A Trial on Ophthalmologist-delivered Health Education on Top of Routine Community Care
8 februari 2022 uppdaterad av: Zhongshan Ophthalmic Center, Sun Yat-sen University
The Effectiveness of Ophthalmologist-delivered Health Education on Top of Routine Community Care in Type 2 Diabetic Patients at Risk for Diabetic Retinopathy: A Parallel-group, Randomised Trial
Diabetic retinopathy affects over one third of all people with diabetes and is one of the leading causes of vision loss.
The management of diabetes and its complications should include screening for diabetic retinopathy.
A randomised trial is therefore needed of the use of a simple and widely practicable approach to explore the integration of eye care in managing diabetes.
The trial is designed as a randomised, controlled, superiority trial.
The aim is to explore the effectiveness of ophthalmologist-delivered health education on top of routine community care on blood glucose and eye-related clinical outcomes in type 2 diabetic patients at risk for diabetic retinopathy.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Diabetic retinopathy (DR) is a highly specific vascular complication of diabetes mellitus, with prevalence strongly related to a number of risk factors including the duration of diabetes, the level of glycaemic control, etc. Diabetic retinopathy affects over one third of all people with diabetes and is one of the leading causes of vision loss.
It is recommended that optimising glycaemic control could reduce the risk or slow the progression of diabetic retinopathy, and that the management of diabetes and its complications should include screening for diabetic retinopathy.
A randomised trial is therefore needed of the use of a simple and widely practicable approach to explore the integration of eye care in managing diabetes.
The trial is designed as a randomised, controlled, superiority trial.
The aim is to explore the effectiveness of ophthalmologist-delivered health education on top of routine community care on blood glucose and eye-related clinical outcomes in type 2 diabetic patients at risk for diabetic retinopathy.
Participants will be randomly assigned to either control or intervention group with a 1:1 allocation as per computer-generated random numbers.
A senior onsite manager will monitor participant enrolment over the course of the study.
An ophthalmologist-delivered health education will be offered as the intervention in an individualised, face-to-face counselling session to build awareness on diabetes symptoms, particularly on diabetic retinopathy, and its risk factors with appropriate management.
All subjects, regardless of the group allocation, will be followed up for 12 months.
Baseline and follow-up profiles will be assessed and collected by clinical personnel blind to group allocation.
The intervention arm will be compared against the control for all primary analysis.
The study was partly supported by the Open Research Funds of the State Key Laboratory of Ophthalmology.
Trial results will be disseminated to key stakeholders and the general medical community.
Studietyp
Interventionell
Inskrivning (Förväntat)
652
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Yuting LI, MPH
- Telefonnummer: +86-020-87334687
- E-post: liyuting@gzzoc.com
Studieorter
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510000
- Rekrytering
- Zhongshan Ophthalmic Center, Sun Yat-sen University
-
Kontakt:
- Yuting LI, MPH
- Telefonnummer: +86-020-87334687
- E-post: liyuting@gzzoc.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Age 35-80 years
- Clinically diagnosed with type 2 diabetes
- At risk of diabetic retinopathy (DR),e.g. no apparent DR or mild non-proliferative DR
- On regular community care by 'family doctor team' in the context of the National basic public health service delivery
Exclusion Criteria:
- With symptoms of cognitive dysfunction, dementia, severe mental disorders, or other conditions with inability to appropriately convey personal thoughts
- Type 1 diabetes or gestational diabetes
- Developed with eye conditions requiring timely treatment, e.g., diabetic macular edema, severe non-proliferative diabetic retinopathy, or proliferative DR
- Have a family member (including relatives) who participated in the trial with a different group assignment
- Currently enrol in other ongoing interventions that may exert additional effects on blood glucose control
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Insatsgrupp
|
The educational intervention will be conducted on-site by a qualified, experienced ophthalmologist at an ophthalmic center with goals of building awareness on diabetes symptoms, particularly on diabetic retinopathy, and its risk factors with appropriate management.
|
|
Övrig: Kontrollgrupp
|
Usual care follows standard procedure on diabetes management similar to the routine service provision.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Glycated haemoglobin (HbA1c)
Tidsram: 12-months follow-up
|
Proportion of participants who had optimal control of HbA1c level at 12 months
|
12-months follow-up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Treatment burden
Tidsram: 12-months follow-up
|
Use of treatment burden questionnaire to quantify item scores for each domain, in detail and together, on treatment burden of patients
|
12-months follow-up
|
|
Patients' adherence
Tidsram: 12-months follow-up
|
Use of adherence questionnaire to examine the extent to which physician advice, in detail and together, are adhered to by patients
|
12-months follow-up
|
|
Body mass index
Tidsram: 12-months follow-up
|
Use of weight and height to report body mass index in kg/m^2
|
12-months follow-up
|
|
Blood pressure
Tidsram: 12-months follow-up
|
Use of systolic and diastolic blood pressure to report blood pressure profile in mmHg
|
12-months follow-up
|
|
cholesterol concentration
Tidsram: 12-months follow-up
|
Use of cholesterol concentration to report lipid profile in mmol/L
|
12-months follow-up
|
|
triglyceride concentration
Tidsram: 12-months follow-up
|
Use of triglyceride concentration to report lipid profile in mmol/L
|
12-months follow-up
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 juli 2020
Primärt slutförande (Förväntat)
31 december 2024
Avslutad studie (Förväntat)
31 december 2024
Studieregistreringsdatum
Först inskickad
22 juli 2020
Först inskickad som uppfyllde QC-kriterierna
28 juli 2020
Första postat (Faktisk)
29 juli 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 februari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 februari 2022
Senast verifierad
1 februari 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SYSU-OPH-007
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .