Study of Effectiveness of Telemedicine in Identifying Diabetic Retinopathy Cases (DRTM)
21. april 2015 oppdatert av: Sanil Joseph, Aravind Eye Care System
Effectiveness of Tele-medicine in Identifying Diabetic Retinopathy Cases Attending Diabetologists' Clinics Compared to the Conventional Referral System
The aim of this study is to compare the effectiveness of identifying diabetic retinopathy using tele-medicine based Digital Retinal Imaging in Diabetes Clinics with that of the conventional referral system.
Hypothesis: Tele-medicine based digital retinal imaging involving a diabetes centre will identify proportionately more diabetic patients with DR and lead to higher acceptance rate with subsequent ophthalmic referral and management
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The design is a cluster randomized trial of tele-medicine versus usual care in diabetic patients.
The primary outcome of the study is the proportion of patients with confirmed DR at Aravind Eye Hospital (AEH).
DR will be graded using the International Clinical Diabetic Retinopathy Disease Severity Scale.
A sample size of 616 patients in both arms is required to detect a risk ratio of 1.8 or above at 90% power, 1% alpha and a design effect of 2. Eight clinics will be recruited and equally randomized to tele-medicine or usual care stratified by distance from AEH. Inclusion criteria include a confirmed diagnosis of diabetes, age over 50, no retinal exam in the previous year.
In the tele-medicine arm patients will be offered fundus imaging and patients diagnosed with DR or probable DR will be counselled to visit AEH to confirm DR.
In the usual care arm, the eligible patients will be counselled and referred to undergo an eye examination at AEH.
In both the arms the counselling and the awareness creation materials will be standardized.
Fundus imaging will be offered at the end of the study to those who refuse initially and all those in the usual arm who did not attend AEH.
Studietype
Intervensjonell
Registrering (Faktiske)
801
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Tamil Nadu
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Madurai, Tamil Nadu, India, 625020
- Aravind Eye Hospital
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Diabetic patients (as per ICD-9 code 250) in the age group of ≥50 years
Exclusion Criteria:
- Patients <50 years of age
- Already enrolled as study patients at the diabetes centre
- Patients screened for DR in free camps organized by the diabetes centre
- Diabetic patients who underwent retinal examination in the previous year prior to this intervention
- Patients with disability (physical or mental) who have difficulty in travelling to the eye hospital
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Tele-medicine
Tele-medicine aided retinal imaging and referral to eye hospital
|
Patients at the diabetes clinics will be subjected to non-mydriatic retinal imaging and the images will be transferred to the eye hospital via internet using a specified software - Aravind Diabetic Retinopathy Evaluation Software (ADRES) that enables a retinal specialist to read and grad the image and send the feedback immediately to the diabetes clinic.
Based on the presence or absence of DR the patients will be referred to the eye hospital for detailed retinal examination.
Andre navn:
|
|
Annen: Conventional Referral
Patients will be counselled on the importance of eye examination and will be referred to the eye hospital in the conventional manner.
|
All eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of patients with confirmed Diabetic Retinopathy (DR) diagnosed at the eye hospital
Tidsramme: 6 months
|
Out of the patients referred from the diabetes clinics to the eye hospital, the number of patients with confirmed DR will be measured.
This proportion will be compared between the two arms.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The severity of diabetic retinopathy (DR)
Tidsramme: 6 months
|
Among patients confirmed with DR, the severity of the disease will be measured using standard classification (Diabetic Retinopathy Disease Severity Scale) approved by the American Academy of Ophthalmology
|
6 months
|
|
The acceptance rate for referral in each arm
Tidsramme: 6 months
|
Out of the patients referred from the diabetes clinic, the number of patients actually reported to the eye hospital will be measured.
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6 months
|
|
Proportion of patients eligible for referral who had DR and who did not attend
Tidsramme: 6 months
|
Patients who are referred by not attended to the eye hospital will be followed up and examined to find out what proportion of them actually as DR
|
6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Barriers to compliance
Tidsramme: 6 months
|
Patients will be interviewed to identify the barriers to compliance following the referral
|
6 months
|
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Drivers of acceptance
Tidsramme: 6 months
|
Patients will be interviewed to identify the factors that encouraged them to visit the eye hospital following referral
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6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sanil Joseph, MHA, MSc, Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai, India
- Studiestol: Ramasamy Kim, DO, DNB, Aravind Eye Hospital, Madruai, India
- Studiestol: Thulasiraj Ravilla, MBA, Lions Aravind Institute of Community Ophthalmology, Aravind Eye Hospital, Madurai
- Studiestol: Astrid Fletcher, MSc, PhD, London School of Hygiene and Tropical Medicine
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2014
Primær fullføring (Faktiske)
1. januar 2015
Studiet fullført (Faktiske)
1. mars 2015
Datoer for studieregistrering
Først innsendt
5. februar 2014
Først innsendt som oppfylte QC-kriteriene
8. mars 2014
Først lagt ut (Anslag)
13. mars 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
22. april 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. april 2015
Sist bekreftet
1. april 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WT097685MA
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