Clinical trial NCT06095037: Mindful Yoga for Older Adults and Caregivers
Official title: Examining the Effectiveness of Mindful Yoga in Enhancing Psychological Well-being Among Older Adults Discharged From Hospital and Their Caregivers: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychological
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 668
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: The Depression, Anxiety, and Stress Scale
timeFrame: Through study completion, an average of 12 weeks
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire
timeFrame: Through study completion, an average of 12 weeks
measure: Five Facet Mindfulness Questionnaire
timeFrame: 3 months follow-up
measure: Five Facet Mindfulness Questionnaire
timeFrame: 6 months follow-up
measure: The meaning in life scale
timeFrame: Through study completion, an average of 12 weeks
measure: The meaning in life scale
timeFrame: 3 months follow-up
measure: The meaning in life scale
timeFrame: 6 months follow-up
measure: The Depression, Anxiety, and Stress Scale
timeFrame: 3 months follow-up
measure: The Depression, Anxiety, and Stress Scale
timeFrame: 6 months follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: Lingnan University
name: Qi Wang
role: PRINCIPAL_INVESTIGATOR
References: