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Sustainable and Active Program-Development and Application of SAVING Methodology.

ABSTRACT: The SAVING project aimed to create a sustainable and active aging program to promote the transition to sustainable aging in residential structures for the elderly (RSEs), developing research activities to apply the best strategies and good practices regarding the promotion of an active, healthy, and sustainable aging regarding social, economic, environmental, and pedagogic aspects. All this innovative methodology was built on a living-lab approach applied in one RSE, that was used as a case study. The results showed that the creation of the SAVING Brigade allowed not only increased reflection and mutual learning, but also created better conditions to face uncertainties and obstacles. Moreover, the use of indicators supported the basic themes and enabled comparison with other studies, between institutions or programs. Finally, the Action Plan acted as a tool for the development of previously defined strategies. It is possible to conclude that the breadth of the concept of quality of life encompasses the physical health of the individual, their psychological state, their social relationships, their perceptions, and the relationship with the characteristics of the context in which they are inserted. Therefore, active, sustainable, and healthy aging should be the goal.

SUBMITTER: Almeida-Silva M

PROVIDER: S-EPMC9180391 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Sustainable and Active Program-Development and Application of SAVING Methodology.

Almeida-Silva Marina M Monteiro Ana A Carvalho Ana Rita AR Teixeira Ana Marta AM Moreira Jéssica J Tavares David D Tomás Maria Teresa MT Coelho Andreia A Manteigas Vítor V

International journal of environmental research and public health 20220602 11

The SAVING project aimed to create a sustainable and active aging program to promote the transition to sustainable aging in residential structures for the elderly (RSEs), developing research activities to apply the best strategies and good practices regarding the promotion of an active, healthy, and sustainable aging regarding social, economic, environmental, and pedagogic aspects. All this innovative methodology was built on a living-lab approach applied in one RSE, that was used as a case stud ...[more]

PMID: 35682385

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Project description:BackgroundThe design of clinical trials in rare diseases is often complicated by a lack of real-world translational knowledge. Fibrodysplasia ossificans progressiva (FOP) is an ultra-rare genetic disorder characterized by skeletal malformations and progressive heterotopic ossification (HO). Palovarotene is a selective retinoic acid receptor gamma agonist. Here, we describe the methodology of three studies in the palovarotene clinical development program in FOP and discuss insights that could inform future research, including endpoint suitability and the impact of trial design.MethodsPVO-1A-001 (NCT02322255) was a prospective, protocol-specified, longitudinal FOP natural history study (NHS). PVO-1A-201 (NCT02190747) was a randomized, double-blind, placebo-controlled phase II trial; PVO-1A-202 (NCT02279095) was its open-label extension. Trial designs, including treatment regimens and imaging assessments, were refined between PVO-1A-201 and PVO-‍1A-202, and within PVO-1A-202, based on emerging data as the studies progressed. Palovarotene doses were administered using a flare-up treatment regimen (higher dose for 2/4 weeks, followed by lower dose for 4/≥8 weeks; from flare-up onset), with or without accompanying chronic (daily) treatment. Flare-up and disease progression outcomes were assessed, including incidence and volume of new HO during flare-ups and/or annually, as well as other clinical, patient-reported, and exploratory outcomes. Safety was monitored throughout all studies.ResultsOverall, 114 and 58 individuals with FOP were enrolled in the NHS and phase II trials, respectively. Results of the NHS and PVO-1A-201 were published in 2022; complete results of PVO-1A-202 will be publicly available in due course. Together the studies yielded important information on endpoint suitability, including that low-dose whole-body computed tomography was the optimum imaging modality for assessing HO progression annually and that long study durations are needed to detect substantial changes in functional and patient-reported outcomes.ConclusionsA flexible clinical development program is necessary for underexplored rare diseases to overcome the many challenges faced. Here, the NHS provided a longitudinal evaluation of FOP progression and interventional trials were based on emerging data. The studies described informed the design and endpoints implemented in the phase III MOVE trial (NCT03312634) and provide a foundation for future clinical trial development.Trial registrationNCT02322255 (registered 23/12/2014); NCT02190747 (registered 15/07/2014); NCT02279095 (registered 30/10/2014).

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Sustainable and Active Program-Development and Application of SAVING Methodology.

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Sustainable and Active Program-Development and Application of SAVING Methodology.

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