GERAS Frailty Rehabilitation at Home During COVID-19
4 mars 2022 mis à jour par: Alexandra Papaioannou, McMaster University
GERAS Frailty Rehabilitation at Home: Virtual Bundled Care for Seniors Who Are Frail to Build Strength and Resilience During COVID-19
The coronavirus disease 2019 (COVID-19) pandemic is keeping people apart, which can take a toll on physical and mental health.
Many healthcare professionals are concerned vulnerable seniors may become deconditioned, which substantially increases risk of health complications and need for hospitalization.
To address the immediate impact of COVID-19 policies (i.e., physical distancing, reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors.
The investigators' aim is to understand how to best build resilience among vulnerable seniors in the community through at-home rehabilitation services (socialization, exercise, nutrition, and medication support).
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
During this unprecedented time of COVID-19, many healthcare professionals are concerned that vulnerable seniors who are housebound and isolated will become deconditioned resulting in functional losses in mental status, continence and ability to complete activities of daily living. Total inactivity in seniors can result in a 10-20% decrease in muscle strength per week (1 -3% per day). Loss of muscle strength may quickly convert a vulnerable older adult who was ambulatory into a bedridden state. This will affect the health of seniors and increase demand on healthcare systems. An innovative model to deliver frailty rehabilitation services remotely is urgently needed to: 1) increase access to specialized services 2) provide added supports for seniors discharged from the hospital who are in need of rehabilitation and 3) build resilience in seniors to prevent re-hospitalization or institutionalization. Therefore, to address the immediate impact of COVID-19 policies (i.e., physical distancing and reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors. This proof-of-concept, randomized control trial aims to understand how to best build resilience among vulnerable seniors through at-home rehabilitation services using socialization, exercise, nutrition, and medication support.
The short-term immediate goals for this RCT are to help vulnerable seniors who are isolated because of physical distancing measures to build strength and resilience throughout the COVID-19 pandemic. The major deliverables are 1) the adaptation of an in-person program to virtual delivery 2) the piloting of a care pathway with inter-disciplinary professionals that can be expanded to reach a larger number of individuals.
The long-term goal of the study is the seamless implementation of a new model for multimodal Frailty Rehabilitation that closes the care gap in rehabilitation for frail seniors in the immediate and foreseeable future.
Type d'étude
Interventionnel
Inscription (Réel)
70
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ontario
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Hamilton, Ontario, Canada, L8M1W9
- McMaster University - Hamilton Health Sciences (St. Peter's Site)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Community-dwelling adults aged ≥ 65 years of age;
- Score between 4-6 (inclusive) on the clinical frailty scale;
- Able to ambulate independently with or without a walking aid; OR with caregiver supervision at home;
- Obtain clearance for exercise: For hospital referrals - average resting heart rate between 50-100 bpm and average blood pressure less than or equal to 160/90mmHg (as per Canadian Society for Exercise Physiology guidelines for exercise clearance); OR Self- referrals: Obtain exercise clearance from their family physician prior to the first intervention session.
Exclusion Criteria:
- Unable to speak or understand English and has no caregiver for translation;
- Significant cognitive impairment where they may have difficulty following two-step commands;
- Receiving palliative/end of life care;
- Unstable angina or unstable heart failure;
- Travel plans that would result in missing greater than 20% of the trial's 12-week duration;
- Currently attending a group exercise program.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Socialization
Participants randomized to the socialization arm will receive once-weekly phone calls from medical student volunteers for a total of 12-weeks (n=35).
This program pairs health professional student volunteers with older adults in the community to provide social comfort while heightened physical distancing measures are in place during the current COVID-19 pandemic.
Attendance and duration of the phone calls will be logged.
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Social interaction is associated with better mental and physical health, and evidence suggests that group versus individual engagement may offer unique cognitive benefits for older adults as well as peer reinforcement and encouragement.
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Expérimental: Multi-Modal Frailty Rehabilitation
Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all through a videoconferencing system.
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Social interaction is associated with better mental and physical health, and evidence suggests that group versus individual engagement may offer unique cognitive benefits for older adults as well as peer reinforcement and encouragement.
Participants will receive twice-weekly (one hour per class) virtual exercise via small-group physiotherapy sessions for a total of 12 weeks.
All exercise sessions will occur virtually via a videoconferencing system.
The classes will focus on functional movements specifically designed for seniors with frailty and mobility challenges, and will include modifications for gait aids such as canes or walkers.
Class sizes will be small to allow for tailoring of exercises based on challenging, safe, progressive, evidence-based exercises.
In accordance with recent guidelines to achieve 3 hours/week for fall prevention practice in older adults, participants will also be provided with tailored supplemental home exercises developed by the study physiotherapist to gain an additional 1 hour of physical activity.
Nutrition Consult: Participants will be scheduled for a one-on-one virtual nutrition consult. During the consultation, study staff will assess the nutritional status of the participant and will provide them with counselling and coaching to improve their nutrition. Protein Supplementation: Oral nutrition supplements commercially available from Nestle will be provided unless contraindicated. The oral nutrition supplement contains 360 calories and 14 grams of protein per serving. Participants are advised to take this with a meal or within 3 hours of exercise on activity days.
A study pharmacist will review the participant's medication list and will utilize Beers and/or START/STOPP criteria to provide recommendations to optimize/update their medications to the participant's healthcare provider.
