Evaluation of Integrated Community Case Management in Ethiopia

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Canadian International Development Agency
UNICEF
Information provided by (Responsible Party):
Robert Black, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01606267
First received: May 18, 2012
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Pneumonia
Other: health systems intervention: HEP+ICCM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Independent Prospective Evaluation of Integrated Community Case Management and Development and Implementation of a Method for Real-time Mortality Monitoring in the Oromia Region, Ethiopia

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Mortality rate among children under-five (0-59 months) [ Time Frame: Over a 12 and 18 month period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality rate among children 1-59 months [ Time Frame: Over a 12 and 18 month period ] [ Designated as safety issue: No ]
  • Malnutrition of under-five children (wasting, stunting and underweight rates) [ Time Frame: Measured at 0 and 18 months ] [ Designated as safety issue: No ]
  • Treatment coverage of childhood diarrhea, malaria, pneumonia and malnutrition [ Time Frame: Measured at 0 and 18 months ] [ Designated as safety issue: No ]
  • Care-seeking coverage for childhood diarrhea, malaria, pneumonia and malnutrition [ Time Frame: Measured at 0 and 18 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Measured once at 10 months (midterm) ] [ Designated as safety issue: No ]

Estimated Enrollment: 607770
Study Start Date: December 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Routine HEP
This arm includes routine care provided under the health extension program provided to rural Ethiopian villages with limited access to health facilities.
Experimental: HEP+ICCM
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
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606267

Locations
Ethiopia
ABH Services PLC
Addis Ababa, Ethiopia
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Canadian International Development Agency
UNICEF
Investigators
Principal Investigator: Robert Black, MD, MPH Johns Hopkins School of Public Health
Principal Investigator: Agbessi Amouzou, PhD Johns Hopkins School of Public Health
  More Information

No publications provided

Responsible Party: Robert Black, Edgar Berman Professor and Chair, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01606267     History of Changes
Other Study ID Numbers: Grant # 109947
Study First Received: May 18, 2012
Last Updated: May 24, 2012
Health Authority: United States: Institutional Review Board
Ethiopia: Ethical Review Committee

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Integrated Community Case Management
Pneumonia
Ethiopia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 21, 2014