ClinicalTrials.gg
Not yet recruitingNCT07773038Updated Aug 19, 2026

Digital Health Literacy and Social Participation in Individuals With Hemiplegia

An observational study in Stroke and Hemiplegia, sponsored by Afyonkarahisar Health Sciences University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Afyonkarahisar Health Sciences University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Stroke
  • Hemiplegia

Keywords

  • Digital Health Literacy
  • Social Participation
  • Stroke Rehabilitation
  • Hemiplegia
  • eHealth Literacy
  • Community Reintegration
  • Functional Independence
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 250 is above the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Afyonkarahisar Health Sciences University is the lead sponsor of 115 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 score of 24 or higher Ability and willingness to provide written

Exclusion criteria

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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
250 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

07

Study locations

1 site
  • Afyonkarahisar Health Sciences University
    Afyonkarahisar, 03032, Turkey (Türkiye)
    • Ersin Beştaş, MD · Contactersinbestas26@gmail.com · +90 506 889 32 66
    • Ersin Beştaş, MD · Contactersinbestas26@gmail.com
    • Ülkü Demir, MD · Sub investigator
    • Elif Dikmen, MD · Sub investigator
    • Ümit Dündar, MD · Sub investigator
    • Hasan Toktaş, MD · Sub investigator
    • Selma Eroğlu, MD · Sub investigator
    • Sevda Adar, MD · Sub investigator
    • Nuran Eyvaz, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07773038
Responsible party
Ersin Beştaş (MD, Afyonkarahisar Health Sciences University) — Principal investigator
First posted
Aug 19, 2026
Start date
Aug 28, 2026 (estimated)
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Ersin Beştaş, MD
Contact
ersinbestas26@gmail.com
+90 506 889 32 66
Ersin Beştaş, MD
principal investigator · Afyonkarahisar Health Sciences University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion