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Sustainable model for Cardiovascular health by Adjusting Lifestyle and treatment with Economic perspective in settings of Urban Poverty, A community-based intervention for primary prevention of cardiovascular diseases in the slums of Nairobi

KENYA, 2012 - 2014
Health and Well-Being (HaW)
African Population and Health Research Center
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Identification

IDNO
APHRC-SCALEUP-2014-1.0
Title
Sustainable model for Cardiovascular health by Adjusting Lifestyle and treatment with Economic perspective in settings of Urban Poverty, A community-based intervention for primary prevention of cardiovascular diseases in the slums of Nairobi
Subtitle
A community-based intervention for primary prevention of cardiovascular diseases in the slums of Nairobi
Translated Title
English
Country
Name Country code
KENYA KEN
Abstract
Background: The burden of cardiovascular disease is rising in sub-Saharan Africa with hypertension being the main

risk factor. However, context-specific evidence on effective interventions for primary prevention of cardiovascular diseases in resource-poor settings is limited. This study aims to evaluate the feasibility and cost-effectiveness of one such intervention-the “Sustainable model for cardiovascular health by adjusting lifestyle and treatment with economic perspective in settings of urban poverty”.



Methods/Design: Design: A prospective quasi-experimental community-based intervention study.



Setting: Two slum settlements (Korogocho and Viwandani) in Nairobi, Kenya.



Study population: Adults aged 35 years and above in the two communities.

Intervention: The intervention community (Korogocho) will be exposed to an intervention package for primary prevention of cardiovascular disease that comprises awareness campaigns, household screening for cardiovascular diseases risk factors, and referral and treatment of people with high cardiovascular diseases risk at a primary health clinic. The control community (Viwandani) will continue accessing the usual standard of care for primary prevention of cardiovascular diseases in Kenya.



Data: Demographic and socioeconomic data; anthropometric and clinical measurements including blood pressure. Population-based data will be collected at the baseline and endline-12 months after implementing the intervention. These data will be collected from a random sample of 1,610 adults aged 35 years and above in the intervention and control sites at both baseline and endline. Additionally, operational (including cost) and clinic-based data will be collected on an ongoing basis.



Main outcomes:

(1) A positive difference in the change in the proportion of the intervention versus control study populations that are at moderate or high risk of cardiovascular disease;

(2) a difference in the change in mean systolic blood pressure in the intervention versus control study populations;

(3) the net cost of the complete intervention package per disability-adjusted life year gained.

Analysis: Primary outcomes comparing pre- and post-, and operational data will be analyzed descriptively and “impact” of the intervention will be calculated using double-difference methods. We will also conduct a cost-effectiveness analysis of the intervention using World Health Organization guidelines

Version

Version Date
2015-04-28

Scope

Keywords
Keyword
Prevention
Cost-effectiveness
Cardiovascular risk factors
Slums
Sub-Saharan Africa

Coverage

Geographic Coverage
Korogocho and Viwandani informal settlements in Nairobi
Unit of Analysis
Individuals
Universe
Adults 35 years and above in Korogocho and Viwandani who have given informed consent

Producers and sponsors

Authoring entity/Primary investigators
Agency Name Affiliation
African Population and Health Research Center APHRC
Producers
Name Affiliation Role
Dr Catherine Kyobutungi African Population and Health Research Center Co-Principal Investigator
Dr Joep Lange Amsterdam Institute for Global Health and Development Co-Principal Investigator
Dr. Steven van de Vijver African Population and Health Research Center Investigator
Dr. Samuel Oti African Population and Health Research Center Investigator
Funding Agency/Sponsor
Name Abbreviation Role
Academic Medical Center Amsterdam Foundation (AMC) Funder
Other Identifications/Acknowledgments
Name Affiliation Role
Michiel Heidenrijk, Gabriela G. Gomez; Mark te Pas, Else van Schijndel, Marleen E Hendriks, Zlata Tanovic and Frank van Leth Amsterdam Institute of Global Health and Development Technical Support
Amsterdam Institute of Global Health and Development Financial Support
Moses Mwithiga, Mildred Adhiambo, Frederick Wekesah and Thaddaeus Egondi African Population and Health Research Center Logistical and Scientifc Support
Charles Agyemang, Eric P Moll van Charante, Lizzy M Brewster, Constance Schultsz University of Amsterdam Technical support
Prof. Dr. M. Levi, Prof. Dr. L. Gunning, Mr. H. van Poelvoorde, Prof. Jacques van der Gaag and Dr. Dermot Maher The coaching committee of the SCALE UP Study
Boston Consulting Group (BCG) Developing Cost effectiveness framework
Academic Medical Center (AMC) Foundation Financial Support

Sampling

Sampling Procedure
In order to detect a 5% reduction at endline in the proportion of adults aged 35 years and above who are at moderate or high risk of CVD in the intervention population versus no change in the control population (assuming both populations have similar start prevalence at 25%), we need 2,927 respondents in both intervention and control sites, using an alpha of 0.05 and power (1-beta) of 0.90. Taking into account a non-response rate of 10%, we will approach 3,220 individuals per cross-sectional study-that is, 1,610 per site at baseline and endline surveys, respectively. The sampling frame will be based on the most recently updated NUHDSS database. This database contains details of about 72,000 individuals including names, locations, gender, dates of birth and residential status in both slums. In the control site, we will use computer randomization (STATA® statistical software) to select the 1,610 individuals aged 35 years and older per site for each cross-sectional survey. In the intervention site, the same computer randomization process will be followed. However, unlike the control site, the 1,610 individuals to be included in the cross-sectional survey analysis will be collected retrospectively. In other words, the intervention package will be delivered to all adults aged 35 years or older in the intervention site-that is, 6,780 individuals according to the DSS database (as at 15 June 2012). At the clinic level, we calculated that in order to detect a 10 mmHg reduction in blood pressure (at 20 mmHg standard deviation, alpha of 0.05 and 1-ß on 0.9), about 44 participants are needed. However, it is projected that approximately 1,350 participants (out of 6780) will be referred from the door-to-door visit. This number is derived from a 20% prevalence of hypertension among adults aged 35 years and older in the study area.

We estimate that roughly half of these 1,350 participants, being 675, will continue visiting the clinic for treatment. Hence, this number of people is more than

sufficient for the analysis of our main primary outcome at the clinic level.
Deviations from the Sample Design
No deviation.
Response Rate
Population baseline response rate in Korogocho (intervention) was 56.7% and 40.3% in Viwandani (control)

Population endline response rate was 50.2% in Korogocho (intervention) , 77.0% in Viwandani screened at baseline (first control) and 53.6% in Viwandani not screened (second control)

Data Collection

Dates of Data Collection (YYYY/MM/DD)
Start date End date
2012-08-01 2014-04-30
Mode of data collection
Face-to-face [f2f]
Supervision
The supervision in the field has been managed by the two research officers and executed by the research assistant and the team leaders through spot checks, sit ins, double entry of data, cross checking and regular meetings
Type of Research Instrument
POPULATION:

1. Identification Information And Consent

2. Demographics 3 History Of Chronic Conditions

3. Exposure To Health Promotion And Behavior Change

4. Risk Factors And Preventive Behavior 6 Perceived Personal Risk

5. Anthropometrics And Biomarkers 8 Interviewer Assessment



CLINIC:

1. Identification Information And Consent

2. Clinic History

3. Knowledge Of Prevention / Evaluation Intervention

4. Anthropometrics And Biomarkers

Data access

Contact
Name Affiliation Email URI
Head Statistics and Surveys Unit APHRC info@aphrc.org www.aphrc.org
Conditions
All non-APHRC staff seeking to use data generated at the Center must obtain written approval to use the data from the Director of Research. This form is developed to assess applications for data use and facilitate responsible sharing of data with external partners/collaborators/researchers. By entering into this agreement, the undersigned agrees to use these data only for the purpose for which they were obtained (as outlined on this form) and to abide by the conditions outlined below:

1. Data Ownership: The data remain the property of APHRC; any unauthorized reproduction and sharing of the data is strictly prohibited. The user will, therefore, not release nor permit others to use or release the data to any other person without the written authorization from the Center.

2. Purpose: The provided data must be used for the purpose specified in the Data Request Form; any other use not specified in the form must receive additional or separate authorization.

3. Respondent Identifiers: The Center is committed to protecting the identity of the respondents who provide information in its research. All analytical data sets (both qualitative and quantitative) released by the Data Unit MUST are stripped of respondent identifiers to protect the identity of the respondents. By accepting to use APHRC data, the user is pledging that he/she will not, under any circumstance, regenerate the identifiers or permit others to use the data to learn the identity of any individual, household or community included in any data set.

4. Confidentiality pledge: The user will not use nor permit others to use the data to report any information in the data sets that could identify, directly or by inference, individuals or households.

5. Reporting of errors or inconsistencies: The user will promptly notify the Head of the Statistics and Survey Unit any errors discovered in the data as soon as the errors are discovered.

6. Publications resulting from APHRC data: The Center requires external collaborators to work with APHRC staff on all publications resulting from its data. In order to facilitate this, lead authors should send a detailed concept note of the paper (including the background, rationale, data, analytical methods, and preliminary findings) to the Principle Investigator (or Theme Leader) for the project (with a copy to the Director of Research), who will circulate the abstract to concerned researchers for possible expression of interest in participating in the publication as co-authors. Any exception to the involvement of APHRC staff should be approved by the Director of Research, APHRC.

7. Security: The user will take responsibility for the security of the data by ensuring that the data are used and stored in a secure environment where access is password protected. This will ensure that non-authorized people should not have access to the data.

8. Loss of privilege to use data: In the event that APHRC determines that the data user is in violation of the conditions for using the data, or if the user wishes to cancel this agreement, the user will destroy the data files provided to him/her. APHRC retains the right to revoke this agreement or informs publishers to withhold publication of any work based wholly or in part on its data if the conditions for using the data are violated.

9. Acknowledgement: Any work/reports from this data must acknowledge APHRC as the source of these data. For example, the suggested acknowledgement for NUHDSS data is:

"This research uses livelihoods data collected under the longitudinal Nairobi Urban Health and Demographic Surveillance System (NUHDSS) since 2006. The NUHDSS is carried out by the African Population and Health Research Center in two slums settlements (Korogocho and Viwandani) in Nairobi City."

Additionally all funders, the study communities that provided the data, and staff who collected and analyzed or processed the data should be acknowledged.

10. Deposit of Reports/Papers: The user should submit electronic and paper copies of all publications generated using APHRC data to the Policy Engagement and Communications Department, with copies to the Director of Research.

11. Change of contact details: The user will promptly inform the Director of Research of any change in your personal details as contained on this data request form.
Citation requirement
African Population & Health Research Center, Sustainable model for Cardiovascular health by Adjusting Lifestyle and treatment with Economic perspective in settings of Urban Poverty, April 2015. APHRC, Nairobi, Kenya. doi:11239/176-2014-029-1.0

Metadata production

Document ID
APHRC-SCALEUP-2014-1.0
Producers
Name Abbreviation Role
African Population and Health Research Center APHRC Metadata Producer
Date of Production
2014-12-31
Document version
Version 1.0