- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06415604
Home-based Psychoeducation for Older Adults With Frailty
Effekter av en hjemmebasert psykoedukasjon på subjektivt velvære for eldre voksne med skrøpelighet i samfunnet: En randomisert kontrollert prøvelse
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
New Territories
-
Shatin, New Territories, Hong Kong
- The Nethersole School of Nursing, The Chinese University of Hong Kong
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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". |
|
Aktiv komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective well-being
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical functioning
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2023.585.M
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