StrokeNCT07773038
Digital Health Literacy and Social Participation in Individuals With Hemiplegia
An observational study of Stroke and Hemiplegia, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiplegia
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2026to 28 Feb 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03032
Ersin Beştaş, MD, +90 506 889 32 66, ersinbestas26@gmail.com
Ersin Beştaş, MD, ersinbestas26@gmail.com
About this study
Official title: The Association Between Digital Health Literacy and Social Participation in Individuals With Hemiplegia: A Cross-Sectional Study
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.
Read the detailed description
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.
- Conditions
- Stroke, Hemiplegia
- Keywords
- Digital Health Literacy, Social Participation, Stroke Rehabilitation, Hemiplegia, eHealth Literacy, Community Reintegration, Functional Independence
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the single study assessment (Day 1)
Secondary outcomes (5)
Digital Health Literacy Assessed by the eHealth Literacy Scale
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.
Measured: At the single study assessment (Day 1)
Anxiety Symptoms Assessed by the Hospital Anxiety and Depression Scale
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.
Measured: At the single study assessment (Day 1)
Depressive Symptoms Assessed by the Hospital Anxiety and Depression Scale
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.
Measured: At the single study assessment (Day 1)
Functional Independence Assessed by the Barthel Index
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.
Measured: At the single study assessment (Day 1)
Fatigue Assessed by the Fatigue Severity Scale
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.
Measured: At the single study assessment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start28 Aug 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersin Beştaş, Afyonkarahisar Health Sciences University
- Investigators
- Ersin Beştaş, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773038
- Sponsor's protocol ID
- AFSU-FTR-DHLSP-2026
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Digital Health Literacy and Social Participation in Individuals With Hemiplegia: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07773038
- Acronym / sponsor ID
- AFSU-FTR-DHLSP-2026
- Conditions
- Stroke, Hemiplegia
- Keywords
- Digital Health Literacy, Social Participation, Stroke Rehabilitation, Hemiplegia, eHealth Literacy, Community Reintegration, Functional Independence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Digital Health Literacy Assessed by the eHealth Literacy Scale
Time frame: At the single study assessment (Day 1)
Anxiety Symptoms Assessed by the Hospital Anxiety and Depression Scale
Time frame: At the single study assessment (Day 1)
Depressive Symptoms Assessed by the Hospital Anxiety and Depression Scale
Time frame: At the single study assessment (Day 1)
Functional Independence Assessed by the Barthel Index
Time frame: At the single study assessment (Day 1)
Fatigue Assessed by the Fatigue Severity Scale
Time frame: At the single study assessment (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ersin Beştaş, MD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemiplegia, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ersin Beştaş, MD (+90 506 889 32 66, ersinbestas26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Participation Assessed by the Reintegration to Normal Living Index (time frame: At the single study assessment (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.