Health Literacy Level and Functional Outcomes in Patients With Hand and Forearm Injuries

March 9, 2026 updated by: HANDE USTA, Pamukkale University

Examining the Relationship Between Health Literacy Level and Functional Outcomes in Patients With Hand and Forearm Injuries

The aim of this study is to examine the association between health literacy, patient-reported outcome measures, and grip strength in a cohort of patients with hand injuries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: HANDE USTA OZDEMIR, PhD
  • Phone Number: +902582965845
  • Email: husta@pau.edu.tr

Study Locations

  • Turkey (Türkiye)
      • Denizli, Turkey (Türkiye)
        • Recruiting
        • Pamukkale University
        • Contact:
      • Denizli, Turkey (Türkiye), 20070
        • Not yet recruiting
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who were referred to the hand rehabilitation unit for hand or forearm injuries, aged 18-65 years who voluntarily agreed to participate will be included to the study

Description

Inclusion Criteria:

  • Aged 18-65 years
  • Voluntarily agreed to participate
  • Presented with hand and/or forearm injuries

Exclusion Criteria:

  • Concomitant shoulder or elbow injuries
  • History of surgery due to neurological, rheumatological, or metabolic conditions affecting the entire upper extremity
  • Employment in a health-related profession

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with hand and/or forearm injuries
Patients aged 18-65 years who voluntarily agreed to participate and who presented with hand and/or forearm injuries
Other: Patients who were referred to the hand rehabilitation unit for hand or forearm injuries will be followed for 12 weeks
Conventional hand therapy will be applied (edema and scar management, exercises) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
European Health Literacy Scale
Time Frame: post-injury 12th week.
The scale is based on a conceptual framework comprising three health-related domains (treatment, disease prevention, and health promotion) as well as four information-processing stages (accessing, understanding, appraising/decision-making, and applying health information). The instrument contains 47 items rated on a four-point Likert scale.The total score is standardized to range from 0 to 50. Health literacy levels are categorized as follows: (0-25): insufficient, (>25-33): problematic-limited, (>33-42): sufficient, (>42-50): excellent
post-injury 12th week.
Michigan Hand Outcomes Questionnaire
Time Frame: post-injury 12th week
The MHOQ assesses hand and wrist status across six domains: function, activities of daily living, work performance, pain, aesthetics, and patient satisfaction. It consists of 63 items addressing both hands. Each item is scored on a 1-5 scale, and each domain score is converted to a 0-100 scale. Except for the pain domain, higher scores indicate better outcomes
post-injury 12th week
Grip strength
Time Frame: post-injury 12th week
Grip strength was assessed according to the procedure recommended by the American Society of Hand Therapists. A Jamar dynamometer was used to evaluate gross grip strength. Measurements were performed with the patient seated without elbow support, the arm in adduction and neutral rotation, the elbow flexed at 90°, the forearm in a neutral position, and the wrist positioned in approximately 30° extension. Beginning with the dominant hand, measurements were taken on both sides. The mean value of three trials was recorded
post-injury 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-60116787-020-789611

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We may share de-identified IPD upon reasonable request and subject to appropriate data-use agreements, provided that sharing aligns with participant consent and institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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