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Intraclass Correlation Coefficients for Planning Cluster Randomized Trials in Community-Dwelling Older Adults.

ABSTRACT: Objectives: With the emerging trends, more cluster randomized trials will be conducted in older adults, where facilities are randomized rather than individuals. Similarity of individuals from a facility (intraclass correlation coefficient/ICC) plays a critical role, but not readily available. We document ICCs for measures commonly used in community-dwelling older adults and discuss implications. Method: Secondary analysis of a range of baseline measures from the On the Move cluster randomized trial, whose ICCs were computed using a linear mixed model. Results: Self-reported disability measures related to facility characteristics and sense of community had the greatest ICCs (>0.10), while mobility performance measures had 0.05 to 0.10, and cognitive measure 0.11. Discussion: The ICCs for measures commonly used in older adults are of a sufficient magnitude to have a substantial impact on planned sample size of a study and credibility of results, and should be taken into consideration in study planning and data analysis.

SUBMITTER: Perera S

PROVIDER: S-EPMC8012005 | biostudies-literature | 2020 Jun/Jul

REPOSITORIES: biostudies-literature

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Intraclass Correlation Coefficients for Planning Cluster Randomized Trials in Community-Dwelling Older Adults.

Perera Subashan S Nadkarni Neelesh K NK Wert David D VanSwearingen Jessie J Brach Jennifer S JS

Journal of aging and health 20181206 5-6

Objectives: With the emerging trends, more cluster randomized trials will be conducted in older adults, where facilities are randomized rather than individuals. Similarity of individuals from a facility (intraclass correlation coefficient/ICC) plays a critical role, but not readily available. We document ICCs for measures commonly used in community-dwelling older adults and discuss implications. Method: Secondary analysis of a range of baseline measures from the On the Move ...[more]

PMID: 30522389

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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.

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.

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).

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.

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Intraclass Correlation Coefficients for Planning Cluster Randomized Trials in Community-Dwelling Older Adults.

Publications

Intraclass Correlation Coefficients for Planning Cluster Randomized Trials in Community-Dwelling Older Adults.

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