NCT02435719

Brief Summary

Ministry of Health through the National Medical Stores has supplied alcohol-based handgels to the different health facilities in Uganda for the health care providers to use during clinical care. However, constant stock-outs and or limited supplies remains the main constraint faced by the hospitals. Thus the handgels are generally used by a few of the senior health care providers. The promotion of bedside, antiseptic handrubs largely contributes to the increase in compliance and sustained improvement of hand hygiene compliance reduces Health care acquired infections (HCAIs), but it is not yet established how cost- effective the intervention is in a a rural Ugandan hospital where funds are severely rationed and, which serves over 4 million people in over 15 districts in Uganda. An evaluation of an intervention's cost-effectiveness is a crucial factor in whether the government will be prepared to fund the intervention and sustain it. This WardGel study thus aims to assess the cost-benefit of providing hand gel for all health care workers in Mbale Regional Referral Hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,626

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

April 20, 2015

Last Update Submit

October 12, 2016

Conditions

Keywords

HCAIsHandgelHospitalEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Evidence of Hospital acquired infection confirmed clinically

    Hospital acquired infection will be defined as new clinically diagnosed infection developed whilst an inpatient or within 2 days of discharge (for readmitted patients).

    At least 48 hours after hospital admission or re-admission.Participants will be followed for the duration of hospital stay, an expected average of 5 days.

Secondary Outcomes (3)

  • Evidence of Hospital Acquired infection confirmed by laboratory investigations (CBC and C&S)

    At least 48 hours after admission or readmission.Participants will be followed for the duration of hospital stay, an expected average of 5 days.

  • Hand hygiene compliance by health care providers based on the WHO's 5-moments of Hand hygiene

    during patient clinical care.participants will be observed during their clinical care practice, an expected average of 30 minutes per session

  • cost-effectiveness of hand gel use by micro-economic assessment

    Additional period due to confirmed hospital acquired infection.Participants will be followed for the duration of hospital stay, an expected average of 5 days.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include in-patients and health care providers on six (6) selected wards (Labour ward, Postnatal ward, Gynaecological ward, Acute Care unit, paediatric Ward, and general surgical wards) The sample will be selected by convenience non-probability sampling method

You may qualify if:

  • Patients is admitted for at least 24 hours
  • Any health care provider, including students

You may not qualify if:

  • Patients discharged before 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbale Regional Referral hospital

Mbale, Uganda

Location

Related Publications (1)

  • Saito H, Inoue K, Ditai J, Wanume B, Abeso J, Balyejussa J, Weeks A. Alcohol-based hand rub and incidence of healthcare associated infections in a rural regional referral and teaching hospital in Uganda ('WardGel' study). Antimicrob Resist Infect Control. 2017 Dec 28;6:129. doi: 10.1186/s13756-017-0287-8. eCollection 2017.

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Weeks, PhD

    University of Liverpool

    PRINCIPAL INVESTIGATOR
  • James Ditai, MPH

    Sanyu Africa Research Institute

    PRINCIPAL INVESTIGATOR
  • Benon Wanume, MMED (CP)

    Mbale Regional Referral Hospital

    PRINCIPAL INVESTIGATOR
  • Julian Abeso, MMED (Paed)

    Mbale Regional Referral Hospital

    STUDY DIRECTOR
  • Kyoko Inoue, MPH

    Nagasaki University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

May 6, 2015

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations