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The Effect Evaluation of Continuous Nursing Intervention in Patients With Type 2 Diabetic Retinopathy

Primary Purpose

Type 2 Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
A continuous nursing intervention group was established.
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetic Retinopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: (1) DR diagnosis and classification criteria in line with the latest version of the 2017 Clinical Guidelines for Diabetic Retinopathy developed by the American Eye Association [9]; (2) Type 2 diabetes course of more than 5 years, with varying degrees of retinopathy; (3) Monocular disease, no blindness; (4) Education level above primary school; - (5) Patients informed consent for this study and signed a consent form. Exclusion Criteria: (1) with severe cerebral hemorrhage or cerebral infarction, severe nephrotic syndrome, senile dementia, cardiovascular and cerebrovascular diseases; (2) Patients with macular edema, severe corneal (and) or lens opacity affect the observation of the fundus, angle-closure glaucoma can not mydriasis, other fundus diseases, and nursing interventions for other chronic diseases. This study was approved by the ethics committee of our hospital.

Sites / Locations

  • Beijing Tongren Hospital,Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

Continuous nursing intervention was performed on the basis of the control group

discharge guidance was performed according to routine nursing intervention at the time of discharge, and the patients were informed to return to the hospital for regular review (review was performed at 1 month, 3 months, half a year, 1 year, and 2 years after discharge, respectively).

Outcomes

Primary Outcome Measures

DR patient care satisfaction questionnaire during follow-up
Each item was scored according to three levels of 10 points, 6 points and 2 points, with a total score of 20-100 points. The higher the score, the higher the nursing satisfaction
The Summary of Diabetes Self-Care Activities (SDSCA)
The translated Chinese version of the SDSCA scale consists of 11 items, reflecting five parts of self-management : diet, exercise, blood glucose monitoring, foot care, and drugs. Each item is scored by 8 levels of 0-7 points, of which 1 item is a reverse question. The purpose of this scale is to measure the self-management behavior of patients within 7 days. The total score is 0~77 points. The higher the score, the better the self-management ability. Above 56 points is good for self-management ability, 42~56 points is medium, and below 42 points is poor.
Criteria for visual acuity changes
Significant improvement: visual acuity improvement≥4 lines. improvement: vision improvement≥2 lines. unchanged: visual acuity increased by 1 line or decreased by 1 line. decline: visual decline≥2 lines.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2023
Last Updated
January 28, 2023
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05716308
Brief Title
The Effect Evaluation of Continuous Nursing Intervention in Patients With Type 2 Diabetic Retinopathy
Official Title
The Effect Evaluation of Continuous Nursing Intervention in Patients With Type 2 Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

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

5. Study Description

Brief Summary
Objective: To evaluate the application effect of continuous nursing intervention in type 2 diabetic retinopathy (DR), and to explore its clinical application value. Methods:Patients with type 2 DR admitted to our Hospital from June 2019 to June 2022 were selected as the research objects and divided into intervention group and control group by random number table method. The control group received routine nursing intervention, and the intervention group received continuous nursing intervention on the basis of the control group. The related effect evaluation indexes such as fasting blood glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin and visual acuity were collected and compared between the two groups at discharge, 1 year and 2 years after discharge. The readmission rate of the two groups was counted to evaluate the effect of continuous nursing intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetic Retinopathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Continuous nursing intervention was performed on the basis of the control group
Arm Title
control group
Arm Type
No Intervention
Arm Description
discharge guidance was performed according to routine nursing intervention at the time of discharge, and the patients were informed to return to the hospital for regular review (review was performed at 1 month, 3 months, half a year, 1 year, and 2 years after discharge, respectively).
Intervention Type
Behavioral
Intervention Name(s)
A continuous nursing intervention group was established.
Other Intervention Name(s)
The establishment of patient records, patients admitted to hospital by the primary nurse to record the basic situation of patients, Personalized nursing intervention was given during hospitalization, After discharge to give continuous care, organize patients to join the WeChat group, group to share knowledge of DR-related diseases
Intervention Description
Intervention group: Continuous nursing intervention was performed on the basis of the control group: ①A continuous nursing intervention group was established. The group members included chief physician, attending physician, head nurse, specialist nurse and nutritionist. ②The establishment of patient records, patients admitted to hospital by the primary nurse to record the basic situation of patients, including name, age, history of diabetes, DR staging, vision and blood glucose before treatment and other information. ③Personalized nursing intervention was given during hospitalization. Systematic health education was carried out for patients on admission. Targeted psychological counseling was given to some patients. ④After discharge to give continuous care, organize patients to join the WeChat group, group to share knowledge of DR-related diseases, to understand the patient 's medication, diet, vision, the patient 's questions and problems to guide and improve.
Primary Outcome Measure Information:
Title
DR patient care satisfaction questionnaire during follow-up
Description
Each item was scored according to three levels of 10 points, 6 points and 2 points, with a total score of 20-100 points. The higher the score, the higher the nursing satisfaction
Time Frame
2 years
Title
The Summary of Diabetes Self-Care Activities (SDSCA)
Description
The translated Chinese version of the SDSCA scale consists of 11 items, reflecting five parts of self-management : diet, exercise, blood glucose monitoring, foot care, and drugs. Each item is scored by 8 levels of 0-7 points, of which 1 item is a reverse question. The purpose of this scale is to measure the self-management behavior of patients within 7 days. The total score is 0~77 points. The higher the score, the better the self-management ability. Above 56 points is good for self-management ability, 42~56 points is medium, and below 42 points is poor.
Time Frame
2 years
Title
Criteria for visual acuity changes
Description
Significant improvement: visual acuity improvement≥4 lines. improvement: vision improvement≥2 lines. unchanged: visual acuity increased by 1 line or decreased by 1 line. decline: visual decline≥2 lines.
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (1) DR diagnosis and classification criteria in line with the latest version of the 2017 Clinical Guidelines for Diabetic Retinopathy developed by the American Eye Association [9]; (2) Type 2 diabetes course of more than 5 years, with varying degrees of retinopathy; (3) Monocular disease, no blindness; (4) Education level above primary school; - (5) Patients informed consent for this study and signed a consent form. Exclusion Criteria: (1) with severe cerebral hemorrhage or cerebral infarction, severe nephrotic syndrome, senile dementia, cardiovascular and cerebrovascular diseases; (2) Patients with macular edema, severe corneal (and) or lens opacity affect the observation of the fundus, angle-closure glaucoma can not mydriasis, other fundus diseases, and nursing interventions for other chronic diseases. This study was approved by the ethics committee of our hospital.
Facility Information:
Facility Name
Beijing Tongren Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100176
Country
China

12. IPD Sharing Statement

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The Effect Evaluation of Continuous Nursing Intervention in Patients With Type 2 Diabetic Retinopathy

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