ICCM of Common Childhood Diseases: Mozambique and Uganda (inSCALE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Malaria Consortium, UK
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
University College, London
Karolinska Institutet
Makerere University
Information provided by (Responsible Party):
Malaria Consortium, UK
ClinicalTrials.gov Identifier:
NCT01810055
First received: March 7, 2013
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

The aim of the inSCALE project is to test the effect of innovative approaches to increase coverage of integrated community case management, which provides community based-care for diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate care for these three most common childhood illnesses


Condition Intervention
Malaria
Pneumonia
Diarrhoea
Other: inSCALE mobile CHW support system
Behavioral: Village Health Clubs
Other: Integrated Community Case Management (ICCM)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Integrated Community Case Management of Common Childhood Diseases: Mozambique and Uganda

Resource links provided by NLM:


Further study details as provided by Malaria Consortium, UK:

Primary Outcome Measures:
  • Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age [ Time Frame: The primary outcome measure will be evaluated 12 months after intervention implementation, ie around April 2014 ] [ Designated as safety issue: No ]
    Proportion of children under five years of age with symptoms of malaria, pneumonia and diarrhoea who received appropriate treatment


Secondary Outcome Measures:
  • Community health worker stock outs [ Time Frame: The secondary outcome measure will be evaluated 12 months after intervention implementation, ie around April 2014 ] [ Designated as safety issue: No ]
    The proportion of community health workers with medicine stock-out <1 week each quarter


Other Outcome Measures:
  • Cost per CHW retained [ Time Frame: All other outcome measures will be evaluated 12 months after intervention implementation, ie around April 2014 ] [ Designated as safety issue: No ]
    The cost per CHW retained over 1 and 2 years of implementation in the 3 arms


Estimated Enrollment: 2500
Study Start Date: November 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Technology arm
The inSCALE technology supported approach will support the CHWs in providing quality case management for the under-fives who suffer from diarrhea, pneumonia and malaria through unlimited communication with their health facility supervisors and colleagues through closed-user-groups. It will enhance timely reporting of patient data and targeted support supervision on the CHWs who need support from their supervisors. With the CHWs receiving the above support and feedback messages, this will potentially increase CHW motivation, performance and retention. Data reported by CHWs can be used by the district planners to forecasting of medicine procurements and react to drug stock-outs or unusual data trends (e.g. disease outbreaks).
Other: inSCALE mobile CHW support system

CHWs will be provided with mobile phones and solar chargers to carry out the following:

Activity 1: Establish closed user groups (CUGs) to enable two-way communication between CHWs and their supervisors free of charge to the users.

Activity 2:

  1. Data submission by CHWs through mobile phones and motivational performance related feedback provided in response.
  2. Automated messages to supervisors

i. flagging any problems and strengths/successes identified in CHWs data submitted using provided phones, ii. Alerting supervisors as to which CHWs require targeted supervision. c. CHWs submitted data summarised in a user friendly format and made accessible to district statisticians for analysis and feedback to supervisors on problems and strengths/successes identified.

Activity 3: Monthly motivational SMS messages provided to CHWs that are locally relevant to CHW work and that are designed to impact positively on CHW performance.

Other: Integrated Community Case Management (ICCM)
Implementation of integrated community case management, with provision of training and equipment to CHWs for diagnosis and treatment of malaria, pneumonia and diarrhoea in children less than 5 years of age. Supportive supervision of CHWs will be provided by assigned health facility supervisor.
Experimental: Community arm
The village health clubs aim to improve child health through a community led forum with the CHW as the main focus point. Village health club meetings will provide a forum where CHWs and community members who are part of the club can work together to identify child health and CHW challenges. They will use village networks, knowledge, creativity and other assets
Behavioral: Village Health Clubs
CHWs will facilitate the clubs using a learning, planning and action cycle. Health club members will rank child health challenges faced by their community using picture cards and decide which one to focus on for each of the cycles. They will discuss solutions, which include supporting CHWs services, and take actions to meet these challenges. They will also promote group decision-making and ownership and through this process gain tangible results. Solutions to village health challenges developed by village members are a key focus of the village health club approach. Village Health Clubs are based on 5 guiding principles which will inspire community members to pull together and act, and encourage members and community leaders to use the clubs for the purpose they are intended: clubs are open to all, village owned, intended to support CHW work, strength based, and fun and focused.
Other: Integrated Community Case Management (ICCM)
Implementation of integrated community case management, with provision of training and equipment to CHWs for diagnosis and treatment of malaria, pneumonia and diarrhoea in children less than 5 years of age. Supportive supervision of CHWs will be provided by assigned health facility supervisor.
Active Comparator: Control arm
The CHWs in the control arm will be receiving the standard Ministry of Health designed package to integrated community case management support and supervision.
Other: Integrated Community Case Management (ICCM)
Implementation of integrated community case management, with provision of training and equipment to CHWs for diagnosis and treatment of malaria, pneumonia and diarrhoea in children less than 5 years of age. Supportive supervision of CHWs will be provided by assigned health facility supervisor.

Detailed Description:

The Innovations at Scale for Community Access and Lasting Effects (inSCALE) project is identifying and documenting limitations to national scale up of Integrated Community Case Management (ICCM) and aims to demonstrate that coverage and impact of government-led ICCM programmes can be extended if innovative solutions can be found for critical limitations. Based on research, three main constraints have been found to limit coverage of community based management of childhood diseases: supervision, motivation and information flow.

Potential solutions to the identified constraints have been formulated based on current knowledge and experiences from Malaria Consortium ICCM implementation and other relevant community-based initiatives in both project countries and elsewhere. Extensive formative research was conducted to support the design of innovations aimed to improve motivation and performance of community health workers.

Innovations which have potential to address the project's aims but lack sufficient evidence of impact are being formally evaluated in a randomised control trial. In Mozambique, a technology based intervention is being tested where community health workers (CHWs) are provided with smart phones to programmed with a tool for decision support, immediate feedback and multimedia audio and images to improve adherence to protocols. The tool will also allow CHWs to send key indicators to a server and to keep a register of patients who can be tracked over time. The indicators submitted will be used for performance monitoring of the CHWs by providing automated timely, digestible reports with targeted follow-up actions for CHW supervisors. In Uganda, one technology and one community based intervention are being evaluated over a 12 month period. In the technology intervention, CHWs are given a Java enabled mobile phone through which they can send their weekly reports and drug stocks, receive immediate feedback based on data submission and monthly motivational messages. The phones in both countries also contain innovative tools such as a respiratory timers to support the CHWs in their work. CHWs and their supervisors are on closed user groups in order to increase communication and support. The community intervention is focused on the running of Village Health Clubs. These are designed to be highly participatory with the CHWs in the role of facilitator, aimed at increasing awareness about the CHW role and improving motivation through the support of the community.

Continuous Ministry of Health support for health facilities to provide referral care and equip community health workers with medicines, tools, supervision and training are critical for the success of the project

  Eligibility

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

Inclusion Criteria:

  • Residents in randomly selected clusters in the study area

Exclusion Criteria:

  • N/A
  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: NCT01810055

Contacts
Contact: Karin Källander, PhD +256773744126 k.kallander@malariaconsortium.org
Contact: James Tibenderana, PhD +265772744052 j.tibenderana@malariaconsortium.org

Locations
Uganda
Malaria Consortium Africa Recruiting
Kampala, Uganda
Contact: Karin Källander, PhD    +256772744126    k.kallander@malariaconsortium.org   
Principal Investigator: Karin Källander, PhD         
Sponsors and Collaborators
Malaria Consortium, UK
London School of Hygiene and Tropical Medicine
University College, London
Karolinska Institutet
Makerere University
Investigators
Study Director: Sylvia Meek, PhD Malaria Consortium, UK
Principal Investigator: James Tibenderana, PhD Malaria Consortium Africa, Uganda
  More Information

Additional Information:
Publications:
Responsible Party: Malaria Consortium, UK
ClinicalTrials.gov Identifier: NCT01810055     History of Changes
Other Study ID Numbers: OPP1002407
Study First Received: March 7, 2013
Last Updated: March 11, 2013
Health Authority: Uganda: National Council of Science and Technology
Mozambique: Comité Nacional de Bioética para a Saúde, Ministry of Health (MISAU)

Keywords provided by Malaria Consortium, UK:
Community health worker
Motivation
Performance
Retention
Uganda
Mozambique

Additional relevant MeSH terms:
Diarrhea
Malaria
Pneumonia
Signs and Symptoms, Digestive
Signs and Symptoms
Protozoan Infections
Parasitic Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 31, 2014