Young Older Adults Clinical Trial
Official title:
The PreventIT Feasibility Randomised Controlled Trial in Young Older Adults, Comparing Two Lifestyle-integrated Exercise Interventions Delivered by Use of ICT or an Instructor, With a Control Group
The feasibility randomised controlled trial is part of the EU funded project "PreventIT" (2016-2018) responding to the Horizon 2020, Personalised health and care (PHC), call PHC-21: Advancing active and healthy ageing with ICT: Early risk detection and intervention. The PreventIT project focuses on a new behaviour change activity approach for young older adults (61-70 years of age) with an overall aim of early prevention of functional decline and to empower people to take care of their own health.
In this feasibility randomised controlled trial two interventions are compared with a control
group. The aLiFE programme includes instructor and paper manual delivery of life-style
integrated activities, while the eLiFE programme delivers the same activities by use of
smartphone and smartwatch applications. The control group is asked to follow the World Health
Organisation's physical activity recommendations.
The main aim is to assess feasibility of the aLiFE and eLiFE programmes and a second aim to
suggest sample size and design for a future Phase III clinical trial.
OBJECTIVES: How is the feasibility of having young older adults (between 61-70 years) to
perform the aLiFE and eLiFE interventions.
Specifically:
1. Participation: How is the adherence of specific activities and to the entire aLiFE and
eLiFE interventions of young older adults?
2. Technology: How is the feasibility and usability of the eLiFE intervention delivered
using smartphones and smartwatches as platform, regarding user interface, goal setting,
feedback, motivational messages, and social interaction?
3. Outcome measures: How is the risk reduction of functional decline, measured by the Later
Life Function and Disability Instrument and behavioural complexity, for the aLiFE and
the eLiFE interventions compared to a control group, and what are the estimates of
effect sizes for the primary and secondary study outcome measure?
4. Health economics evaluation: Is it feasible to collect data on, and estimate, health
care resource utilization, costs and quality-adjusted life years (QALYs), and model
incremental cost-effectiveness ratios (ICERs) of aLiFE, eLiFE compared with the control
group over a 6-month, 12-month, and 24-month time horizon?
The study is approved by the three ethical sites prior to study start.
(October 3rd, 2017) The final Data Analysis Plan has been closed before the start of the
first post-test assessment in the PreventIT feasibility RCT, starting on the 4th of October
2017.
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