Evaluation of the Effectiveness of a Community Health Management Program for Dry Eye Disease in Middle-Aged and Elderly Individuals

May 30, 2024 updated by: Zhang Shiyan, Fujian University of Traditional Chinese Medicine
This study evaluates the effectiveness of a community health management program for middle-aged and elderly patients with dry eye disease (DED). By comparing the community-based health management plan with conventional treatment, the study aims to determine the impact on eye health and quality of life.

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.
Interventional

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.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • The Third People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
        • Contact:

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

Description

Inclusion Criteria:

  1. Patients meeting the diagnostic criteria for dry eye disease.
  2. Middle-aged and elderly individuals aged 45 years and above.
  3. Normal cognitive and expressive abilities.
  4. Informed consent and ability to complete the survey.
  5. Voluntary participation in the study.

Exclusion Criteria:

  1. Patients with other ocular surface diseases, including stye, trachoma, allergic conjunctivitis, etc.
  2. Patients with severe cataracts, glaucoma, uveitis, retinal detachment, optic nerve diseases, high myopia, or other conditions.
  3. Patients who have undergone eye surgery or have a history of eye trauma in the past three months.
  4. Patients who did not sign the informed consent form.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Intervention group
Procedure: Health Management Intervention Program
This study implemented a 12-week eye health management intervention program based on the Protection Motivation Theory (PMT). The intervention included eye health interventions conducted twice weekly at community health service locations.During the health management process, specialist doctors from higher-level comprehensive hospitals provided professional guidance, while community general practitioners took on a leading role. They provided personalized eye health management for patients under the guidance of the PMT theory. The intervention content included group education, individual guidance, experience sharing meetings, and traditional Chinese medicine appropriate technology, among other aspects.
Placebo Comparator: Control group
Procedure: Standard Treatment
Each week, patients were subjected to standard treatment and follow-up procedures, including basic interventions, medication, and routine follow-up via phone or WeChat, during which general conditions were assessed.

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
Goal Attainment Scaling (GAS)
Time Frame: 12 weeks
GAS is an individualized assessment method encompassing multiple personal goals, with a standardized formula for calculating total scores to facilitate comparisons. A score of 50 represents the expected level of achievement, with higher scores indicating greater goal attainment. GAS demonstrates good reliability, validity, and sensitivity. Based on the GAS goal list, researchers and participants collaboratively select goals and assign weights. Expected goals (assigned 0 points) and other goal levels (significantly above expected +2, slightly above expected +1, slightly below expected -1, significantly below expected -2) are established. Goal attainment is evaluated during follow-up, and GAS scores are calculated.
12 weeks
Ocular Surface Disease Index (OSDI)
Time Frame: 12 weeks
The OSDI questionnaire assesses common dry eye symptoms and their frequency, aiding in the grading of dry eye severity. It focuses on symptoms such as dryness, foreign body sensation, stinging, photophobia, blurred vision, and the impact on daily life and environmental factors. Symptoms are rated on a scale of frequency: always (4 points), most of the time (3 points), half of the time (2 points), occasionally (1 point), and never (0 points). The OSDI total score is calculated as (sum of item scores × 25)/12, ranging from 0 to 100, with higher scores indicating more severe symptoms.
12 weeks
Schirmer I Test
Time Frame: 12 weeks
The Schirmer I test measures tear secretion by placing a Schirmer strip under the lower eyelid conjunctiva with the patient's eyes closed, measuring tear absorption over 5 minutes. This test is widely used to evaluate dry eye syndrome. Tear secretion measured by Schirmer I test (without anesthesia) >5 mm/5 min and ≤10 mm/5 min indicates mild dry eye; >3 mm/5 min and ≤5 mm/5 min indicates moderate dry eye; and ≤3 mm/5 min indicates severe dry eye.
12 weeks
Quality of Life for Dry Eye Patients
Time Frame: 12 weeks

NEI-VFQ-25：This is one of the most commonly used ophthalmic quality of life questionnaires, assessing vision-related issues and patients' quality of life. It consists of 25 questions divided into three parts: general health and vision, limitations in activities, and responses to vision problems. The items are categorized into dimensions such as overall health, overall vision, eye pain, near activities, distance activities, peripheral vision, color vision, driving, social functioning, role limitations, dependency, and mental health. Respondents rate their subjective experience on a 5 or 6-point scale, with scores weighted according to the question type, using values such as 100, 75, 50, 25, 0, or not scored. The highest possible score is 100, and the lowest is 0. Scores for each dimension are averaged, and overall scores for each section are averaged from the dimension scores. Higher scores indicate better quality of life.

8.Diagnostic Criteria for Dry eye disease (DED).
12 weeks

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.
Fujian University of Traditional Chinese Medicine

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.
February 1, 2024

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.
January 1, 2025

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.
January 1, 2025

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).
May 30, 2024

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.
May 30, 2024

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.
June 5, 2024

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.
June 5, 2024

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.
May 30, 2024

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.
May 1, 2024

More Information

Terms related to this study

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.
  • 2023ks-61-1

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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