Intraclass Correlation Coefficients for Planning Cluster Randomized Trials in Community-Dwelling Older Adults.
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ABSTRACT:
SUBMITTER: Perera S
PROVIDER: S-EPMC8012005 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The aim of this study was to compute intra-class correlations (ICCs) for weight-related and patient-reported outcomes in a cluster randomized clinical trial (cRCT) for weight loss. Baseline and follow-up data from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cRCT were used in this analysis. ICCs were computed for baseline and follow-up measures, and changes in body weight, cardiometabolic risk factors and health-related and weight-related quality of life at 6, 12, 18 and 24 months. Baseline ICCs ranged from 0 for PROMIS measures of anxiety and fatigue to 0.055 for total cholesterol (median = 0.019). The ICCs were higher for changes and decreased over time during follow-up. The ICCs for changes were highest in the pooled sample (intervention and usual care combined) followed by the intervention and usual care groups, respectively. The results demonstrated significant ICCs for several outcomes in a weight loss cRCT. The ICCs differed in magnitude depending on whether baseline versus longitudinal data were used, whether data were combined across treatment arms or were considered separately, and varied across the follow-up period. All these factors must be considered when choosing an ICC to inform sample size estimates for future weight loss cRCTs conducted in primary care settings.
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Project description:BackgroundIn longevity societies, one of the most serious social issues is sarcopenia and/or frailty. Preventing them is important for maintaining independence and quality of life in the older population. This study investigated the effect of a self-monitoring comprehensive geriatric intervention programme (CGIP) on physical function and muscle size in community-dwelling older adults. We compared the effects of a CGIP using weekly class-styled (CS) sessions and a home-based (HB) programme.MethodsThe 526 participants were randomized into one of two groups (CS 251, HB 275) based on their residential districts. We conducted a 12 week CGIP, which consisted of low-load resistance exercise, physical activity increments, oral function improvements, and a nutritional guide. All participants were encouraged to attend two 90 min lectures that included instructions on the CGIP. They were provided with exercise materials (triaxial-accelerometers/pedometers, ankle weights, and elastic bands) and diary logs. The CS group attended 90 min weekly sessions and independently executed the programme on other days, whereas the HB group only received instructions on how to execute the programme. Physical functions, such as knee extension strength (KES), normal and maximum walking speed, the timed up-and-go test, and anterior thigh muscle thickness (MT), were measured and analysed using intention-to-treat analysis before and after the 12 week intervention.ResultsOf the 526 participants identified, 517 (CS 243 age 74.0 ± 5.4 women 57.2%, HB 274 age 74.0 ± 5.6 women 58.8%) were enrolled. Nine (CS 8, HB 1) were excluded from the analysis because they did not participate in the pre-intervention measurements. Both interventions significantly improved KES (CS 18.5%, HB 10.6%), normal walking speed (CS 3.7%, HB 2.8%), and MT (CS 3.2%, HB 3.5%). Greater improvement of KES was observed in the CS group (P = 0.003). Maximum walking speed (CS 4.7%, HB 1.8%; P = 0.001) and timed up-and-go (CS -4.7%, HB -0.2%; P < 0.001) significantly improved in the CS group only.ConclusionsThe intervention was effective in preventing sarcopenia and/or frailty. Most physical functions and MT improved after both interventions. The HB intervention is cost-effective and may help prevent sarcopenia and/or frailty in the large older population.
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Project description:This concerns a cross-sectional cohort study of 356 Dutch community-dwelling older adults to study the association of the oral microbiota with poor taste, poor smell, poor appetite and undernutrition. Data-collection consisted of body measurements (incl. body weight, height, and body impedance analysis), extensive appetite and food frequency questionnaires, taste and smell tests, and a tongue swab. The oral microbiota composition was assessed with 16S rRNA sequencing.
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Project description:Pressure-mediated reflection spectroscopy (RS) measures skin carotenoid content (SCC). Continued validation of this method is pertinent to validate its use as an objective measure of fruit and vegetable intake. This study aimed to assess relationships between SCC scores and self-reported dietary carotenoid intake from 3-day food records in community dwelling older adults. This was a cross-sectional analysis of baseline data among cognitively normal older adults (n=95) participating in the Nutrition Interventions for Cognitive Enhancement (NICE) study. Food-derived vitamin A (R=0.24, p<0.05) and food plus supplemental vitamin A (R=0.29, p<0.01) were correlated with SCC. All food-derived carotenoids (R: 0.20-0.39, p<0.05) except beta-cryptoxanthin and lycopene were correlated with SCC. Lutein + zeaxanthin from food more strongly correlated with SCC (R=0.38, p<0.001) than combined food plus supplemental intake (R=0.31, p=0.002). Correlations for total fruit and SCC (R=0.23, p=0.02), total vegetable and SCC (R= 0.31, p=0.002), and combined total fruit and vegetable and SCC (R=0.35, p<0.001) were significant; no sub-categories of fruit or vegetables except dark green vegetables (Rho=0.4, p<0.001) had significant correlations with SCC. The current study demonstrates RS-derived SCC scores correlate with 3-day self-reported intakes of F/V and certain carotenoids in community dwelling older adults.
| S-EPMC8594869 | biostudies-literature
Project description:BackgroundMost randomised controlled trials on advance care planning were conducted in people with advanced, life-limiting illnesses or in institutional settings. There are few studies on its effect in older people living in the community.AimTo determine the effects of advance care planning in older community dwelling people.DesignThe STADPLAN study was a cluster-randomised trial with 12 months follow-up. The complex intervention comprised a 2-days training for nurse facilitators that delivered a formal advance care planning counselling and a written information brochure. Patients in the control group received optimised usual care, that is, provision of a short information brochure.Setting/participantsHome care services in three regions of Germany were randomised using concealed allocation. Care dependent clients of participating home care services, aged 60 years or older, and rated to have a life-expectancy of at least 4 weeks were included. Primary outcome was active participation in care at 12 months, assessed by blinded investigators using the Patient Activation Measure (PAM-13).ResultsTwenty-seven home care services and 380 patients took part. Three hundred seventy-three patients were included in the primary analysis (n = 206 in the intervention and n = 167 in the control group). There was no statistically significant difference between the intervention and control group with regard to the PAM-13 after 12 months (75.7 vs 78.4; p = 0.13). No differences in quality of life, anxiety and depression, advance care planning engagement, and in proportion of participants with advance directives were found between groups.ConclusionsThe intervention showed no relevant effects on patient activation or quality of life in community dwelling older persons, possibly indicating the need for more tailored interventions. However, results are limited by a lack of statistical power.Trial registrationGerman Clinical Trials Register: DRKS00016886.
| S-EPMC10503242 | biostudies-literature
Project description:The presence of olfactory dysfunction in individuals at higher risk of Alzheimer's disease has significant diagnostic and screening implications for preventive and ameliorative drug trials. Olfactory threshold, discrimination and identification can be reliably recorded in the early stages of neurodegenerative diseases. The current study has examined the ability of various olfactory functions in predicting cognitive decline in a community-dwelling sample. A group of 308 participants, aged 46-86 years old, were recruited for this study. After 3 years of follow-up, participants were divided into cognitively declined and non-declined groups based on their performance on a neuropsychological battery. Assessment of olfactory functions using the Sniffin' Sticks battery indicated that, contrary to previous findings, olfactory discrimination, but not olfactory identification, significantly predicted subsequent cognitive decline (odds ratio = 0.869; P<0.05; 95% confidence interval = 0.764-0.988). The current study findings confirm previously reported associations between olfactory and cognitive functions, and indicate that impairment in olfactory discrimination can predict future cognitive decline. These findings further our current understanding of the association between cognition and olfaction, and support olfactory assessment in screening those at higher risk of dementia.
| S-EPMC3365262 | biostudies-other
Project description:BACKGROUND:Concern has been expressed that preventive measures in older people might increase frailty by increasing survival without improving health. We investigated the impact of exercise on the probabilities of health improvement, deterioration and death in community-dwelling older people. METHODS AND PRINCIPAL FINDINGS:In the Canadian Study of Health and Aging, health status was measured by a frailty index based on the number of health deficits. Exercise was classified as either high or low/no exercise, using a validated, self-administered questionnaire. Health status and survival were re-assessed at 5 years. Of 6297 eligible participants, 5555 had complete data. Across all grades of frailty, death rates for both men and women aged over 75 who exercised were similar to their peers aged 65 to 75 who did not exercise. In addition, while all those who exercised had a greater chance of improving their health status, the greatest benefits were in those who were more frail (e.g. improvement or stability was observed in 34% of high exercisers versus 26% of low/no exercisers for those with 2 deficits compared with 40% of high exercisers versus 22% of low/no exercisers for those with 9 deficits at baseline). CONCLUSIONS:In community-dwelling older people, exercise attenuated the impact of age on mortality across all grades of frailty. Exercise conferred its greatest benefits to improvements in health status in those who were more frail at baseline. The net effect of exercise should therefore be to improve health status at the population level.
