## Protocol Section
### Identification Module
**NCT ID:** NCT06415604

**Brief Title:** Home-based Psychoeducation for Older Adults With Frailty: A Randomised Controlled Trial

**Official Title:** Effects of a Home-based Psychoeducation on Subjective Well-being for Older Adults With Frailty in the Community: A Randomised Controlled Trial

#### Organization Study ID Info
**ID:** 2023.585.M
#### Organization
**Class:** OTHER
**Full Name:** Chinese University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** TAO An

#### Responsible Party

**Investigator Affiliation:** Chinese University of Hong Kong

**Investigator Full Name:** TAO An

**Investigator Title:** Mr

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Frailty

- Well-Being, Psychological

**Keywords:**

- Subjective well-being

- frailty

- psychoeducation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 138

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive 60-minute weekly online group-based psychoeducation sessions for 12 weeks.

**Intervention Names:**

- Other: Psychoeducation

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive 60-minute weekly online group-based physical health sessions for 12 weeks.

**Intervention Names:**

- Other: Attention control

**Label:** Control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

**Description:** The content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving".

**Name:** Psychoeducation

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** The content of the sessions mainly focuses on physical health information, such as healthy eating, physical exercise, prevention of falls, and pain management.

**Name:** Attention control

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The Chinese 5-item World Health Organization Well-Being Index

**Measure:** Subjective well-being

**Time Frame:** baseline, 12 weeks post-allocation, 24 weeks post-allocation

#### Secondary Outcomes

**Description:** FRAIL scale

**Measure:** Frailty level

**Time Frame:** baseline, 12 weeks post-allocation, 24 weeks post-allocation

**Description:** The Senior Fitness Test: It covers four dimensions, including muscle endurance, balance, flexibility, and tolerance measured by 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

**Measure:** Physical functioning

**Time Frame:** baseline, 12 weeks post-allocation, 24 weeks post-allocation

**Description:** Katz Index of Independence in Activities of Daily Living

**Measure:** Activities of daily living

**Time Frame:** baseline, 12 weeks post-allocation, 24 weeks post-allocation

**Description:** Lawton Instrumental Activities of Daily Living Scale

**Measure:** Instrumental activities of daily living

**Time Frame:** baseline, 12 weeks post-allocation, 24 weeks post-allocation

**Description:** 4-item Geriatric Depression scale

**Measure:** Depressive symptoms

**Time Frame:** baseline, 12 weeks post-allocation, 24 weeks post-allocation

**Description:** 10-item Duke Social Support Index

**Measure:** Social support

**Time Frame:** baseline, 12 weeks post-allocation, 24 weeks post-allocation

**Description:** EuroQol 5-Dimension 5-Level

**Measure:** Quality of life

**Time Frame:** baseline, 12 weeks post-allocation, 24 weeks post-allocation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

(1) Aged 65 or older; (2) Identified as frail by the FRAIL scale (score ≥3); (3) Mentally competent as determined by the Abbreviated Mental Test (AMT ≥6); (4) Able to speak and understand Cantonese; (5) Living at home; (6) Experienced in using a smartphone (e.g., sending messages, watching videos).

Exclusion Criteria:

(1) Have visual or hearing impairments or language barriers that may impact communication or understanding; (2) Unfit for home-based exercise, as indicated by a score of 1 or higher on the 25-item HOME-FAST, a tool for identifying home fall hazards; (3) Currently engaging in exercise for at least 150 minutes per week over the past four weeks; (4) Undergoing active psychiatric or antidepressant treatment or participating in other physical exercise or rehabilitation programs.

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** andersontao@link.cuhk.edu.hk

**Name:** An TAO

**Phone:** (852) 39439929

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shatin

**Contacts:**

***Contact 1:***

- **Email:** andersontao@link.cuhk.edu.hk

- **Name:** An TAO

- **Phone:** (+852) 39439929

- **Role:** CONTACT

**Country:** Hong Kong

**Facility:** The Nethersole School of Nursing, The Chinese University of Hong Kong

**State:** New Territories

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M1175

- Name: Frailty

- Relevance: HIGH

- As Found: Frailty

### Condition Browse Module - Meshes

- ID: D000073496

- Term: Frailty

### Misc Info Module

- Version Holder: 2024-05-31
