Mindful Yoga for Older Adults and Caregivers | NCT06095037

Studies
Mindful Yoga for Older Adults and Caregivers

NCT06095037

Sponsor

The University of Hong Kong

Status

Not yet recruiting

Last Update Posted

Dec 5, 2024Actual

Enrollment

668Estimated

Phase

Not Applicable

Conditions

Psychological

Interventions

Mindful yoga
Psychoeducation

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Estimated

Primary Completion Date

Mar 1, 2028Estimated

Completion Date

Sep 1, 2028Estimated

First Submitted Date

Oct 12, 2023

First Submission Date that Met QC Criteria

Oct 17, 2023

First Posted Date

Oct 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2024

Last Update Posted Date

Dec 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will adopt the intervention of mindful yoga to improve the psychological well-being of older adults who discharged from hospital and their caregivers in Hong Kong.

Detailed Description

In the proposed study, the investigators will conduct a fully powered, double-blind, and multicentered randomized controlled trial (RCT) of the efficacy of mindful yoga versus a psychoeducation control. The study sample will consist of older adults discharged from hospitals within the previous 3 months and their informal caregivers. The investigators will aim to determine: (1) the efficacy of mindful yoga in the study group versus the control group in improving the dyadic psychological well-being (as measured by depression, anxiety, stress, and meaning of life) of older adult-caregiver dyads (e.g., both actor and partner effects); (2) whether these improvements were maintained after 3 and 6 months; and (3) the lived experiences of older adults and their caregivers. The investigators hypothesize that: (1) mindful yoga will be more efficacious in improving outcomes compared with the control condition; (2) there will be both actor and partner effects of the intervention on the primary and secondary outcomes; and (3) these outcome improvements will be maintained at 3 and 6 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

668Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Mindful yoga	Behavioral: Mindful yoga
Control	Active Comparator	Psychoeducation	Behavioral: Psychoeducation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindful yoga	Behavioral	12 week mindful yoga intervention	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Depression, Anxiety, and Stress Scale	The total score ranges from 0 to 63. Higher score indicates higher level of depression, anxiety and stress	Through study completion, an average of 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Five Facet Mindfulness Questionnaire	The total score ranges from 39 to 195. Highers score indicates higehr level of mindfulness	Through study completion, an average of 12 weeks
Five Facet Mindfulness Questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older adults discharged from hospital

older adults aged 65 years or above;
individuals who have been discharged from a local hospital within the previous 3 months who qualify for the Pilot Scheme on Support for Elderly Persons Discharged from Public Hospitals after Treatment and are receiving services from community support services;
individuals with no mobility issues or who have limited mobility but can access the intervention sites using a wheelchair and are capable of practicing mindful yoga, even if in a wheelchair; and
individuals who can understand Cantonese.

Caregivers:

• living with older adults during the transition period from hospital to home.

Exclusion Criteria:

Older adults discharged from hospital

older adults diagnosed with depression, anxiety, or stress disorders by certified doctors;
older adults diagnosed with severe dementia;
homebound older adults who face difficulty attending the intervention sites; and
older adults having a tech-enabled Hospital Admission Risk Reduction Program for the Elderly (HARRPE) score <0.17 or >0.29.

Caregivers:

• Family caregivers who have been diagnosed with severe mental health issues will be excluded from the proposed study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Qi Wang	Contact	51610558		vickywang@ln.edu.hk
Xiaochen Zhou	Contact	26168617		xczhou@hku.hk

Name	Affiliation	Role
Qi Wang	Lingnan University	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data without participants' privacy information will be shared

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

The supporting documents will be shared June 30, 2024

Access Criteria

Anyone can access to the supporting documents

URL

Not provided