| S-EPMC2702830 | biostudies-literature
Project description:BackgroundIncreasingly, researchers are recognizing that there are many situations where the use of a cluster randomized trial may be more appropriate than an individually randomized trial. Similarly, the need for appropriate standards of reporting of cluster trials is more widely acknowledged.MethodsIn this paper, we describe the results of a survey to inform the appropriate reporting of the intracluster correlation coefficient (ICC)--the statistical measure of the clustering effect associated with a cluster randomized trial.ResultsWe identified three dimensions that should be considered when reporting an ICC--a description of the dataset (including characteristics of the outcome and the intervention), information on how the ICC was calculated, and information on the precision of the ICC.ConclusionsThis paper demonstrates the development of a framework for the reporting of ICCs. If adopted into routine practice, it has the potential to facilitate the interpretation of the cluster trial being reported and should help the development of new trials in the area.
| S-EPMC415547 | biostudies-literature
Project description:BackgroundWith the advancing age of the population, and increasing demands on healthcare services, community participation has become an important consideration for healthy ageing. Low levels of community participation have been linked to increased mortality and social isolation. The extent to which community participation has been measured objectively in older adults remains scarce. This study aims to describe where and how older adults participate in the community and determine the feasibility of measurement methods for community participation.MethodsThis observational cross-sectional study obtained data from 46 community dwelling older adults. A combination of Global Positioning Systems (GPS), accelerometry, and self-reported diaries were used over a 7-day monitoring period. Feasibility of methods were determined by calculating the loss of GPS data, questionnaires, and comparison of self-reported locations with GPS co-ordinates. Relationships between community participation, physical activity, social interactions, health related quality of life, sleep quality and loneliness were explored.ResultsOlder adults took a median (IQR) of 15 (9.25-18.75) trips out of home over the 7-day monitoring period, most frequently visiting commercial and recreational locations. In-home activities were mainly sedentary in nature, with out of home activities dependent on location type. Self-reported and GPS measures of trips out of home and the locations visited were significantly correlated (self-report 15.7 (5.6) GPS 14.4 (5.8) (r = 0.94)). Significant correlations between both the number of trips taken from home, with social interactions (r = 0.62) and the minutes of moderate to vigorous physical activity (MVPA) (r = 0.43) were observed. Daily MVPA was higher in participants who visited local walk/greenspaces (r = 0.48).ConclusionParticipants performed more activities with social interactions out of home and visited commercial locations most frequently. The combination of GPS, accelerometry and self-report methods provided a detailed picture of community participation for older adults. Further research is required with older adults of varying health status to generalise the relationships between community participation, location and physical activity.Trial registrationEthical approval was gained from the Flinders University Social and Behavioural Research Ethics Committee (protocol no. 8176).
| S-EPMC8008662 | biostudies-literature
Project description:BackgroundEffective and sustainable interventions are needed to counteract the decline in physical function and sarcopenia in the growing aging population. The aim of this study was to determine the 6 and 12 month effectiveness of blended (e-health + coaching) home-based exercise and a dietary protein intervention on physical performance in community-dwelling older adults.MethodsThis cluster randomized controlled trial allocated 45 clusters of older adults already engaged in a weekly community-based exercise programme. The clusters were randomized to three groups with ratio of 16:15:14; (i) no intervention, control (CON); (ii) blended home-based exercise intervention (HBex); and (iii) HBex with dietary protein counselling (HBex-Pro). Both interventions used a tablet PC with app and personalized coaching and were targeting on behaviour change. The study comprised coached 6 month interventions with a 6 month follow-up. The primary outcome physical performance was assessed by modified Physical Performance Test (m-PPT). Secondary outcomes were gait speed, physical activity level (PAL), handgrip muscle strength, protein intake, skeletal muscle mass, health status, and executive functioning. Linear mixed models of repeated measured were used to assess intervention effects at 6 and 12 months.ResultsThe population included 245 older adults (mean age 72 ± 6.5 (SD) years), 71% female, and 54% co-morbidities observed. Dropout of the intervention was 18% at 6 months and 26% at 12 months. Participants were well functioning, based on an m-PPT score of 33.9 (2.8) out of 36. For the primary outcome m-PPT, no significant intervention effects (HBex, +0.03, P = 0.933; HBex-Pro, -0.13, P = 0.730) were found. Gait speed (+0.20 m/s, P = 0.001), PAL (+0.06, P = 0.008), muscle strength (+2.32 kg, P = 0.001), protein intake (+0.32 g/kg/day, P < 0.001), and muscle mass (+0.33 kg, P = 0.017) improved significantly in the HBex-Pro group compared with control group after 6 month intervention. The protein intake, muscle mass, and strength remained significantly improved after 12 months as compared with those of control. Health change and executive functioning improved significantly in both intervention groups after 6 months.ConclusionsThis HBex and dietary protein interventions did not change the physical performance (m-PPT) in community-dwelling older adults. Changes were observed in gait speed, PAL, muscle mass, strength, and dietary protein intake, in response to this combined intervention.
| S-EPMC7749597 | biostudies-literature