Salutogenic Model-Based Frailty Prevention Program for Pre-Frail Women Aged 55 Years and Over (SAFRAPP): A Study Protocol for a Randomized Controlled Trial

Background: Frailty is a geriatric syndrome which is more higher among women. Limited evidence suggests a model-based intervention for preventing worsening frailty for women. Purpose: This protocol describes a single-blinded, two-armed randomized controlled study purposing to examine the effectiveness of Salutogenic Model-Based Frailty Prevention Program (SAFRAPP) for pre-frail women. Methods: Eighty-four eligible participants from vocational institutions of a municipality in Turkey is randomly allocated to either the SAFRAPP intervention or the control group. The SAFRAPP is a 6-week online nurse-led intervention program comprising of laughter yoga, health education and case management. The intervention is rooted in the Salutogenic Model, which focuses on strengthening individuals' coping capacity to deal with stressors. The primary outcomes are the frailty and sence of coherence scores and the secondary outcomes are the well-being, quality of life and fear of fall scores, and number of falls and emergency admissions in the past three months. The study data for intervention and control group is obtained at four times: At baseline and at the 3-month, 6-month and 9-month follow-ups. Results: The protocol was registered at ClinicalTrials.gov (identifier number NCT04787432, registration date: 08/03/2021). Eligibility, baseline measurements, randomization, and intervention are completed. The follow-ups are ongoing. Implications for Practice: There is unsufficient evidence regarding the effectiveness of a model-based health promotion interventions for prevention of frailty. The SAFRAPP will provide evidence on prevention of frailty and improving sense of coherence of pre-frail women.