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

Status

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

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 (Actual)

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.
100

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 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

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
  • 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

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
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

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
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

Sponsor

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

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.
June 1, 2019

Primary Completion (ACTUAL)

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.
June 1, 2022

Study Completion (ACTUAL)

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.
July 1, 2022

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).
January 19, 2023

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.
January 28, 2023

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.
February 8, 2023

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.
February 8, 2023

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.
January 28, 2023

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.
January 1, 2023

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.
  • 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.

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