race, or nationality. If patients or their surrogate decision-maker do not give consent to participation, those patients will be excluded.

According to the World Health Organization (WHO) injury definition, the following will be excluded from the definition of "injury": "Whereas the above definition of an injury includes drowning (lack of oxygen), hypothermia (lack of heat), strangulation (lack of oxygen), decompression sickness or "the bends" (excess nitrogen compounds) and poisonings (by toxic substances), it does NOT include conditions that result from continual stress, such as carpal tunnel syndrome, chronic back pain and poisoning due to infections. Mental disorders and chronic disability, although these may be eventual consequences of physical injury, are also excluded by the above definition." Although included in the WHO definition, poisonings will be excluded from the CTR as these have been extremely rare events in the CTR to date and are not typically included in trauma registries in most other contexts.

Patients who are not formally admitted and discharged within 24 hours from the Emergency Ward will be excluded.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9,079 participants (actual)

Study arms

  • Other
    Standard mHealth screening tool

    This is a tested standard phone screening tool which determines the need for in-person follow-up after a patient has been discharge. Consenting trauma patients will be contacted via mobile phone at 0.5, 1, 3, and 6 months post-discharge by a research assistant to complete the screening which will guide whether or not the patient should seek follow-up care based on the number of flagged responses to ≥1 question on the 7-item screening survey.

    Other: Standard mhealth screening tool

Interventions

  • OtherStandard mhealth screening tool

    This is a tested standard phone screening tool which determines the need for in-person follow-up after a patient has been discharge. Consenting trauma patients will be contacted via mobile phone at 0.5, 1, 3, and 6 months post-discharge by a research assistant to complete the screening which will guide whether or not the patient should seek follow-up care based on the number of flagged responses to ≥1 question on the 7-item screening survey.

06

What researchers measure

Primary outcomes

  1. Assess Glasgow Outcomes Scale-Extended (GOSE) score

    This outcome will measure recovery after traumatic injury and ranges from 1 (death), 2 (vegetative state), through 8 (good upper recovery).

    Time frame: At 3 months

Secondary outcomes

  1. GOSE score

    This outcome will measure recovery after traumatic injury and ranges from 1 (death), 2 (vegetative state), through 8 (good upper recovery).

    Time frame: At 6 months

  2. Proportion reached by mobile phones

    Number and proportion of hospitalized trauma patients who are reached by mobile phone after discharge in both arms

    Time frame: At 0.5, 1, 3, and 6 months

  3. Proportion needing follow-up care

    Number and proportion of hospitalized trauma patients who are reached by mobile phone post-discharge and who are identified by the screening tool as needing follow-up care.

    Time frame: At 0.5, 1, 3, and 6 months

07

Study locations

1 site
  • D-SINE Africa
    Buea, Southwest, Cameroon
08

References and documents

Individual participant data

Plan to share: No — De-identified individual participant data for all primary and secondary outcome measures will be made available upon reasonable request to Harnessing Data Science for Health Discovery and Innovation in Africa (DSI Africa) consortium and other researchers.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Nov 9, 2026
Sites
1 site added — first site in Cameroon
Show site
  • D-SINE Africa · Buea, Cameroon
Nov 9, 2026
Start date
Jun 2024→Jul 3, 2023 (actual)
Nov 9, 2026
Primary completion
Mar 2025→Dec 23, 2025 (actual)
Nov 9, 2026
Study completion
Dec 2025→Jun 23, 2026 (actual)
Nov 9, 2026
Enrollment
852 (estimated)→9079 (actual)
Nov 9, 2026
Interventions
Added Standard mhealth screening tool; removed Device: Optimized version of the mHealth screening tool (intervention) using the machine learning approach. Arms removed: Optimized version of the mHealth screening tool (intervention) using the machine learning approach
Nov 9, 2026
Secondary outcomes
1 time frame changed
What changed in the outcomes
  • Time frameGOSE scoreAt 6 and 12 months → At 6 months
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Not yet recruiting→Completed
    1 site added — first site in Cameroon
    Show site
    • D-SINE Africa · Buea, Cameroon
    Start date Jun 2024→Jul 3, 2023 (now actual)
    Primary completion Mar 2025→Dec 23, 2025 (now actual)
    Study completion Dec 2025→Jun 23, 2026 (now actual)
    Enrollment 852 (estimated)→9079 (actual)
    Secondary outcomes 1 time frame changed
    What changed in the outcomes
    • Time frameGOSE scoreAt 6 and 12 months → At 6 months
    Interventions Added Standard mhealth screening tool; removed Device: Optimized version of the mHealth screening tool (intervention) using the machine learning approach. Arms removed: Optimized version of the mHealth screening tool (intervention) using the machine learning approach
    + 5 other changes: verification date, description, design details, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05464017
Lead sponsor
University of Buea
Responsible party
Mefire Alain Chichom (Professor of Surgery, University of Buea) — Principal investigator
First posted
Jul 19, 2022
Start date
Jul 3, 2023
Primary completion
Dec 23, 2025
Completion
Jun 23, 2026
Last update
Nov 9, 2026

Study contacts

Alain Chichom-Mefire, MD
principal investigator · University of Buea
Catherine Juillard, MD, MPH
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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