Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their… (NCT04583748) | Clinical Trial Compass
WithdrawnNot Applicable
Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
Stopped: COVID 19
0Started 2022-04
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients diagnosed with irreversible age-related vision loss (IARVL) by an experienced ophthalmologist and/or their caregivers.
✓. IARVL patients between the age range of 60 to 85 years, while caregivers between the age range of 18 to 85 years.
✓. Be able to provide valid informed consent to participate in the research study.
✓. Being able to speak as well as understand English without the requirement for interpretation or other communication assistance.
✓. Having no significant self-reported or a physician-diagnosed mental health disorder other than depressive and/or anxiety symptoms.
✓. 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).
✓. Have sufficient hearing to be able to follow verbal instructions
✓. Have the ability to sit independently without physical discomfort for 30 minutes.
Exclusion criteria
✕. Inability to provide a valid informed consent.
✕. Having an underlying major neurocognitive disorder as suggested by a Montreal Cognitive Assessment (MoCA) score \< 21.
✕. Having significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
What they're measuring
1
Number of Potential Participants Approached Per Month
Timeframe: 1 year
2
Number of Participants who are Successfully Screened
Timeframe: 1 year
3
Proportion of Successfully Screened in Participants who Enroll
Timeframe: 1 year
4
Rate of Retention
Timeframe: 1 year
5
Rate of Adherence to Study Protocol
Timeframe: 1 year
6
Proportion of Planned Ratings that are Completed
Timeframe: 1 year
7
Intervention Cost Per Case
Timeframe: 1 year
8
Percentage of Time Trade-Off (TTO) Questionnaires Completed
Timeframe: 1 year
9
Percentage of Visual Function Index (VF-14) Questionnaires Completed
Trial details
NCT IDNCT04583748
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
✕. Having severe depression as confirmed by a CES-D ≥ 24.
✕. Participating in other similar studies.
✕. 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).
✕. Self-reported substance abuse or dependence within the past 3 months.
✕. Having an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
Timeframe: 1 year
10
Percentage of Center for Epidemiologic Studies - Depression (CES-D) Questionnaires Completed
Timeframe: 1 year
11
Percentage of Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Questionnaires Completed
Timeframe: 1 year
12
Percentage of Pittsburgh Sleep Quality Index (PSQI) Questionnaires Completed
Timeframe: 1 year
13
Percentage of Community Integration Questionnaire (CIQ) Questionnaires Completed
Timeframe: 1 year
14
Percentage of Connor-Davidson Resilience Scale (CD-RISC) Questionnaires Completed
Timeframe: 1 year
15
Percentage of Zarit Burden Interview (ZBI) Questionnaires Completed