Multidomain intervention for reversal of cognitive frailty, towards a personalised approach (AGELESS Trial): Recruitment and baseline characteristics of participants

Abstract

Abstract Introduction: Reversal of cognitive frailty through a multidomain intervention is desirable to prevent dementia. AGELESS Trial was conducted with the aim to determine the effectiveness of a comprehensive, multidomain intervention on older adults with cognitive frailty (CF). However, conducting a clinical trial particularly during or post the Covid-19 pandemic posed unique challenges. Therefore, this study focuses on describing the recruitment process and baseline characteristics of the participants and adherence at one year of the trial. Methods: Community dwelling older adults, aged 60 years old and above were screened for cognitive and physical impairment using Clinical Dementia Rating and FRIED criteria respectively. Parallel randomised controlled trial was conducted comparing multidomain module (five modules: vascular management, diet, physical exercise, cognitive and psychosocial) with usual care for 24 months. Results: A total of 957 older adults from two locations, ie. urban (n=764) and rural (n=193) areas were screened and 38.9% had CF and eligible to participate. Those with CF had lower years of education, and cognitive status as assessed using mini mental state examination (MMSE) (p<0.05 for both parameters). Among those from urban areas, only 13.87%(n=106) agreed to participate, particularly those with multimorbidity, with a higher physical activity level and walking speed (p<0.05 for all parameters). At baseline, mean age of participants was 68.1±5.6 years, education years was 8.3 ± 3.9 years, body mass index (BMI) was 27.0± 4.8 kg/m2 and MMSE was 22.7± 4.0. Generally, there were no significant difference between intervention and control groups for main outcomes, except those in intervention group had a higher BMI, mid upper arm circumference and waist circumference (p<0.05 for all parameters). Overall adherence towards intervention at one year was 52.8 %, ranging from 60% to 91% for each of the modules. In conclusion, only one third of those who were eligible from urban area for this trial agreed to participate, particularly among those with multimorbidity, higher physical activity level and walking. Understanding factors that influence recruitment and participation is crucial in personalising the trial to the targeted group and interpreting the data within the context of the study population.