Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners: a Randomised Controlled Trial

Author(s):  
BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024774 ◽  
Author(s):  
Diana Tang ◽  
Paul Mitchell ◽  
Victoria Flood ◽  
Annette Kifley ◽  
Alison Hayes ◽  
...  

IntroductionAge-related macular degeneration (AMD) is a leading cause of blindness. After smoking, nutrition is the key modifiable factor in reducing AMD incidence and progression, and no other preventative treatments are currently available. At present, there is an evidence–practice gap of dietary recommendations made by eye care practitioners and those actually practised by patients with AMD. To address this gap, a telephone-delivered dietary intervention tailored to patients with AMD will be piloted. The study aims to improve dietary intake and behaviours in patients with AMD. This type of nutrition-focused healthcare is currently not considered in the long-term management of AMD and represents the first empirical evaluation of a telephone-supported application encouraging adherence to dietary recommendations for AMD.Methods and analysis140 participants with AMD will be recruited for this randomised controlled trial. Those lacking English fluency; unwilling to engage in the intervention or provide informed consent were excluded. Following the completion of the baseline questionnaire, participants will be randomised into one of two arms: intervention or wait-list control (70 each in the intervention and control groups). Intervention participants will receive a detailed mail-delivered workbook containing information on healthy eating behaviours that promote optimal macular health, as well as scheduled phone calls over 4 months from an accredited practising dietitian. Descriptive statistics and multivariate stepwise linear regressions analyses will be used to summarise and determine the changes in dietary intakes, respectively. Economic analysis will be conducted to determine intervention feasibility and possibility of a large-scale rollout.Ethics and disseminationThe study was approved by the University of Sydney Human Research Ethics Committee (HREC) (Reference: HREC 2018/219). Study findings will be disseminated via presentations at national/international conferences and peer-reviewed journal articles.Trial registration numberACTRN12618000527268; Pre-results.


Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3083
Author(s):  
Diana Tang ◽  
Paul Mitchell ◽  
Gerald Liew ◽  
George Burlutsky ◽  
Victoria M. Flood ◽  
...  

There is an evidence–practice gap between the dietary recommendations for age-related macular degeneration (AMD) presented in the literature and those practiced by patients. This study reports on the 3-month post-intervention results of a randomised controlled trial (RCT) evaluating telephone-delivered counselling to improve dietary behaviours among AMD patients. A total of 155 AMD patients (57% female, aged 78 ± 8 years; control: 78, intervention: 77), primarily residing in New South Wales, Australia, were recruited. Participants completed a baseline questionnaire and a short dietary questionnaire (SDQ-AMD). The intervention included an evidence-based nutrition resource and four monthly calls with a dietitian. Immediately post-intervention, intervention participants repeated the SDQ-AMD and completed a feedback form. At 3 months post-intervention, both study arms repeated the SDQ-AMD. Statistical analyses included t-tests and McNemar’s test. Intervention participants reported satisfaction with the tailored phone calls, nutrition resource and nutrition education provided. At 3 months post-intervention, there was no statistically significant difference between study arms in the proportion of participants meeting the dietary goals nor in intake (mean servings ± SE) of total vegetables (primary outcome) and other key food groups; however, there was a significantly higher intake of nuts (secondary outcome) (3.96 ± 0.51 vs. 2.71 ± 0.32; p = 0.04) among participants in the intervention versus control group. Within the intervention arm, there were also significant improvements in intakes of the following secondary outcomes: dark green leafy vegetables (0.99 ± 0.17 vs. 1.71 ± 0.22; p = 0.003) and legumes (0.69 ± 0.10 vs. 1.12 ± 0.16; p = 0.02) and intake of sweets and processed/prepared foods (8.31 ± 0.76 vs. 6.54 ± 0.58, p = 0.01). In summary, although there were few dietary differences between study arms at 3 months post-intervention, the intervention involving four monthly calls was acceptable and helpful to the participants. This type of intervention therefore has the potential to provide people with AMD the needed support for improving their nutrition knowledge and dietary practices, especially if continued over a longer period.


BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e049411
Author(s):  
Annastazia E Learoyd ◽  
Adnan Tufail ◽  
Catey Bunce ◽  
Pearse A Keane ◽  
Ashleigh Kernohan ◽  
...  

ObjectiveManagement of age-related macular degeneration (AMD) places a high demand on already constrained hospital-based eye services. This study aims to assess the safety and quality of follow-up within the community led by suitably trained non-medical practitioners for the management of quiescent neovascular AMD (QnAMD).Methods/designThis is a prospective, multisite, randomised clinical trial. 742 participants with QnAMD will be recruited and randomised to either continue hospital-based secondary care or to receive follow-up within a community setting. Participants in both groups will be monitored for disease reactivation over the course of 12 months and referred for treatment as necessary. Outcomes measures will assess the non-inferiority of primary care follow-up accounting for accuracy of the identification of disease reactivation, patient loss to follow-up and accrued costs and the budget impact to the National Health Service.Ethics and disseminationResearch ethics approval was obtained from the London Bloomsbury Ethics Committee. The results of this study will be disseminated through academic peer-reviewed publications, conferences and collaborations with eye charities to insure the findings reach the appropriate patient populations.Trial registration numberNCT03893474.


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