NCT07773038

Brief Summary

This cross-sectional observational study aims to investigate the association between digital health literacy and social participation in individuals with hemiplegia after stroke. A total of 250 adults with a history of stroke at least 6 months previously will be included. Digital health literacy will be assessed using the eHealth Literacy Scale (eHEALS), and social participation will be assessed using the Reintegration to Normal Living Index (RNLI). The secondary aim is to examine the associations of digital health literacy with anxiety and depression, functional independence, and fatigue.

Trial Health

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Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Aug 2026Feb 2027

First Submitted

Initial submission to the registry

August 14, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 28, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 14, 2026

Last Update Submit

August 14, 2026

Conditions

Keywords

Digital Health LiteracySocial ParticipationStroke RehabilitationHemiplegiaeHealth LiteracyCommunity ReintegrationFunctional Independence

Outcome Measures

Primary Outcomes (1)

  • Social Participation Assessed by the Reintegration to Normal Living Index

    Social participation will be assessed using the Reintegration to Normal Living Index (RNLI). The RNLI consists of 11 items evaluating reintegration into daily activities, family roles, social relationships, and community life. The total score ranges from 0 to 110, with higher scores indicating better reintegration and social participation.

    At the single study assessment (Day 1)

Secondary Outcomes (5)

  • Digital Health Literacy Assessed by the eHealth Literacy Scale

    At the single study assessment (Day 1)

  • Anxiety Symptoms Assessed by the Hospital Anxiety and Depression Scale

    At the single study assessment (Day 1)

  • Depressive Symptoms Assessed by the Hospital Anxiety and Depression Scale

    At the single study assessment (Day 1)

  • Functional Independence Assessed by the Barthel Index

    At the single study assessment (Day 1)

  • Fatigue Assessed by the Fatigue Severity Scale

    At the single study assessment (Day 1)

Study Arms (1)

Individuals With Post-Stroke Hemiplegia

Adults with hemiplegia following stroke who meet the eligibility criteria will undergo a single cross-sectional assessment of digital health literacy, social participation, anxiety and depressive symptoms, functional independence, fatigue, and cognitive status. No study-specific intervention will be administered.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adults with hemiplegia following stroke who receive care at the Physical Medicine and Rehabilitation outpatient clinic, inpatient service, or rehabilitation unit of Afyonkarahisar Health Sciences University. Eligible participants will have a history of stroke at least 6 months before enrollment, be able to communicate and complete the study assessments, and have a Mini-Mental State Examination score of 24 or higher. Both female and male participants will be included.

You may qualify if:

  • Age 18 years or older Diagnosis of hemiplegia following stroke History of stroke at least 6 months before enrollment Ability to communicate sufficiently to complete the study assessments Mini-Mental State Examination score of 24 or higher Ability and willingness to provide written informed consent

You may not qualify if:

  • Severe aphasia preventing completion of the assessments Advanced cognitive impairment Severe psychiatric disorder that may interfere with participation or completion of the assessments Visual or hearing impairment that prevents completion of the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03032, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ersin Beştaş, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 19, 2026

Study Start

August 28, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations