Clinical trial NCT05807269: Prevention and Rehabilitation of Stroke in Uganda
Official title: Prevention and Rehabilitation of Stroke in Uganda
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2023-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample from Wasiko and Hoima in Uganda

Brief summary: Stroke is increasing in low-income countries in Africa, and knowledge is lacking on risk factors and how to prevent stroke as well as how to best use the resources for rehabilitation after stroke which are very limited. Knowledge generation within this area is therefore urgently needed. This collaboration between the research group HELD (Health and Everyday Life among people with neurological Disorders), Karolinska Institutet (KI) and the research surveillant site Africa Medical and Behavioral Sciences Organization (AMBSO) population health surveillance (PHS), will create substantial research opportunities to develop and improve prevention and rehabilitation for stroke, which is in line with the sustainable development goals to reduce the prevalence and mortality rates due to NCDs. AMBSO is collecting data from 17 000 households on many potential risk factors for stroke. Questions about stroke primary and secondary prevention of stroke and impact of stroke or need of rehabilitation could be added to the existing questionnaires such as the validated Ugandan version of the Stroke Impact Scale. This is intended to fulfill the aim of the network which is to increase the knowledge of occurrence and consequences of NCDs with a specific focus on stroke, which will be valuable for the development of preventive healthcare policy documents and guidelines for appropriate prevention strategies and rehabilitation interventions.

Research questions in relation to NCDs with focus on stroke prevention and rehabilitation:

* How many cases (prevalence) are reported in the targeted study sites and what is the mortality rate (incidence) that can specifically relate to stroke?
* How does stroke and other NCDs affect and impact the quality of life for persons living in Uganda?
* Which factors impact the recovery process after stroke?
* What sort of rehabilitation is needed in the study areas for persons affected by stroke? In addition, risk factors of stroke such as diabetes and hypertension will be mapped.


Eligibility criteria: Inclusion Criteria:

* Stroke
* Risk factors for stroke: hypertension, diabetes, HIV, malaria, physical inactivity, obesity

Exclusion Criteria:

* Not having had stroke and/or having no risk factor for stroke

Primary outcomes:
measure: Stroke Impact Scale-16
timeFrame: At one assessment point during 2023-2024
measure: Stroke Impact Scale, perceived recovery
timeFrame: At one assessment point during 2023-2024
Secondary outcomes:
measure: Life Satisfaction Checklist (LISat-11)
timeFrame: At one assessment point during 2023-2024
measure: Patient Health Questionnaire-9
timeFrame: At one assessment point during 2023-2024
measure: Generalized Anxiety Disorder Assessment-7
timeFrame: At one assessment point during 2023-2024
measure: Health Literacy Questionnaire
timeFrame: At one assessment point during 2023-2024
measure: Use of health care services
timeFrame: At one assessment point during 2023-2024
measure: Question about quality of life
timeFrame: At one assessment point during 2023-2024
Other outcomes:
Locations:
city: Hoima
country: Uganda
facility: AMBSO, Hoima
city: Kampala
country: Uganda
facility: AMBSO, Wakiso
Study officials:
affiliation: Karolinska Institutet
name: Gunilla Eriksson, PhD
role: PRINCIPAL_INVESTIGATOR
References: