Skip to content

Scaling-up packages of interventions for cardiovascular disease prevention in selected sites in Europe and sub-Saharan Africa: an implementation research (SPICES Project)

An Implementation science study to enhance cardiovascular disease prevention in Mukono and Buikwe districts in Uganda: a stepped-wedge design

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15848572
Enrollment
4000
Registered
2019-01-23
Start date
2018-12-10
Completion date
Unknown
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease risk factors Circulatory System

Interventions

Packages of interventions along the cascade (community and health facility levels) classified under four work packages: health promotion/education
CVD risk profiling
care and management
and self-management & follow-up. The trialists propose to draw lessons from the HIV response in combination with the Innovative Care for Chronic Conditions (ICCC) framework to impleme
guidelines and standardized treatment protocols
and improving data capture by provision of computer/digital devices
and training personnel in prevention and management of CVD risk factors and patient provider relationships. Health workers in these facilities will be trained. Current materials developed by the Minis

Sponsors

Makerere University School of Public Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Both male and female 2. Aged 18 years and above 3. Consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. The mentally ill will not be included in the evaluations 2. Non consenting adults

Design outcomes

Primary

MeasureTime frame
1. Reach: proportion of the health care/community providers/target population approached; uptake of intervention packages; and proportion of adherent. Measured by analysis of routine data generated by CHW, peers & health facilities and individual/patient quantitative assessments using household/patient questionnaires at 0, 6, 12, 18 and 24 months 2. Appropriateness: 2.1. The extent to which proposed interventions can be delivered at health facilities/community, measured using individual interviews, focus group discussion and key informant interviews at 0, 6, 12, 18 and 24 months 2.2. Organizational readiness: availability and functionality of infrastructure including personnel, equipment, supplies etc. measured using the health facility readiness and capacity assessment questionnaire at 0, 6, 12, 18 and 24 months 2.3. Linkage to healthcare: self-report using h/h questionnaire, data extraction checklist at 12 and 24 months 2.4. Referrals for task sharing/shifting: data extraction checklist at 12 and 24 months 3. Acceptability: user and provider feedback, focus group discussion guides, key informants (formative process ongoing); individual/patient satisfaction (needs) assessed using Patient Satisfaction Questionnaire at 12 and 24 months 4. Self-efficacy: personal beliefs about own competencies to achieve implementation goals, assessed using provider questionnaire, pre/post training assessment tools at 12 and 24 months 5. Adoption: implementation of the project and challenges to implementation (barriers and opportunities and coping mechanisms), assessed using focus group discussions, individual interviews and key informant interviews at 0, 6, 12, 18 and 24 months (formative process ongoing) 6. Cost: Costs associated with implementing the packages, assessed using checklists for cost data (health facility cost dat

Secondary

MeasureTime frame
Risk factors/clinical profiles e.g. blood pressure, BMI, alcohol history, smoking status, assessed using household questionnaire adapted with modification to suit local context from several standardised questionnaires – WHO steps survey, international physical activity questionnaire (IPAC), EuroQual EQ 5D 5L, and the Uganda Demographic survey questionnaire. Assessed at 0, 6, 12, 18 and 24 months

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026