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Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032].

ABSTRACT: Concerns about falls are frequently reported by older people. These concerns can have serious consequences such as an increased risk of falls and the subsequent avoidance of activities. Previous studies have shown the effectiveness of a multicomponent group programme to reduce concerns about falls. However, owing to health problems older people may not be able to attend a group programme. Therefore, we adapted the group approach to an individual in-home programme.A two-group randomised controlled trial has been developed to evaluate the in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail older people living in the community. Persons were eligible for study if they were 70 years of age or over, perceived their general health as fair or poor, had at least some concerns about falls and associated avoidance of activity. After screening for eligibility in a random sample of older people, eligible persons received a baseline assessment and were subsequently allocated to the intervention or control group. Persons assigned to the intervention group were invited to participate in the programme, while those assigned to the control group received care as usual. The programme consists of seven sessions, comprising three home visits and four telephone contacts. The sessions are aimed at instilling adaptive and realistic views about falls, as well as increasing activity and safe behaviour. An effect evaluation, a process evaluation and an economic evaluation are conducted. Follow-up measurements for the effect evaluation are carried out 5 and 12 months after the baseline measurement. The primary outcomes of the effect evaluation are concerns about falls and avoidance of activity as a result of these concerns. Other outcomes are disability and falls. The process evaluation measures: the population characteristics reached; protocol adherence by facilitators; protocol adherence by participants (engagement in exposure and homework); opinions about the programme of participants and facilitators; perceived benefits and achievements; and experienced barriers. The economic evaluation examines the impact on health-care utilisation, as well as related costs.A total number of 389 participants is included in the study. Final results are expected in 2012.NCT01358032.

SUBMITTER: Dorresteijn TA

PROVIDER: S-EPMC3189875 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature

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Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032].

Dorresteijn Tanja A C TA Zijlstra G A Rixt GA Delbaere Kim K van Rossum Erik E Vlaeyen Johan W S JW Kempen Gertrudis I J M GI

BMC health services research 20110920

<h4>Background</h4>Concerns about falls are frequently reported by older people. These concerns can have serious consequences such as an increased risk of falls and the subsequent avoidance of activities. Previous studies have shown the effectiveness of a multicomponent group programme to reduce concerns about falls. However, owing to health problems older people may not be able to attend a group programme. Therefore, we adapted the group approach to an individual in-home programme.<h4>Methods/d ...[more]

PMID: 21933436

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Project description:BackgroundConcerns about falls are common among older people. These concerns, also referred to as fear of falling, can have serious physical and psychosocial consequences, such as functional decline, increased risk of falls, activity restriction, and lower social participation. Although cognitive behavioral group programs to reduce concerns about falls are available, no home-based approaches for older people with health problems, who may not be able to attend such group programs are available yet. The aim of this study was to assess the effectiveness of a home-based cognitive behavioral program on concerns about falls, in frail, older people living in the community.MethodsIn a randomized controlled trial in the Netherlands, 389 people aged 70 years and older, in fair or poor perceived health, who reported at least some concerns about falls and related activity avoidance were allocated to a control (n?=?195) or intervention group (n?=?194). The intervention was a home-based, cognitive behavioral program consisting of seven sessions including three home visits and four telephone contacts. The program aims to instill adaptive and realistic views about fall risks via cognitive restructuring and to increase activity and safe behavior using goal setting and action planning and was facilitated by community nurses. Control group participants received usual care. Outcomes at 5 and 12 months follow-up were concerns about falls, activity avoidance due to concerns about falls, disability and falls.ResultsAt 12 months, the intervention group showed significant lower levels of concerns about falls compared to the control group. Furthermore, significant reductions in activity avoidance, disability and indoor falls were identified in the intervention group compared with the control group. Effect sizes were small to medium. No significant difference in total number of falls was noted between the groups.ConclusionsThe home-based, cognitive behavioral program significantly reduces concerns about falls, related activity avoidance, disability and indoor falls in community-living, frail older people. The program may prolong independent living and provides an alternative for those people who are not able or willing to attend group programs.Trial registrationClinicalTrials.gov, NCT01358032. Registered 17 May 2011.

Project description:BACKGROUND:Due to the demographic ageing process and the increasing number of pre-frail and frail individuals, new lifestyle interventions to enhance the quality of life (QoL) in community-dwelling older adults are necessary. Therefore, we performed a randomised controlled trial (RCT) to compare effects of a lay-led home-based physical and nutritional intervention programme with social support alone on different QoL domains in community-dwelling pre-frail and frail older adults. METHODS:In this analysis within a RCT (12 weeks), lay volunteers visited one-on-one pre-frail or frail older adults at home twice a week. Participants in the physical training and nutritional intervention (PTN) group performed six strength exercises and discussed main nutritional issues during each visit. The social support (SOSU) group received home visits twice a week for social exchanges. The QoL was assessed with the WHOQOL-BREF and the WHOQOL-OLD instruments. Analyses of covariance (ANCOVA) were used to examine differences between groups with baseline values as the covariate. Changes within groups were assessed with paired t-tests. RESULTS:Eighty participants (n = 39 in the PTN group and n = 41 in the SOSU group) were included. No significant differences were found between the two groups except in past, present and future activities domain [? = 3.66 (95% confidence interval 0.13 to 7.18)] in favour of the PTN group. However, there was some evidence of greater within group improvements in the PTN group particularly in overall QoL, social relations and social participation. In the SOSU group, no significant effect was observed in any QoL domain. CONCLUSION:A combination of a home-based physical and nutritional intervention was not more effective compared to social support alone, on QoL in community-dwelling pre-frail and frail older adults. However, the small but significant improvement within the PTN group suggests that a home-based physical and nutritional intervention delivered by volunteers may influence the QoL in a positive way. TRIAL REGISTRATION:The study protocol was registered on 6 November 2013 at ClinicalTrials.gov (identifier: NCT01991639 ).

Project description:ImportanceFalls are the leading preventable cause of morbidity, mortality, and premature institutionalization for community-dwelling older adults.ObjectiveTo test the effectiveness of a behavioral intervention on fall risk among older adults receiving services from an Area Agency on Aging.Design, setting, and participantsThis randomized clinical trial examined a home hazard removal intervention in the community using a race- and sex-stratified randomization design. Older adults receiving services from the Area Agency on Aging in urban St Louis, Missouri, were assigned to a home hazard removal intervention delivered over 2 weeks with a 6-month booster or usual care control. Eligible participants were adults aged 65 years or older who did not have dementia, were at high risk for falling, and resided in the community. Enrollment occurred from January 2015 to September 2016; 12-month follow-up occurred from February 2016 to October 2017. Data were analyzed from February 2019 to July 2021.InterventionsThe intervention was a home hazard removal program delivered by an occupational therapist in the home that included a comprehensive clinical assessment and a tailored hazard removal plan. Usual care control consisted of annual assessments and community referral.Main outcomes and measuresThe primary outcome was the hazard of a fall over 12 months. Prespecified secondary outcomes included the rate of falls over 12 months, daily activity performance, falls self-efficacy, and self-reported quality of life.ResultsA total of 310 participants (mean [SD] age, 75 [7.4] years; 229 [74%] women; 161 Black participants [52%]) were randomized, with 155 participants assigned to the intervention and 155 participants assigned to usual care. Retention was 127 participants (82%) in the intervention group and 126 participants (81%) in the control group. There was no difference for our primary outcome of fall hazard (hazard ratio, 0.90; 95% CI, 0.66-1.27). There was a 38% reduction in the rate of falling in the intervention group compared with the control group (relative risk, 0.62; 95% CI, 0.40-0.95; P = .03). At 12 months, the rate of falls per person-year was 1.5 (95% CI, 1.32-1.75) in the intervention group and 2.3 (95% CI, 2.08-2.60) in the control group. There was no difference in daily activity performance (adjusted difference, -0.20; 95% CI, -0.95 to 0.55; P = .60), falls self-efficacy (adjusted difference, -0.12; 95% CI, -1.25 to 1.01; P = .84), or quality of life (adjusted difference, 0.84; 95% CI, -0.95 to 2.64; P = .35).Conclusions and relevanceThis randomized clinical trial found that a brief home hazard removal program did not reduce the hazard of falls among community-dwelling older adults at high risk for falling. The intervention was effective in achieving a reduced rate of falls, a prespecified secondary outcome. This effectiveness study has the potential for delivery through the national aging services network.Trial registrationClinicalTrials.gov Identifier: NCT02392013.

Project description:Care of frail and dependent older adults with multiple chronic conditions is a major challenge for health care systems. The study objective was to test the efficacy of providing integrated care at home to reduce unnecessary hospitalizations, emergency room visits, institutionalization, and mortality in community dwelling frail and dependent older adults.A prospective controlled trial was conducted, in real-life clinical practice settings, in a suburban region in Geneva, Switzerland, served by two home visiting nursing service centers. Three hundred and one community-dwelling frail and dependent people over 60 years old were allocated to previously randomized nursing teams into Control (N?=?179) and Intervention (N?=?122) groups: Controls received usual care by their primary care physician and home visiting nursing services, the Intervention group received an additional home evaluation by a community geriatrics unit with access to a call service and coordinated follow-up. Recruitment began in July 2009, goals were obtained in July 2012, and outcomes assessed until December 2012. Length of follow-up ranged from 5 to 41 months (mean 16.3). Primary outcome measure was the number of hospitalizations. Secondary outcomes were reasons for hospitalizations, the number and reason of emergency room visits, institutionalization, death, and place of death.The number of hospitalizations did not differ between groups however, the intervention led to lower cumulative incidence for the first hospitalization after the first year of follow-up (69.8%, CI 59.9 to 79.6 versus 87?·?6%, CI 78?·?2 to 97?·?0; p?=?.01). Secondary outcomes showed that the intervention compared to the control group had less frequent unnecessary hospitalizations (4.1% versus 11.7%, p?=?.03), lower cumulative incidence for the first emergency room visit, 8.3%, CI 2.6 to 13.9 versus 23.2%, CI 13.1 to 33.3; p?=?.01), and death occurred more frequently at home (44.4 versus 14.7%; p?=?.04). No significant differences were found for institutionalization and mortality.Integrated care that included a home visiting multidisciplinary geriatric team significantly reduced unnecessary hospitalizations, emergency room visits and allowed more patients to die at home. It is an effective tool to improve coordination and access to care for frail and dependent older adults.Clinical Trials.gov Identifier: NCT02084108 . Retrospectively registered on March 10th 2014.

Dataset Information

Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032].

Publications

Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032].

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