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NCT Number: NCT07773038

Digital Health Literacy and Social Participation in Individuals With Hemiplegia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03032, Turkey (Türkiye)

Location contact

Elif Dikmen, MD

SUB_INVESTIGATOR

Ersin Beştaş, MD

CONTACT

[email protected]

+90 506 889 32 66

Ersin Beştaş, MD

CONTACT

[email protected]

Hasan Toktaş, MD

SUB_INVESTIGATOR

Nuran Eyvaz, MD

SUB_INVESTIGATOR

Selma Eroğlu, MD

SUB_INVESTIGATOR

Sevda Adar, MD

SUB_INVESTIGATOR

Ülkü Demir, MD

SUB_INVESTIGATOR

Ümit Dündar, MD

SUB_INVESTIGATOR

About this study

Stroke-related hemiplegia may affect not only motor function and independence in activities of daily living but also individuals' ability to participate in family, social, and community life. With the increasing use of online health information, mobile health applications, and electronic health services, digital health literacy may play an important role in access to health information, self-management, and engagement in rehabilitation.

This study is designed as a single-center, cross-sectional observational study. It will include 250 adults aged 18 years or older who have hemiplegia following a stroke that occurred at least 6 months previously. Participants must be able to communicate, provide written informed consent, and have a Mini-Mental State Examination score of 24 or higher.

Sociodemographic and clinical characteristics, including age, sex, education level, employment status, stroke duration, affected side, assistive device use, functional ambulation level, smartphone use, internet use, and use of electronic health services, will be recorded.

Digital health literacy will be evaluated using the eHealth Literacy Scale (eHEALS). Social participation, the primary outcome of the study, will be evaluated using the Reintegration to Normal Living Index (RNLI). Anxiety and depressive symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), functional independence using the Barthel Index, fatigue using the Fatigue Severity Scale (FSS), and cognitive status using the Mini-Mental State Examination.

The primary analysis will examine the association between the eHEALS total score and the RNLI total score. Multiple linear regression analysis will be used to investigate whether digital health literacy is independently associated with social participation after accounting for relevant sociodemographic and clinical variables.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Social Participation Assessed by the Reintegration to Normal Living Index

    Time frame: At the single study assessment (Day 1)

    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.

Secondary outcomes

  1. Digital Health Literacy Assessed by the eHealth Literacy Scale

    Time frame: At the single study assessment (Day 1)

    Digital health literacy will be assessed using the eHealth Literacy Scale (eHEALS). The scale consists of 8 items rated on a 5-point Likert scale. The total score ranges from 8 to 40, with higher scores indicating greater perceived digital health literacy.

  2. Anxiety Symptoms Assessed by the Hospital Anxiety and Depression Scale

    Time frame: At the single study assessment (Day 1)

    Anxiety symptoms will be assessed using the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale score ranges from 0 to 21, with higher scores indicating greater anxiety symptom severity.

  3. Depressive Symptoms Assessed by the Hospital Anxiety and Depression Scale

    Time frame: At the single study assessment (Day 1)

    Depressive symptoms will be assessed using the 7-item depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale score ranges from 0 to 21, with higher scores indicating greater depressive symptom severity.

  4. Functional Independence Assessed by the Barthel Index

    Time frame: At the single study assessment (Day 1)

    Functional independence in activities of daily living will be assessed using the Barthel Index. The total score ranges from 0 to 100, with higher scores indicating greater functional independence.

  5. Fatigue Assessed by the Fatigue Severity Scale

    Time frame: At the single study assessment (Day 1)

    Fatigue will be assessed using the Fatigue Severity Scale (FSS), which consists of 9 items rated from 1 to 7. The mean score ranges from 1 to 7, with higher scores indicating greater fatigue severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Ersin Beştaş, MD

CONTACT

[email protected]

+90 506 889 32 66

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

The Association Between Digital Health Literacy and Social Participation in Individuals With Hemiplegia: A Cross-Sectional Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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