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- Registre américain des essais cliniques
- Essai clinique NCT06415604
Home-based Psychoeducation for Older Adults With Frailty
Effets d'une psychoéducation à domicile sur le bien-être subjectif des personnes âgées fragiles dans la communauté : un essai contrôlé randomisé
This study aims to examine the effectiveness of a 12-week home-based telerehabilitation programme on improving subjective well-being among community-dwelling older people with frailty.
The main question it aims to answer is
- Could home-based psychoeducation significantly enhance subjective well-being in older adults with frailty in the community?
Participants will receive 12 weekly online group-based sessions at their homes. The content for the experimental group and control group is different:
- Intervention group: psychoeducation
- Control group: physical health education Participants will receive three home visits for data collection. Some of participants in experimental group will receive interview for process evaluation.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
New Territories
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Shatin, New Territories, Hong Kong
- The Nethersole School of Nursing, The Chinese University of Hong Kong
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Aged 65 years or over
- Meeting frailty criteria by FRAIL scale (score 3 or above)
- Mentally competent screened by The Abbreviated Mental Test (AMT ≥ 6)
- Able to speak and understand Cantonese
- Living at home
- Having experience using a smartphone (e.g., sending messages, watching videos)
Exclusion Criteria:
- A visual or hearing problem or a language barrier that may affect their communication or understanding
- A life expectancy of less than 6 months
- Engaged in 150 minutes or more of exercise per week
- Undergoing psychiatric treatment or taking antidepressant medication, or participating in other studies
- Have undergone major surgery in the past six months or are scheduled for major surgery in the next six months
- Any of the following conditions against physical exercises:
- Acute myocardial infarction or recent unstable angina
- Uncontrolled atrial/ventricular arrhythmias
- Dissecting aortic aneurysm
- Severe aortic stenosis
- Endocarditis/acute pericarditis
- Uncontrolled hypertension
- Acute thromboembolic events
- Acute or severe heart failure
- Acute or severe respiratory failure
- Uncontrolled orthostatic hypotension
- Acute decompensated diabetes or uncontrolled hypoglycemia
- A fracture in the past month
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Experimental group
Participants will receive 60-minute weekly online group-based psychoeducation sessions for 12 weeks. |
The content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving". |
|
Comparateur actif: Control group
Participants will receive 60-minute weekly online group-based physical health sessions for 12 weeks. |
The content of the sessions mainly focuses on physical health information, such as healthy eating, physical exercise, prevention of falls, and pain management. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Subjective well-being
Délai: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
The Chinese 5-item World Health Organization Well-Being Index: scores range from 0 to 25. Higher scores indicate greater levels of subjective well-being |
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physical functioning
Délai: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
The Senior Fitness Test: It include seven test: the 30-sec arm-curl test, 30-sec chair-stand test, back-scratch test, chair sit-and-reach test, 8-foot up-and-go test, two-min step test, BMI |
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
|
Activities of daily living
Délai: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Katz Index of Independence in Activities of Daily Living: scores range from 0 to 12. Higher scores indicate greater independence |
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
|
Instrumental activities of daily living
Délai: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Lawton Instrumental Activities of Daily Living Scale: scores range from 0 to 8. Higher scores indicate greater independence |
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
|
Depressive symptoms
Délai: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
4-item Geriatric Depression scale: scores range from 0 to 4. Higher scores indicate higher level of depressive symptoms |
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
|
Social support
Délai: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
10-item Duke Social Support Index: scores range from 10 to 30. Higher scores on the DSSI-10 indicate better perceived social support |
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
|
Health-related Quality of life
Délai: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
EuroQol 5-Dimension 5-Level: scores range from -0.865 to 1. Higher scores indicate better health-related quality of life |
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2023.585.M
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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