Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates (ADHERE)
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
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Anna Tan CS Clinical Associate Professor, PhD
- Puhelinnumero: +65-63227424
- Sähköposti: anna.tan.c.s@singhealth.com.sg
Tutki yhteystietojen varmuuskopiointi
- Nimi: NEO WT Clinical Research Coordinator, Diploma
- Puhelinnumero: +65-90584081
- Sähköposti: neo.wee.teck@seri.com.sg
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who are unwilling or unable to perform CAT testing.
- Unable to provide informed consent.
- Significant eye pathology such as cornea problems, glaucoma, or other retinal diseases that may substantially affect vision.
- Do not speak English or Mandarin fluently.
- Cognitive impairment (as assessed using 6CIT).
- Obvious observable physical or hearing disabilities that prevents them from completing the CAT questionnaire and undergoing MPI effectively.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Multidisciplinary protocolized intervention (MPI)
Consists of medical consultation, to optimize the treatment regimen, and combinations of appropriate referrals to either (1) a nurse-directed patient education program (NE), (2) a low vision optometrist (OP), (3) an occupational therapy services (OT) and/or (4) a medical social worker (SW). CATs specific to AMD and DME will be used to measure QoL by collecting scores in various patient-informed domains. Lower scores at baseline, or a significant reduction in scores on follow-up visits in the various domains, will inform potential areas to address and tailor our MPI accordingly. |
Our novel proposed approach to improve adherence to IVT is personalized patient-centred care comprising a multidisciplinary protocolized intervention (MPI), which consists of medical consultation, to optimize the treatment regimen, and combinations of appropriate referrals to either (1) a nurse-directed patient education program (NE), (2) a low vision optometrist (OP), (3) an occupational therapy services (OT) and/or (4) a medical social worker (SW).
|
|
Placebo Comparator: Standard care
In the standard care arm, the treating clinician will be masked from the CAT scores and will use his/her own discretion when recommending the treatment regimen or when making any appropriate nurse or allied health referrals, independent of the CAT scores.
|
The CAT scores will be recorded by the clinical research coordinator at baseline and follow-up visits for comparison to the MPI arm.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Effectiveness of multidisciplinary protocolized intervention (MPI) in improving adherence to intravitreal (IVT) Injection.
Aikaikkuna: From 6 month to 18 months.
|
Adherence is defined as
|
From 6 month to 18 months.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Comparison of CAT scores (Specific aim 2A) from the CAT questionnaire database
Aikaikkuna: Baseline, 6,12 and 18 month
|
CAT scores will be collected via a hybrid remote or in-clinic delivery method. At baseline, CATs will be administered in-clinic or via CAT links sent by WhatsApp to their contact number . At subsequent timepoints, relevant CAT links will be sent via a WhatsApp message to their designated contact number, to complete the questionnaire remotely on their own SMART device, before their appointment. Those who are unable to complete CAT testing remotely will be given an additional opportunity to complete them in-clinic using an internet enabled tablet in person at their clinic visit with/without CRC assistance. The CAT scores will be assessed by clinical research coordinator. |
Baseline, 6,12 and 18 month
|
|
Effectiveness of MPI in improvement of visual function
Aikaikkuna: Enrolment to 18 months
|
Visual function -Monocular and binocular presenting corrected VA and CS (Specific aim 2B) will be collected from the clinical records.
If data are not present, the CRCs will conduct these tests on participants using standardized protocols.domain-specific
CAT scores at each follow-up time point.
Compared to those in standard care, patients in the MPI group will have improved VA and CS at each follow-up time point.
|
Enrolment to 18 months
|
|
Effectiveness of MPI in increasing disease-free intervals in patients with nAMD or DME receiving IVT and having suboptimal CAT scores.
Aikaikkuna: At the end of 18-month time point.
|
Disease free intervals as defined by the maximum IVT treatment interval where no disease activity recurrence is detected on OCT will be collected from clinical records and OCT images from the clinical database (Specific aim 2B).
|
At the end of 18-month time point.
|
|
The implementation outcomes of MPI through mixed method testing with interviews and questionnaires (Specific aim 3).
Aikaikkuna: 6 to 15 months.
|
The PI, assisted by their Co-Is and collaborators, will identify eligible individuals for qualitative interviewing that will be performed with major stakeholders between 6 to 15 months timeline. These include the clinicians, nurses and the allied health specialists (OP, OT and SW) who will be involved in administering the MPI, and patients and care-givers who receive the MPI. Potential individuals will be contacted over email or phone call, and a trained study team will follow up on affirmative responses by obtaining written informed consent to carry out the following study procedures. Semi-structured (1-on-1) interviews with the above key stakeholders will be conducted to explore their perspectives on barriers and enablers of integrating MPI into a Singapore public hospital for the management of nAMD and DME patients receiving IVT. Purposive and snowball sampling will be used to ensure all stakeholder groups are represented. Interviews will be conducted until no new data emerges. |
6 to 15 months.
|
|
To assess the cost-effectiveness of the MPI for improving adherence to IVT, considering its potential impact on long term visual acuity (VA) loss and QoL adjusted years (QALYs).
Aikaikkuna: Baseline and 18-month
|
The sample size required for cost-effectiveness analysis is usually larger than clinical studies as it involves estimating the joint distribution of patient outcomes and costs.
Furthermore, power calculations require setting a willingness-to-pay threshold, which is not known for Singapore.
However, as cost-effectiveness is more concerned with estimating effect size rather than hypothesis testing, it can still provide valuable information even if underpowered.
Instead of confidence intervals, sensitivity analysis will be used to assess the range of estimated values.
|
Baseline and 18-month
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Anna CS Tan, PhD, Singapore Eye Research Institute (SERI)
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- MOH-001922-00
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .