RESUMO
BACKGROUND: POSITIVE (i.e. maintaining and imPrOving the intrinSIc capaciTy Involving primary care and caregiVErs) is a new intervention program consisting of home-monitoring equipment and a communication platform to support treatment of frailty symptoms initially in primary care and prevent disability in older adults. METHODS: The primary objectives are to estimate the potential efficacy of the POSITIVE system on improving frailty in at least one point in Fried's criteria and five points in Frailty Trait Scale. The secondary objectives are to (A) assess the recruitment, retention, drop-out rates, compliance with the intervention and the intervention mechanisms of impact; (B) evaluate the usability and acceptance of the POSITIVE system, and to get estimations on; (C) the potential efficacy of the intervention on improving the participants' physical performance, cognitive functions, mood, independency level in activities in daily living, the impact on quality of life and number of falls during the follow-up period; (D) the impact on the caregiver quality of life and caregiver burden; and (E) on the consumption of health care resources, participants' perception of health and level of care received, and healthcare professionals' workload and satisfaction. A randomised controlled, assessor-blinded pilot study design recruiting from a primary care centre in Stockholm Region will be conducted. Fifty older adults identified as pre-frail or frail will be randomised into a control or an intervention group. Both groups will receive a medical review, nutritional recommendations and Vivifrail physical exercise program. The intervention group will receive the POSITIVE-system including a tablet, the POSITIVE application and portable measurement devices. The participants receiving the POSITIVE program will be monitored remotely by a primary care nurse during a 6-month follow-up. Data will be collected at baseline, 3 and 6 months into the intervention though the platform, standardised assessments and surveys. A process evaluation as per Medical Research Council guidance will be conducted after the 6-month follow-up period. DISCUSSION: The implications of the study are to provide estimations on the potential efficacy of the POSITIVE system in improving frailty among older adults and to provide relevant data to inform powered studies of potential efficacy and effectiveness, as well as to inform about the feasibility of the current study design. TRIAL REGISTRATION: ClinicalTrials.gov. REGISTRATION NUMBER: NCT04592146 . October 19, 2020.