Study geriatricians will be listed as contacts on the primary care provider recommendations and available for consultation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Physical Function
Délai: Baseline and 12 Weeks Post-Intervention
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Assessed by the 5x Sit-to-Stand (time to complete).
Faster times to complete indicate better performance.
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Baseline and 12 Weeks Post-Intervention
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Change in Mental Health
Délai: Baseline and 12 Weeks Post-Intervention
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Assessed by the Depression Anxiety Stress Scale (DASS-21).
Higher scores indicate greater risk of depression, anxiety and stress [depression, anxiety, stress subscores range 0-21].
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Baseline and 12 Weeks Post-Intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Sarcopenia
Délai: Baseline and 12 Weeks Post-Intervention
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Assessed by the SARC-F - Self-reported strength, assistance with walking, rising from a chair, climbing stairs and falls.
Higher scores indicate greater level of sarcopenia [range 0-10].
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Baseline and 12 Weeks Post-Intervention
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Change in Frailty
Délai: Baseline and 12 Weeks Post-Intervention
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Assessed by the Fit-Frailty Index.
Higher scores indicate greater degree of frailty [range 0-1].
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Baseline and 12 Weeks Post-Intervention
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Change in Self-Efficacy
Délai: Baseline and 12 Weeks Post-Intervention
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Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABCs).
Higher scores indicate greater balance confidence [range 0-100].
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Baseline and 12 Weeks Post-Intervention
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Self-Reported Change in Function, Health and Well-Being
Délai: Baseline and 12 Weeks Post-Intervention
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Assessed by the interRAI Community Rehab Assessment - Self-Report
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Baseline and 12 Weeks Post-Intervention
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Clinician-Reported Change in Function, Health and Well-Being
Délai: Baseline and 12 Weeks Post-Intervention
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Assessed by the interRAI Community Rehab Assessment - Clinician-Completed
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Baseline and 12 Weeks Post-Intervention
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Change in Fitness
Délai: Weekly up to 12 weeks
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Assessed by the Borg Rate of Perceived Exertion after exercise.
Higher scores indicate greater level of exertion [range 6-20].
Also assessed using accelerometers (heart rate, sedentary time, physical activity time, energy expenditure).
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Weekly up to 12 weeks
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Program Satisfaction
Délai: 12 Weeks Post-Intervention
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Assessed using a program questionnaire in accordance with the Kirkpatrick 5-Level Evaluation Model.
Scores will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree".
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12 Weeks Post-Intervention
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Change in Health-Related Quality of Life
Délai: Baseline and 12 Weeks Post-Intervention
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Assessed by the EQ-5D-5L scale.
Lower scores indicate better self-reported quality of life [range 0-100].
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Baseline and 12 Weeks Post-Intervention
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Change in Nutrition
Délai: Baseline and 12 Weeks Post-Intervention
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Assessed by the Subjective Global Assessment.
Grades range from A-C where 'A' represents normal nutrition and 'C' represents severe malnourishment.
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Baseline and 12 Weeks Post-Intervention
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Change in Emergency Room Visits
Délai: Baseline and 12 Weeks Post-Intervention
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Number of emergency room visits will be recorded.
Higher number of emergency room visits indicates higher healthcare utilization.
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Baseline and 12 Weeks Post-Intervention
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Change in Hospitalizations
Délai: Baseline and 12 Weeks Post-Intervention
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Number of hospitalizations will be recorded.
Higher number of hospitalizations indicates higher healthcare utilization.
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Baseline and 12 Weeks Post-Intervention
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Change in Number of Calls to 911
Délai: Baseline and 12 Weeks Post-Intervention
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Number of calls to 911 will be recorded.
Higher number of calls indicates higher healthcare utilization.
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Baseline and 12 Weeks Post-Intervention
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility Outcome #1 - Reach of intervention
Délai: 12 Weeks Post-Intervention
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Assessed by the number of individuals who participated.
Target reach is 70 participants.
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12 Weeks Post-Intervention
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Feasibility Outcome #2 - Adoption of the Intervention
Délai: 12 Weeks Post-Intervention
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Assessed by number of referral sites.
Target is 5 referral sites.
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12 Weeks Post-Intervention
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Feasibility Outcome #3 - Implementation of the Intervention
Délai: 12 Weeks Post-Intervention
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Assessed by the number of individuals who completed the intervention.
Higher number of individuals completing the study indicates greater success in implementation.
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12 Weeks Post-Intervention
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Feasibility Outcome #4 - Maintenance of the Intervention
Délai: 12 Weeks Post-Intervention
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Assessed by the number of referral sites continuing with a second cohort.
Greater number of referral sites continuing with a second cohort indicates greater maintenance.
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12 Weeks Post-Intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Alexandra Papaioannou, MD, MSc, Scientific Director, GERAS Centre for Aging Research
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
26 août 2020
Achèvement primaire (Réel)
1 novembre 2021
Achèvement de l'étude (Réel)
1 novembre 2021
Dates d'inscription aux études
Première soumission
31 juillet 2020
Première soumission répondant aux critères de contrôle qualité
4 août 2020
Première publication (Réel)
5 août 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 mars 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 mars 2022
Dernière vérification
1 mars 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Infections à coronavirus
- Infections à Coronaviridae
- Infections à Nidovirales
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Pneumonie virale
- Pneumonie
- Maladies pulmonaires
- COVID-19 [feminine]
- Fragilité
Autres numéros d'identification d'étude
- 11408
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .