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A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients.

ABSTRACT: BACKGROUND:Physical function declines during hospitalization in geriatric patients, increasing the risk of loss of independence. There is a need for evidence-based, pragmatic interventions to improve functional recovery of older adults following acute hospitalization. Here, we report the results of a Phase I randomized clinical trial designed to determine safety and effect size of protein supplementation, exercise, and testosterone interventions on 30-day post-discharge functional recovery and readmissions in geriatric patients. METHODS:A total of 100 patients admitted to the University of Texas Medical Branch hospital for an acute medical illness were randomized to one of five intervention groups: isocaloric placebo, whey protein supplement, in-home rehabilitation + placebo, in-home rehabilitation + whey protein, or testosterone. Primary outcome measure was the change from baseline in short physical performance battery score at 1 and 4 weeks post-discharge. Secondary outcomes were changes in body composition, activities of daily living, and 30-day readmissions. Comparisons were made across study groups and between placebo and all active intervention groups. RESULTS:Four weeks post-discharge, the short physical performance battery total score and balance score increased more in active intervention groups than placebo group (p < .05). There were no significant differences in change in body composition or activities of daily living across groups or between active intervention groups and placebo group. Readmission rates were highest in placebo (28%), followed by rehabilitation + placebo (15%), whey protein (12%), rehabilitation + whey protein (11%), and testosterone (5%). There was a trend for lower readmission rates in all active intervention groups (11%) versus placebo group (28%). CONCLUSIONS:Findings from this Phase I clinical trial suggest that pragmatic, evidence-based interventions may accelerate recovery from acute hospitalization in geriatric patients. These data provide essential information to design larger randomized controlled trials to test the effectiveness of these interventions.

SUBMITTER: Deer RR

PROVIDER: S-EPMC6748704 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients.

Deer Rachel R RR Dickinson Jared M JM Baillargeon Jacques J Fisher Steven R SR Raji Mukaila M Volpi Elena E

The journals of gerontology. Series A, Biological sciences and medical sciences 20190901 10

<h4>Background</h4>Physical function declines during hospitalization in geriatric patients, increasing the risk of loss of independence. There is a need for evidence-based, pragmatic interventions to improve functional recovery of older adults following acute hospitalization. Here, we report the results of a Phase I randomized clinical trial designed to determine safety and effect size of protein supplementation, exercise, and testosterone interventions on 30-day post-discharge functional recove ...[more]

PMID: 30906944

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Project description:BackgroundHospitalization is a major risk factor for functional decline, disability, loss of independence, and mortality in older adults. Evidence-based interventions to improve functional recovery from hospitalization are difficult to evaluate and implement in geriatric patients. The goal of this pilot study was to test the feasibility of recruiting geriatric inpatients and implementing pragmatic interventions to improve physical function following hospitalization.MethodsEnrolled subjects were randomized to one of five 30-day posthospitalization interventions: isocaloric placebo (P), whey protein supplement (W), in-home rehabilitation+placebo (R+P), rehabilitation+whey protein (R+W), or testosterone (T). Data were collected from a single-site university hospital to determine: (i) institution-based feasibility (nonmodifiable factors including number of patients screened, eligible, contacted) and (ii) patient-based feasibility (modifiable factors including number of patients refusing, enrolled, randomized, intervention adherence, and withdrawal).ResultsFrom January 2014 to July 2016, 4,533 patients were chart screened; 594 (13.1%) were eligible to participate; 384 eligible subjects were contacted; 113 were enrolled; and 100 were randomized. Supplement adherence was 75% and was not different by age, education, level of independence, depression, supplement type, or dual intervention, but was significantly higher in subjects who completed the intervention (p < .01). Rehabilitation session adherence was 77% and did not vary significantly by age, education, level of independence, depression, or supplement type, but was significantly higher for sessions directly supervised (p < .01). Adherence was 100% in the testosterone arm with 94.7% of injections given within 24 hours of discharge.ConclusionsFindings from this clinical trial indicate that posthospitalization interventions in geriatric patients are feasible at both the institution and patient level.

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:BackgroundAlthough assessment of geriatric syndromes is increasingly encouraged in older adults, little evidence exists to support its systematic use by general practitioners (GPs). The aim of this study was to determine whether a systematic geriatric evaluation performed by GPs can prevent functional decline.MethodsWe conducted a controlled, open-label, pragmatic cluster-randomized trial in 42 general practices in Switzerland. Participating GPs were expected to enrol an average of 10 community-dwelling adults (aged ≥ 75 yr) who understood French, and had visited their GP at least twice in the previous year. The intervention consisted of yearly assessment by the GP of 8 geriatric syndromes with an associated tailored management plan according to assessment results, compared with routine care. Our primary outcomes were the proportion of patients who lost at least 1 instrumental activity of daily living (ADL) and the proportion who lost at least 1 basic ADL, over 2 years. Our secondary outcomes were quality-of-life scores, measured using the older adult module of the World Health Organization Quality of Life Instrument, and health care use.ResultsForty-two GPs recruited 429 participants (63% women) with a mean age of 82.5 years (standard deviation 4.8 yr) at time of recruitment. Of these, we randomly assigned 217 participants to the intervention and 212 to the control arm. The proportion of patients who lost at least 1 instrumental ADL in the intervention and control arms during the course of the study was 43.6% and 47.6%, respectively (risk difference -4.0%, 95% confidence interval [CI] -14.9% to 6.7%, p = 0.5). The proportion of patients who lost at least 1 basic ADL was 12.4% in the intervention arm and 16.9% in the control arm (risk difference -5.1%, 95% CI -14.3% to 4.1%, p = 0.3).InterpretationA yearly geriatric evaluation with an associated management plan, conducted systematically in GP practices, does not significantly lessen functional decline among community-dwelling, older adult patients, compared with routine care.Trial registrationClinicalTrials.gov, NCT02618291.

Project description:ObjectiveTo identify functional performance trajectories and the characteristics of people who receive inpatient geriatric rehabilitation after hospital admissions.Design, setting, participantsREStORing health of acutely unwell adulTs (RESORT) is an observational, prospective, longitudinal inception cohort study of consecutive patients admitted to geriatric rehabilitation wards at the Royal Melbourne Hospital. Recruitment commenced on 15 October 2017.Main outcome measuresFunctional performance, assessed with the Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales two weeks before acute hospitalisation, on admission to and discharge from geriatric rehabilitation, and three months after discharge from geriatric rehabilitation.ResultsA total of 618 rehabilitation patients were included in our analysis. For each of the two scales, three distinct functional performance trajectories were identified by latent class growth modelling: poor at baseline and 3-month follow-up (remained poor: ADL, 6.6% of patients; IADL, 42%), good at baseline but poor recovery (deteriorated: ADL, 33%; IADL, 20%), and good at baseline and good recovery (recovered: ADL, 60%; IADL, 35%). Higher Clinical Frailty Scale (CFS) score (v recovered, per point: odds ratio [OR], 2.51; 95% CI, 1.64-3.84) and cognitive impairment (OR, 6.33; 95% CI, 2.09-19.1) were associated with greater likelihood of remaining poor in ADL, and also with deterioration (CFS score: OR, 1.76; 95% CI, 1.45-2.13; cognitive impairment: OR, 1.87; 95% CI, 1.24-2.82). Higher CFS score (OR, 1.64; 95% CI, 1.37-1.97) and cognitive impairment (OR, 3.60; 95% CI, 2.31-5.61) were associated with remaining poor in IADL, and higher CFS score was also associated with deterioration (OR, 1.63; 95% CI, 1.33-1.99).ConclusionsBased on ADL assessments, most people who underwent inpatient geriatric rehabilitation regained their baseline functional performance. As higher CFS score and cognitive impairment were associated with poorer functional recovery, assessing frailty and cognition at hospital admission could assist intervention and discharge planning.

Project description:Mindfulness interventions have been shown to improve several subcomponents of attention; however, the psychological mechanisms driving these improvements are unknown. Mindfulness interventions train individuals to monitor present moment experiences while adopting an attitude of acceptance toward these experiences. We conducted a theoretically driven randomized controlled trial to test the putative mechanisms of mindfulness training that drive improvements in attentional control. Participants were randomly assigned to 1 of 3 conditions: (a) monitor and accept (MA) training, a standard 8-week mindfulness-based stress reduction (MBSR) intervention that included cultivation of both monitoring and acceptance skills; (b) monitor only (MO) training, a well-matched modified 8-week MBSR-adapted intervention that focused on monitoring skills only; or (c) no treatment (NT) control. Momentary attentional control was measured via ecological momentary assessment for 3 days at baseline and postintervention. Trait attentional control was assessed at baseline and postintervention using traditional self-report. Participants also completed a dichotic listening task to assess sustained attention at baseline and postintervention. We found that MA and MO participants improved in momentary and trait attentional control (but not attention task performance) relative to NT participants. Analyses of indirect effects were consistent with the possibility that increased momentary attentional control partially accounts for MA/MO intervention-related increases in trait attentional control. This randomized controlled trial provides one of the first experimental tests of the mechanisms of mindfulness interventions that drive improvements in attention outcomes. These findings support the notion that present-focused monitoring skills training drives mindfulness intervention-related improvements in momentary attentional control, which in turn fosters greater trait attentional control. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

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A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients.

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A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients.

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