The Effectiveness of a PRoactive Multicomponent Intervention Program on Disability in Independently Living Older People: A Randomized Controlled Trial.

BACKGROUND: There is an increase in functional limitations and a decline in physical and mental well-being with age. Very few effective lifestyle interventions are available to prevent adverse outcomes such as disability in (pre-) frail older people. The effectiveness of an interdisciplinary multicomponent intervention program to prevent disability in older people in the community was tested.
METHOD: A randomized controlled trial (RCT) with a one-year follow-up was conducted in the Netherlands. Community-dwelling pre-frail older people aged 65 years and over were invited to participate. Frailty was measured with the Groningen Frailty Indicator (GFI) and categorized into non-frail (GFI=0), pre-frail (GFI = 1-3) and frail (GFI ≥ 4). The intervention program consisted of four components: a medication review, physical fitness, social skills, and nutrition. OUTCOMES: The primary outcome was activity of daily living (ADL) measured with the Katz-6. Secondary outcomes were quality of life (SF-12) and healthcare consumption such as hospital admission, nursing home admission and primary care visits. Additional outcomes measured in the intervention group were physical fitness, Instrumental Activities of Daily Living (IADL), muscle strength, walking speed, functional capacity, mobility, feelings of depression and loneliness and nutritional status. The data were collected at baseline, after each intervention component and at a 12-month follow-up. An intention to treat analysis was used.
RESULTS: In total, there were 290 participants, and 217 (74.8%) completed the study. The mean age was 74 (SD: 7.2), most were pre-frail (59.9%), the majority were female (55.2%), and the individuals were not living alone (61.4%). After the 12-month follow-up, the median Katz-6 score did not change significantly between the two groups; adjusted Odds Ratio (OR) = 0.96 (95% Confidence Interval (CI): 0.39-2.35, p-value 0.92). No statistically significant differences were observed between the groups for quality of life and healthcare consumption. Among the participants in the intervention group, IADL (Friedman's test p <=0.04, X2 =6.50), walking speed (Friedman's test p <0.001, X2 =19.09) and functional capacity (Friedman's test p <0.001, X2 =33.29) improved significantly after the one-year follow-up. Right-hand grip strength improved immediately after completion of the intervention (Wilcoxon signed-rank test p=0.00, z= -3.39) but not after the 12-month follow-up.
CONCLUSION: The intervention program did not significantly improve daily functioning, quality of life and healthcare consumption among (pre) frail community-dwelling older persons at the one-year follow-up. Participants in the intervention group experienced improvements in walking speed, functional capacity and instrumental activities of daily living. More research is needed to better understand why may benefit and how to identify the target population.

RCT Entities:   Population Interventions Outcomes