Multidomain Intervention for the Reversal of Cognitive Frailty Using a Personalized Approach (AGELESS Trial): Recruitment and Baseline Characteristics of Participants

Ibrahim, A. M. and Singh, D. K. A. and Ludin, A. F. M. and Subramaniam, P. and Ai-Vyrn, C. and Ibrahim, N. and Haron, H. and Safien, A. M. and Khalid, N. M. and Ponvel, P. and Fadzil, N. H. M. and Hanipah, J. M. and Mangialasche, F. and Kivipelto, M. and Shahar, Suzana (2024) Multidomain Intervention for the Reversal of Cognitive Frailty Using a Personalized Approach (AGELESS Trial): Recruitment and Baseline Characteristics of Participants. JPAD-Journal of Prevention of Alzheimers Disease, 11 (5). pp. 1291-1306. ISSN 2274-5807, DOI https://doi.org/10.14283/jpad.2024.111.

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Official URL: https://doi.org/10.14283/jpad.2024.111

Abstract

BACKGROUND: Reversal of cognitive frailty through a multidomain intervention is desirable to prevent dementia. AGELESS Trial was conducted to determine the effectiveness of a comprehensive, multidomain intervention on older adults with cognitive frailty in Malaysia. However, conducting a clinical trial, particularly during and after Covid-19, posed unique challenges. OBJECTIVE: We aimed to investigate the recruitment process and baseline characteristics of the AGELESS Trial participants to better understand an at-risk population and those who agree to participate in an intervention. DESIGN/SETTING: 24-month, randomized controlled trial. PARTICIPANTS: Community-dwelling older adults with independent mobility, aged >= 60 years, with a mini mental state examination score of 19-25, a clinical dementia rating of 0.5 >= 1 Fried's physical frailty criteria, and < 22 Beck depression inventory. INTERVENTION: Participants were randomized 1:1 to a structured multidomain intervention consisting of vascular management, diet, exercise, cognitive and psychosocial stimulation, or to the arm, including routine care and general health consultation. MESAUREMENT: We analyzed the group differences between (1) cognitive frailty and non-cognitive frailty screened subjects, (2) recruited and non-recruited participants, (3) baseline characteristics of participants by arm, (4) adherence to AGELESS intervention at 12 months, and (5) preliminary findings on the effectiveness of the intervention at 12 months. RESULTS: A total of 957 older adults from two locations, i.e., urban (n = 764) and rural (n = 193) areas, were screened, of whom 38.9% had cognitive frailty and were eligible to participate. Those with cognitive frailty had fewer years of education (B = -0.08; 95%CI = 0.88-0.97; p = 0.002), and lower functioning cognition (B = -0.24; 95%CI = 0.74-0.84; p < 0.001). Among those from urban areas, only 33.1% (n = 106) agreed to participate, particularly those with multimorbidity (B = 0.86; 95%CI = 1.31-4.30; p = 0.01), higher physical activity (B = -1.02; 95%CI = 0.19-0.69; p = 0.002), slower walking speed (B = 1.26; 95%CI = 1.62-7.61; p = 0.001), and higher systolic blood pressure (B = 0.02; 95%CI = 1.00-1.03; p = 0.03). At baseline, participants' mean age was 68.1 +/- 5.6, years of education was 8.3 +/- 3.9, body mass index was 27.5 +/- 5.3 kg/m2, and mini mental state examination score was 22.7 +/- 4.0. Generally, there were no significant differences between the intervention and control groups for the main outcomes, except those in the intervention group had higher body mass index, mid-upper-arm circumference, and waist circumference (p < 0.05 for all parameters). Overall intervention adherence at 12 months was 52.8%, ranging from 52.8%-90.6% for each of the modules. Preliminary analysis of the effectiveness of the intervention at 12 months was positive on most of the cognitive domains, some of the nutrient intake and food groups, physical function, and vascular outcomes (p < 0.05 for all parameters). CONCLUSION: Despite the challenges posed by the pandemic, screening, recruitment, and 12-month intervention delivery were achieved in a Malaysian multidomain preventive randomized controlled trial in older adults at risk of dementia, with a satisfactory adherence rate and cognitive benefits at 12 months.

Item Type: Article
Funders: Faculty of Health Sciences, Universiti Kebangsaan Malaysia
Uncontrolled Keywords: AGELESS Trial; cognitive frailty; intervention; lifestyle; multi-domain; prevention; RCT
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Medicine
Universiti Malaya Medical Centre (UMMC)
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 16 Jan 2025 01:43
Last Modified: 16 Jan 2025 01:43
URI: http://eprints.um.edu.my/id/eprint/46887

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