Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing Municipality, 100176, China
Completed
NCT Number: NCT05716308
The Effect Evaluation of Continuous Nursing Intervention in Patients With Type 2 Diabetic Retinopathy
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.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
A continuous nursing intervention group was established.
BehavioralIntervention 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
Primary outcomes
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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
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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.
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Criteria for visual acuity changes
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Beijing Tongren Hospital
Other
Registry information
Important dates
- Study start
- 2019
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Feb 8, 2023
- Registry last updated
- Feb 8, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.