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Comparative Study of Psychology and Glaucoma Knowledge in Glaucoma Day-ward Patients Inpatients

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
randomized to day ward
randomized to inpaitent
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Glaucoma focused on measuring knowledge, psychology

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is diagnosed with glaucoma;
  2. Will receive glaucoma surgery;
  3. Voluntary participation in this study;
  4. Have enough language comprehension ability;
  5. Best corrected visual acuity reach 0.1 or better;
  6. Patient or his legal representative has sign the informed consent.

Exclusion Criteria:

  1. Patient with mental disorder;
  2. There are important viscera function failure or other serious disease, including clinical related coronary artery disease, cardiovascular disease or myocardial infarction into the group of the first six months; serious neurological or psychiatric illness; serious infections; coagulant function abnormality; general active infectious diseases; malignant tumor; serious immune diseases;
  3. Patient with monocular blindness;
  4. Axial length≤20 mm;
  5. With other serious eye diseases;
  6. Neurologic diseases that could affect the visual field;
  7. 3 months prior to research to participate in any clinical study;
  8. Researchers think not suitable to participate in this clinical trial subjects;
  9. Refused to sign the informed consent.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-San Univerdity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

day-ward group

inpatient group

Arm Description

Outcomes

Primary Outcome Measures

Change of depression and anxiety score
The outcome will be measured by The Hospital Depression and Anxiety Scale (HADS). It consists of two subscales: HDAS-anxiety and HADS-depression. Each item is srored from 0-3, with higher scores indicating a higher level of depression and anxiety. For each of the seven-item subscales, the minimum sum score is 0, and the maximum is 21.
Change of glaucoma knowledge score
The outcome will be measured by The Gray Glaucoma Knowledge Questionaire. This quesionanire has a total maximum score of 17, with higher scores representing better knowledge.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2017
Last Updated
July 22, 2020
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03125850
Brief Title
Comparative Study of Psychology and Glaucoma Knowledge in Glaucoma Day-ward Patients Inpatients
Official Title
Comparative Study of Psychology and Glaucoma Knowledge in Glaucoma Day-ward Patients Inpatients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
December 10, 2017 (Actual)
Study Completion Date
January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the glaucoma day-ward patients' efficacy with inpatients by evaluating the glaucoma knowledge and psychology , and will analysis the reasons of the differences. Half of participants will receive treatment in day-ward, while the other half will receive treatment in hospital.
Detailed Description
Ophthalmic surgery has short operative time, quick recovery, and small anesthesia risk, making day case surgery the main management mode of ophthalmic surgery. This study will explore the differences of psychology and glaucoma knowledge between glaucoma day-ward patients and the inpatients. The data will be collected by scale on admission and discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
knowledge, psychology

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
day-ward group
Arm Type
Experimental
Arm Title
inpatient group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
randomized to day ward
Intervention Description
Participants will be randomized to day-ward group, and will accept routine treatment, care, centralized education of glaucoma knowledge
Intervention Type
Other
Intervention Name(s)
randomized to inpaitent
Intervention Description
Participants will be randomized to day-ward group, and will accept routine treatment, care, centralized education of glaucoma knowledge
Primary Outcome Measure Information:
Title
Change of depression and anxiety score
Description
The outcome will be measured by The Hospital Depression and Anxiety Scale (HADS). It consists of two subscales: HDAS-anxiety and HADS-depression. Each item is srored from 0-3, with higher scores indicating a higher level of depression and anxiety. For each of the seven-item subscales, the minimum sum score is 0, and the maximum is 21.
Time Frame
at baseline and 1 hour before discharge
Title
Change of glaucoma knowledge score
Description
The outcome will be measured by The Gray Glaucoma Knowledge Questionaire. This quesionanire has a total maximum score of 17, with higher scores representing better knowledge.
Time Frame
at baseline and 1 hour before discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is diagnosed with glaucoma; Will receive glaucoma surgery; Voluntary participation in this study; Have enough language comprehension ability; Best corrected visual acuity reach 0.1 or better; Patient or his legal representative has sign the informed consent. Exclusion Criteria: Patient with mental disorder; There are important viscera function failure or other serious disease, including clinical related coronary artery disease, cardiovascular disease or myocardial infarction into the group of the first six months; serious neurological or psychiatric illness; serious infections; coagulant function abnormality; general active infectious diseases; malignant tumor; serious immune diseases; Patient with monocular blindness; Axial length≤20 mm; With other serious eye diseases; Neurologic diseases that could affect the visual field; 3 months prior to research to participate in any clinical study; Researchers think not suitable to participate in this clinical trial subjects; Refused to sign the informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingkai Lin, MD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-San University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-San Univerdity
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No.

Learn more about this trial

Comparative Study of Psychology and Glaucoma Knowledge in Glaucoma Day-ward Patients Inpatients

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