Clinical trial NCT04583748: Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
Official title: Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vision; Disorder, Loss
Caregiver Burnout
Quality of Life
Depression
Anxiety
Sleep
Keywords: Irreversible Age-Related Vision Loss
Caregivers
Quality of Life
Mental Health
Depression
Anxiety
Sleep Quality
Community Integration
Resilience
Caregiver Burden
Sahaj Samadhi Meditation
Health Enhancement Program
Virtual
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: The Art of Living Foundation
First posted: 2020-10-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will undergo 1:1:1 randomization to Sahaj Samadhi Meditation or Health Enhancement Program or Treatment as Usual, stratified by gender. Twenty-five irreversible age-related vision loss patients and their 25 caregivers will be assigned, on a rolling basis, in the three groups.
Primary purpose: TREATMENT

Brief summary: Vision loss is common among older adults and leads to an increased risk for depression and difficulties in daily tasks, thus requiring dependence on caregivers. This study will assess the feasibility of providing two virtual interventions, Sahaj Samadhi Meditation (SSM) and Health Enhancement Program (HEP), to supplement care of patients with irreversible age-related vision loss (IARVL) and their caregivers, with the goal of enhancing mental health and quality of life.

Detailed description: Through a high-quality, single-blind, three-arm mixed-method pilot feasibility study using randomized treatment assignment, the study team will assess two new innovative interventions, Sahaj Samadhi Meditation (SSM) and Health Enhancement Program (HEP), both delivered virtually, to augment clinical care of patients with irreversible age-related vision loss (IARVL), with the goal of enhancing mental health and quality of life (QOL) for patients and/or their caregivers. Participants will be blinded to the treatment hypothesis, while investigators and treating clinicians will be additionally blinded to the intervention. Both SSM and HEP will be taught over 4 consecutive days in similar sized groups (10 patients and/or their 10 caregivers) followed by weekly reinforcement sessions for subsequent 11 weeks. Self-rated questionnaires will be used to collect data on quality of life and mental health symptoms at 0-week and 12-week follow-up

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with irreversible age-related vision loss (IARVL) by an experienced ophthalmologist and/or their caregivers.
2. IARVL patients between the age range of 60 to 85 years, while caregivers between the age range of 18 to 85 years.
3. Be able to provide valid informed consent to participate in the research study.
4. Being able to speak as well as understand English without the requirement for interpretation or other communication assistance.
5. Having no significant self-reported or a physician-diagnosed mental health disorder other than depressive and/or anxiety symptoms.
6. Should reach a minimal threshold of depressive and/or anxiety symptoms as confirmed by either a minimum of Centre for Epidemiologic Studies - Depression (CES-D) 20-item scale score of 16 OR a minimum of 8 on the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A).
7. Have sufficient hearing to be able to follow verbal instructions
8. Have the ability to sit independently without physical discomfort for 30 minutes.
9. Willing and able to attend virtual intervention via Cisco WebEx software, the four initial training sessions of SSM or HEP and at least 6 out of 11 weekly follow-up sessions.
10. Willing to dedicate 20 minutes twice per day six days per week to their assigned home practice.

Exclusion Criteria:

1. Inability to provide a valid informed consent.
2. Having an underlying major neurocognitive disorder as suggested by a Montreal Cognitive Assessment (MoCA) score \< 21.
3. Having significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
4. Having severe depression as confirmed by a CES-D ≥ 24.
5. Participating in other similar studies.
6. Having a lifetime diagnosis of self-reported other serious mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
7. Self-reported substance abuse or dependence within the past 3 months.
8. Having an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
9. Having a terminal medical diagnosis with prognosis of less than 12 months.
10. Having any planned changes to mood-altering medications at the time of enrollment for the next 12 weeks.

Primary outcomes:
measure: Number of Potential Participants Approached Per Month
timeFrame: 1 year
measure: Number of Participants who are Successfully Screened
timeFrame: 1 year
measure: Proportion of Successfully Screened in Participants who Enroll
timeFrame: 1 year
measure: Rate of Retention
timeFrame: 1 year
measure: Rate of Adherence to Study Protocol
timeFrame: 1 year
measure: Proportion of Planned Ratings that are Completed
timeFrame: 1 year
measure: Intervention Cost Per Case
timeFrame: 1 year
measure: Percentage of Time Trade-Off (TTO) Questionnaires Completed
timeFrame: 1 year
measure: Percentage of Visual Function Index (VF-14) Questionnaires Completed
timeFrame: 1 year
measure: Percentage of Center for Epidemiologic Studies - Depression (CES-D) Questionnaires Completed
timeFrame: 1 year
measure: Percentage of Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Questionnaires Completed
timeFrame: 1 year
measure: Percentage of Pittsburgh Sleep Quality Index (PSQI) Questionnaires Completed
timeFrame: 1 year
measure: Percentage of Community Integration Questionnaire (CIQ) Questionnaires Completed
timeFrame: 1 year
measure: Percentage of Connor-Davidson Resilience Scale (CD-RISC) Questionnaires Completed
timeFrame: 1 year
measure: Percentage of Zarit Burden Interview (ZBI) Questionnaires Completed
timeFrame: 1 year
Secondary outcomes:
measure: Change in Health-Related Quality of Life Score
timeFrame: Weeks 0 and 12
measure: Change in Vision-Related Quality of Life Score
timeFrame: Weeks 0 and 12
measure: Change in Depressive Symptoms
timeFrame: Weeks 0 and 12
measure: Change in Anxiety Symptoms
timeFrame: Weeks 0 and 12
measure: Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Weeks 0 and 12
measure: Change in Community Integration
timeFrame: Weeks 0 and 12
measure: Change in Resilience
timeFrame: Weeks 0 and 12
measure: Change in Caregiver Burden
timeFrame: Weeks 0 and 12
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences Centre
name: Akshya Vasudev, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Healthcare London
name: Cindy Hutnik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: