Tackling frailty at primary care: evaluation of the effectiveness of a multicomponent intervention through a randomised controlled trial: study protocol

• Main Authors: Francisco Rivas-Ruiz, Mónica Machón, Maider Mateo-Abad, Eugenio Contreras-Fernández, Carolina Güell, Luis Baro-Rodríguez, Kalliopi Vrotsou, Raúl Quirós-López, Itziar Vergara, Itziar Vergara Mitxeltorena, Mónica Machón Sobrado, Maider Mateo Abad, Miren Revuelta Aramberri, Carolina Güell Pelayo, Ana Isabel Diez Ruiz, Irati Rodríguez Matesanz, Iván Antón Rodrigo, Ana Isabel Calderón Durán, Jimena Abiles Osinaga, María Padilla Ruiz, María Dolores Llamas del Castillo, Felipe Salas Samper, María Antonia Nava del Val, Susana Clavero Cano, Sonia María Lozano Gómez, Isabel María Rodríguez Jiménez, Beatriz León Salas
• Format: Article
• Language: English
• Published: BMJ Publishing Group 2020-02-01
• Series: BMJ Open
• Online Access: https://bmjopen.bmj.com/content/10/2/e034591.full

IntroductionThis project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty. The final evaluation will be made at 12 months’ follow-up.Methods and analysisPragmatic multicentre cluster randomised controlled clinical trial, single blind with two arms: multifactorial intervention in PHC versus usual follow-up. The randomisation unit is the patient list and the analysis unit is the patient. In addition, a cost-effectiveness study and a qualitative study will be carried out, the latter based on semistructured interviews and focus groups. Two hundred persons (100 per study branch) all aged ≥70 years, presenting frailty, but functionally independent and resident in the community, will be recruited. A baseline evaluation will be carried out prior to the intervention, with follow-up at 6 and 12 months. The main study variables considered will be functional capacity and incidence of adverse events; the secondary variables considered will be the patients’ sociodemographic characteristics, nutritional status, level of physical activity and drug consumption, together with data on comorbidity, cognitive and affective status and health-related quality of life. Data will be analysed according to the intention-to-treat principle using a 5% significance level.Ethics and disseminationThe study will at all times be conducted in strict accordance with the provisions of the Declaration of Helsinki and with the national legislation regulating patients’ autonomy. All patients recruited will be asked to provide written informed consent before taking part in the clinical trial. On completion of the study, the principal investigator expects to publish the results of this research in a peer-reviewed open access scientific journal.Trial registration numberISRCTN17143761.