Evaluation of Integrated Community Case Management in Ethiopia

NCT01606267 | Completed

• 1 other identifier: Grant # 109947
• Study Type: interventional
• Target: 607,770
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to to measure the effect of the HEP+ICCM program relative to routine HEP approach in rural Ethiopia on changes in coverage of case management of common childhood illnesses and severe acute malnutrition, reductions in mortality among children under the age of five, and improvements in nutritional status using a rigorous evaluation design.

Conditions

Pneumonia

Keywords

Integrated Community Case Management; Pneumonia; Ethiopia

Outcome Measures

Primary Outcomes (1)

• Mortality rate among children under-five (0-59 months)

  Over a 12 and 18 month period

Secondary Outcomes (5)

• Mortality rate among children 1-59 months

  Over a 12 and 18 month period

• Malnutrition of under-five children (wasting, stunting and underweight rates)

  Measured at 0 and 18 months

• Treatment coverage of childhood diarrhea, malaria, pneumonia and malnutrition

  Measured at 0 and 18 months

• Care-seeking coverage for childhood diarrhea, malaria, pneumonia and malnutrition

  Measured at 0 and 18 months

• Proportion of sick children observed who did not need urgent referral with a validated classification of pneumonia, malaria, diarrhea and/or SAM for whom all medications received correctly matched the validated prescription

  Measured once at 10 months (midterm)

Study Arms (2)

Routine HEP

NO INTERVENTION

This arm includes routine care provided under the health extension program provided to rural Ethiopian villages with limited access to health facilities.

HEP+ICCM

EXPERIMENTAL

This arm includes routine care provided under the Health Extension Program plus the HEWs will be assessing and treating childhood pneumonia cases in rural Ethiopian villages with limited access to health facilities.

Other: health systems intervention: HEP+ICCM

Interventions

health systems intervention: HEP+ICCM OTHER

In the HEP+ICCM intervention areas, HEWs will assess and treat childhood pneumonia with cotrimoxazole. The program will strengthen the capacity of HEWs to assess, classify and treat malaria (with ACTs), diarrhea (with ORS) and undernutrition (with therapeutic feeding) through refresher trainings and strengthening supervision, logistical support and the ICCM system overall.

HEP+ICCM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Surveys:
• Members of households in evaluation woredas in Jimma and West Haraghe zones of Ethiopia.
• Quality of Care Implementation snapshot:
• Health posts: All functional health posts in the study zones will be included in the sampling frame. In cases where an HEW is providing services, but an official health post structure has not been constructed, the HEW's primary location for providing case management services will be considered as the health post.
• HEWs: All HEWs providing case management services in selected health posts will be included.
• Patients must meet the following criteria:
• Between 2 and 59 months of age;
• Described as sick by the caretaker. Sick children must have at least one of the following complaints: signs or symptoms of severe illness (change in consciousness/lethargy, convulsions, vomiting everything, not eating or drinking); fever/malaria; cough, fast/difficulty breathing, pneumonia; diarrhea/vomiting; ear problem; measles; nutrition or feeding problems;

You may not qualify if:

• Surveys:
• Members of households NOT residing in the evaluation woredas in Jimma and West Haraghe zones of Ethiopia.
• Members of households in urban communities.
• Participant does not consent to study procedures
• Quality of Care Implementation snapshot:
• Non-functional health posts
• HEW does not consent to procedure.
• Patients will be excluded from the study:
• If this is not the initial consultation for the current illness episode: patient has been seen at the health post, by the HEWs (including home/community).
• Patient is younger than 2 months or older than 59 months.
• Caretaker does not consent to procedure.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Canadian International Development Agency: collaborator
• UNICEF: collaborator

Study Sites (1)

ABH Services PLC

Addis Ababa, Ethiopia

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert Black, MD, MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Agbessi Amouzou, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 25, 2012
• Study Start: December 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

ET (1)