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

Sponsor
Beijing Tongren Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05716308
Collaborator
(none)
100
1
2
37
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: A continuous nursing intervention group was established.
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect Evaluation of Continuous Nursing Intervention in Patients With Type 2 Diabetic Retinopathy
Actual Study Start Date :
Jun 1, 2019
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jul 1, 2022

Arms and Interventions

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).

    Outcome Measures

    Primary Outcome Measures

    1. DR patient care satisfaction questionnaire during follow-up [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. The Summary of Diabetes Self-Care Activities (SDSCA) [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.

    3. Criteria for visual acuity changes [2 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tongren Hospital,Capital Medical University Beijing Beijing China 100176

    Sponsors and Collaborators

    • Beijing Tongren Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hui Du, doctor, Beijing Tongren Hospital
    ClinicalTrials.gov Identifier:
    NCT05716308
    Other Study ID Numbers:
    • BeijingTH001
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2023