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

January 28, 2023 updated by: Hui Du, Beijing Tongren Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • 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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100176
        • Beijing Tongren Hospital，Capital Medical 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

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intervention group
Continuous nursing intervention was performed on the basis of the control group
Behavioral: A continuous nursing intervention group was established.
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.
Other Names:
  • 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
NO_INTERVENTION: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DR patient care satisfaction questionnaire during follow-up
Time Frame: 2 years
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
2 years
The Summary of Diabetes Self-Care Activities (SDSCA)
Time Frame: 2 years
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.
2 years
Criteria for visual acuity changes
Time Frame: 2 years
  1. Significant improvement: visual acuity improvement≥4 lines.
  2. improvement: vision improvement≥2 lines.
  3. unchanged: visual acuity increased by 1 line or decreased by 1 line.
  4. decline: visual decline≥2 lines.
2 years

Collaborators and Investigators

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

Sponsor

Beijing Tongren Hospital

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)

June 1, 2019

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ACTUAL)

July 1, 2022

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 28, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 28, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingTH001

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.

Clinical Trials on Type 2 Diabetic Retinopathy

Clinical Trials on A continuous nursing intervention group was established.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe