NCT05807269

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

2.4 years

First QC Date

March 13, 2023

Last Update Submit

April 10, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Stroke Impact Scale-16

    Questionnaire comprising 16 statements concerning perceived impact of stroke. Each item is rated on a scale from 0 (high impact) to 5 (no impact).

    At one assessment point during 2023-2024

  • Stroke Impact Scale, perceived recovery

    Perceived recovery after stroke is rated on a visual analogue scale ranging from 0 (no recovery) to 100 (full recovery).

    At one assessment point during 2023-2024

Secondary Outcomes (6)

  • Life Satisfaction Checklist (LISat-11)

    At one assessment point during 2023-2024

  • Patient Health Questionnaire-9

    At one assessment point during 2023-2024

  • Generalized Anxiety Disorder Assessment-7

    At one assessment point during 2023-2024

  • Health Literacy Questionnaire

    At one assessment point during 2023-2024

  • Use of health care services

    At one assessment point during 2023-2024

  • +1 more secondary outcomes

Study Arms (1)

People with stroke

Participants with stroke or risk factors for stroke

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample from Wasiko and Hoima in Uganda

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AMBSO, Hoima

Hoima, Uganda

RECRUITING

AMBSO, Wakiso

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gunilla Eriksson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gunilla Eriksson, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 13, 2023

First Posted

April 11, 2023

Study Start

November 1, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations