## Protocol Section
### Identification Module
**NCT ID:** NCT06415617

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

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

#### Organization Study ID Info
**ID:** 2023.585.p
#### Organization
**Class:** OTHER
**Full Name:** Chinese University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2024-04-09

**Type:** ACTUAL

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

**Type:** ACTUAL

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

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-09

**Type:** ACTUAL

#### Start Date
**Date:** 2023-11-24

**Type:** ACTUAL

**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 test the feasibility and acceptability of home-based psychoeducation in older adults with frailty in the community. The main questions it aims to answer are

1. Are the proposed eligibility criteria for participants and the study process in recruiting and retaining the participants appropriate?
2. Is home-based psychoeducation feasible and acceptable for 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 two home visits for data collection. An individual interview will be conducted with participants in the experimental group to explore their experiences.

### 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:** 24

**Type:** ACTUAL

**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" . The participants will be engaged in psychoeducation through group discussion, individualised goal setting and reflective exercises.

**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 feasibility of the study will be measured in terms of participation rate, self-reported intervention adherence, and attrition rate.

**Measure:** Participation rate, self-reported intervention adherence, and attrition rate.

**Time Frame:** 12 weeks post-allocation

**Description:** A 5-item satisfaction survey will be conducted by the end of the intervention for participants to rate the intervention in terms of appropriates of the session content, length of each session, overall intervention duration and delivery mode, from 1 (very dissatisfied) to 5 (very satisfied).

**Measure:** Acceptability

**Time Frame:** 12 weeks post-allocation

#### Secondary Outcomes

**Description:** FRAIL scale

**Measure:** Frailty level

**Time Frame:** 12 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:** 12 weeks post-allocation

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

**Measure:** Activities of daily living

**Time Frame:** 12 weeks post-allocation

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

**Measure:** Instrumental activities of daily living

**Time Frame:** 12 weeks post-allocation

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

**Measure:** Subjective well-being

**Time Frame:** 12 weeks post-allocation

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

**Measure:** Depressive symptoms

**Time Frame:** 12 weeks post-allocation

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

**Measure:** Social support

**Time Frame:** 12 weeks post-allocation

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

**Measure:** Quality of life

**Time Frame:** 12 weeks post-allocation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

(1) aged 65 years or over; (2) meeting frailty criteria by FRAIL scale (score 3 or above) ; (3) mentally competent screened by The Abbreviated Mental Test (AMT≥6) ; (4) able to speak and understand Cantonese; (5) living at home; (6) having experience using a smartphone (e.g.: sending messages, watching videos)

Exclusion Criteria:

(1) have a visual or hearing problem or a language barrier that may affect their communication or understanding; (2) being unfit for home-based exercise, as defined by having one point or above at either the 25-item Home Falls and Accidents self-reported screening tool (HOME-FAST), which is a comprehensive tool for identify home hazards for fall (3) are currently practising exercise for at least 150 minutes per week in previous four weeks; (4) are receiving active psychiatric or antidepressant treatment or joining other physical exercises or rehabilitation programmes

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shatin

**Country:** Hong Kong

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

**State:** New Territories

### 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
