PneumoniaNCT03176914
Testing the Effectiveness of a Modified Community Model in Improving Child Health Outcomes in Mashonaland East, Zimbabwe
A study testing prevention and management of childhood illnesses at community level and conventional community interventions in people with Pneumonia and Diarrhea, run by University of Zimbabwe at 1 site in Zimbabwe.
Trial summary
This study modified and contextualized a community mobilization approach in a bid to find a solution to reduce the high incidence and prevalence of child morbidity and mortality in Zimbabwe.The developed model will be tested for its effectiveness in reducing child morbidity and mortality at community level by… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Diarrhea, Malnutrition
- What is being tested?
- prevention and management of childhood illnesses at community level and conventional community interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 765 participants
- Where
- 1 siteZimbabwe
- Study dates
- 19 Jan 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant and lactating women staying in the study area with children below 4 years
Who cannot join
- Women of child bearing age who do not dwell permanently in the study area
- Women who are very ill and mentally challenged
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Effectiveness of a Modified Care Group Model in Improving Child Health Outcomes in Mashonaland East, Zimbabwe
This study modified and contextualized a community mobilization approach in a bid to find a solution to reduce the high incidence and prevalence of child morbidity and mortality in Zimbabwe.The developed model will be tested for its effectiveness in reducing child morbidity and mortality at community level by comparing the effect of the intervention to that of the conventional community interventions.
Read the detailed description
In Zimbabwe the Neonatal and infant mortality rate are 31/1000 and 57/1000 respectively (ZDHS, 2011). Seventy -four percent of these death occur at community level due to the delay in deciding to seek care . The government of Zimbabwe has intensified facility based health systems though very little has been done in community health system strengthening yet there is glaring evidence from recent studies that the burden of infant and child morbidity and mortality is largely at community level. The effect of social mobilization approaches in reducing socio-cultural causes of morbidity and mortality is not known. Evidence base for participatory models and their effectiveness remains scanty and in-country, there is no approved , integrated community mobilization model that achieves saturation coverage in addressing all facets of community maternal newborn and child health along the continuum of care. Community immersion with health services is in line with the Alma Ata Declaration of the Primary Health Care approach that seeks to decentralize health services to the marginalized people. The study will test the effectiveness of the contextualized model in improving child health outcomes.
A cluster randomized controlled design will be used in 2 randomly selected districts of Mashonaland East , Zimbabwe. Women 18- 49 years with children 0-48 months in the selected districts will be recruited and followed up for 9-12 months . Stratified randomization will be used to select 11 pairs of participating villages . Central randomization will be employed for allocation concealment . The sample size was calculated in STATA 13. assuming a morbidity prevalence of 50% with a margin error of 5%. The assumed intra-cluster correlation coefficient (ICC) of 0.05 with a level of significance of 5% , design effect of 2.45 and power of 0.9. The sample size per arm will be 330 mother-child pairs and each arm will have 11 clusters.
Data will be collected monthly using monthly data collection tools. The study will require participants to commit at most 2 hours once in every two weeks. The main intervention is provision of critical health education and targeted promotion services to the participants in their locality. Participatory approaches will be employed in the intervention arm for learning and sharing of good community IMNCI practices for the prevention and management of childhood illnesses. Participants will be motivated through learning exchange visits and provision of promotional materials as incentives for successful completion and practice of recommended behaviors and child care practices.
- Conditions
- Pneumonia, Diarrhea, Malnutrition, Fever
- Being tested
- prevention and management of childhood illnesses at community level, conventional community interventions
- Keywords
- Community mobilisation
- Medical subject headings
- Pneumonia, Diarrhea, Malnutrition, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prevention and management of childhood illnesses at community levelBehavioural
provision of critical health education and targeted promotion services to the participants in their locality
conventional community interventionsBehavioural
community health programs as the sole source of health education
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Eleven clusters (Villages) will be randomly selected. A cluster will comprises of 10-15 volunteers selected from a cohort 10-15 households. Educative sessions will be held in each cluster once every fortnight using a participatory methods by a trained Village Health Worker (VHW). A session will focus on one thematic area running for 1-2 hours. Trained volunteers will in turn replicate the session(s) in their cohorts and do home visits to monitor care practices and screen children for various ailment. Health information is collated from each cluster and consolidated by the VHW who reports monthly at the clinic. Receives: Behavioral: prevention and management of childhood illnesses at community level |
| Conventional Intervention arm | Active comparator | In the conventional mobilization system, a Village Health Worker facilitates community health programs as the sole source of health education for the entire villages. She does home visits, child growth monitoring and the various components primary health care at village level inclusive of disease surveillance and community case management using the 'supermarket approach' , whereby 3 or more themes are covered in a space of 10- 30 minutes in functions like funerals, village gatherings and other opportune moments. The Village Health worker prepares village monthly reports on all the indicators on community health and submits to the local health centre. Receives: Behavioral: conventional community interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in child morbidity
Incidence of childhood illnesses
Measured: 9- 12 months
Secondary outcomes (4)
Early ANC uptake
Number of women who booked in the first trimester
Measured: 3 Months
Institutional deliveries
Proportion of women with children 0-48 months who delivered at a health facility
Measured: 3 months
Postnatal care uptake
Proportion of women with a child 0 -48 months who received post-natal care in their last delivery
Measured: 3 months
Knowledge levels on child care
Proportion of women with a child 0-48 months who have basic knowledge on dangers signs and management of childhood illnesses
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start19 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will have an intervention arm under which the study intervention will be implemented and this will be compared with the outcomes in the conventional intervention arm. Each arm will have 11 clusters of an average size of 50.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- Collaborators
- NORHED
- Responsible party
- Principal investigator, Maxwell Mhlanga, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176914
- Sponsor's protocol ID
- MRCZ/A/2099
- Status last verified
- Mar 2019
- First submitted
- 24 May 2017
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of a Modified Care Group Model in Improving Child Health Outcomes in Mashonaland East, Zimbabwe
- ClinicalTrials.gov ID
- NCT03176914
- Acronym / sponsor ID
- MRCZ/A/2099
- Conditions
- Pneumonia, Diarrhea, Malnutrition, Fever
- Keywords
- Community mobilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- Collaborators
- NORHED
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study modified and contextualized a community mobilization approach in a bid to find a solution to reduce the high incidence and prevalence of child morbidity and mortality in Zimbabwe.The developed model will be tested for its effectiveness in reducing child morbidity and mortality at community level by comparing the effect of the intervention to that of the conventional community interventions.
