NCT07567898Toborzás még nem indult
Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates
The Effectiveness of Multidisciplinary Protocolised Interventions to Reduce Non-adherencE Rates (ADHERE) in Patients With Chronic Macula Diseases Receiving Intravitreal Injections: A Randomised Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 5.
Rövid összefoglaló (regiszter, angolul)
The purpose of this research study is to test whether a personalised care approach improves adherence compared to standard care. Many patients with macular diseases like age-related macular degeneration and diabetic macular edema need regular eye injections to protect their vision. However, some do not adhere to their treatment appointments, risking further vision loss. You were selected as a possible participant in this research study because you have been diagnosed with neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) requiring intravitreal injection treatment (IVT). This research study targets to recruit 200 participants from the Singapore National Eye Centre. This study comprises two cohort groups: Cohort 1(Suboptimal CAT scores/ Randomized Control trial) and Cohort 2 (Optimal CAT scores/Observation). If you agree to take part in this study, the research coordinator will obtain your written consent before proceeding with the study procedures. You will be required to complete CAT assessment (via remote or administered in clinic) and assigned to cohort 1 or cohort 2 based on CAT scores result. If you are assigned to cohort 1, you will be randomly allocated to either the personalized multi-disciplinary protocolized intervention (MPI) or standard care group. Randomization means assigning you to one of two groups by chance, like tossing a coin or rolling a dice. * MPI group: You will complete a specialized computerized adaptive testing (CAT) quality of life questionnaire. Based on the domain specific scores, you will receive a medical consultation and a referral to nurse educators, optometrists, occupational therapists, or social workers. * Standard care group: If you are allocated to this group, you will receive standard care, where doctors make treatment decisions without using the CAT results. If you are assigned to cohort 2, you will be placed under prospective observation and undergo routine clinical care.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 200 (tervezett)
- Első benyújtás
- 2026. márc. 31.
- Kezdés
- 2026. ápr.
- Elsődleges befejezés
- 2027. márc.
- Fő szponzor
- Singapore Eye Research Institute
- NCT-szám
- NCT07567898
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 200
- 2026. ápr. és az elsődleges befejezés (2027. márc.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Significant eye pathology such as cornea problems, glaucoma, or other retinal diseases that may substantially affect vision.
- Cognitive impairment (as assessed using 6CIT).
Egyéb
- Patients who are unwilling or unable to perform CAT testing.
- Unable to provide informed consent.
- Do not speak English or Mandarin fluently.
- Obvious observable physical or hearing disabilities that prevents them from completing the CAT questionnaire and undergoing MPI effectively.
Kiket keres a vizsgálat
- Patients with chronic macula disease including those diagnosed with nAMD and DME, who require IVT.
- This would include treatment naive patients (no IVT in either eye the last 6 months) and previously treated patients who have had IVT in either eye in the last 6 months and require further IVT treatment at the baseline study visit in either eye.
- Able to provide informed consent and must consent to undergoing the MPI intervention.
- Speak English or Mandarin.
- Must be a Singapore resident.
Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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