The PreventIT Trial in Young Older Adults, Comparing Two Lifestyle-integrated Exercise Interventions
Condition: Young Older Adults
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): aLIFE; eLIFE; control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The aLiFE programme is taught by an instructor during six home visits and 3 phone calls during the 6-month intervention period. The programme will be personalised by use of an initial balance and strength assessment (aLiFE assessment tool). The participants assigns activities to his or her daily activities, and during subsequent home visits, the number of activities and task demands are upgraded. Participants will be taught how to select opportunities themselves to embed activities into their individual daily routine, and how to progress over time.; The eLIFE includes a personalised ICT-administered training schedule using the activities developed in aLiFE, delivered in the form of video clips, pictures and text/verbal instructions on a smartphone and smartwatch application. Personalisation of activity content will be decided based on a phenotype tool and initial difficulty level is decided through the aLiFE assessment tool. In addition, a virtual instructor teaches the participants how to carry out the eLiFE programme. The user receives motivational messages and feedback, and there will be a possibility for social interaction between the participants. The instructors teach the eLiFE participants the programme during 4 home visits and 3 phone calls during the 6 month intervention period.; The control group follows the World Health Organization's recommendations of physical activity. The control participants will receive one home visit and be given a written letter with the activity recommendations.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a feasibility study run as a randomised controlled trial (RCT). This is a multi-centre trial with three centres, Trondheim, Amsterdam, and Stuttgart, with two behaviour change exercise programmes (aLiFE and eLiFE) and a control group, with a 6 months intervention period and 6 month follow up.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Exercise; Feasibility Studies; Healthy Lifestyle; Health Promotion; Health Behavior; Aging; Activities of Daily Living; Mobile Applications