Detailed description
In Zimbabwe the Neonatal and infant mortality rate are 31/1000 and 57/1000 respectively (ZDHS, 2011). Seventy -four percent of these death occur at community level due to the delay in deciding to seek care . The government of Zimbabwe has intensified facility based health systems though very little has been done in community health system strengthening yet there is glaring evidence from recent studies that the burden of infant and child morbidity and mortality is largely at community level. The effect of social mobilization approaches in reducing socio-cultural causes of morbidity and mortality is not known. Evidence base for participatory models and their effectiveness remains scanty and in-country, there is no approved , integrated community mobilization model that achieves saturation coverage in addressing all facets of community maternal newborn and child health along the continuum of care. Community immersion with health services is in line with the Alma Ata Declaration of the Primary Health Care approach that seeks to decentralize health services to the marginalized people. The study will test the effectiveness of the contextualized model in improving child health outcomes.
A cluster randomized controlled design will be used in 2 randomly selected districts of Mashonaland East , Zimbabwe. Women 18- 49 years with children 0-48 months in the selected districts will be recruited and followed up for 9-12 months . Stratified randomization will be used to select 11 pairs of participating villages . Central randomization will be employed for allocation concealment . The sample size was calculated in STATA 13. assuming a morbidity prevalence of 50% with a margin error of 5%. The assumed intra-cluster correlation coefficient (ICC) of 0.05 with a level of significance of 5% , design effect of 2.45 and power of 0.9. The sample size per arm will be 330 mother-child pairs and each arm will have 11 clusters.
Data will be collected monthly using monthly data collection tools. The study will require participants to commit at most 2 hours once in every two weeks. The main intervention is provision of critical health education and targeted promotion services to the participants in their locality. Participatory approaches will be employed in the intervention arm for learning and sharing of good community IMNCI practices for the prevention and management of childhood illnesses. Participants will be motivated through learning exchange visits and provision of promotional materials as incentives for successful completion and practice of recommended behaviors and child care practices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will have an intervention arm under which the study intervention will be implemented and this will be compared with the outcomes in the conventional intervention arm. Each arm will have 11 clusters of an average size of 50.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: prevention and management of childhood illnesses at community levelEleven clusters (Villages) will be randomly selected. A cluster will comprises of 10-15 volunteers selected from a cohort 10-15 households. Educative sessions will be held in each cluster once every fortnight using a participatory methods by a trained Village Health Worker (VHW). A session will focus on one thematic area running for 1-2 hours. Trained volunteers will in turn replicate the session(s) in their cohorts and do home visits to monitor care practices and screen children for various ailment. Health information is collated from each cluster and consolidated by the VHW who reports monthly at the clinic. |
| Conventional Intervention arm | Active comparator | Behavioral: conventional community interventionsIn the conventional mobilization system, a Village Health Worker facilitates community health programs as the sole source of health education for the entire villages. She does home visits, child growth monitoring and the various components primary health care at village level inclusive of disease surveillance and community case management using the 'supermarket approach' , whereby 3 or more themes are covered in a space of 10- 30 minutes in functions like funerals, village gatherings and other opportune moments. The Village Health worker prepares village monthly reports on all the indicators on community health and submits to the local health centre. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant and lactating women staying in the study area with children below 4 years
Key exclusion criteria (2 listed)
- Women of child bearing age who do not dwell permanently in the study area
- Women who are very ill and mentally challenged
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prevention and management of childhood illnesses at community levelprovision of critical health education and targeted promotion services to the participants in their locality | Behavioural | Intervention arm |
| conventional community interventionscommunity health programs as the sole source of health education | Behavioural | Conventional Intervention arm |
Primary outcome
Reduction in child morbidity
Time frame: 9- 12 months
Incidence of childhood illnesses
4 secondary outcomes
Early ANC uptake
Time frame: 3 Months
Institutional deliveries
Time frame: 3 months
Postnatal care uptake
Time frame: 3 months
Knowledge levels on child care
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prevention and management of childhood illnesses at community level and conventional community interventions in people with Pneumonia and Diarrhea, run by University of Zimbabwe at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in child morbidity (time frame: 9- 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.