Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Participants screened
研究概览
简要总结
Investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation and a Health Enhancement Program, for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers.
详细描述
Using a mixed-method design, a pilot randomized controlled trial (RCT) study, investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation to Remove Stress and Create Proper System in Mind (MEDITATION) and a Health Enhancement Program (HEP) for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers. MEDITATION is a standardized, manualized therapy where participants will be guided by an instructor on meditation techniques, followed by weekly reinforcement sessions. HEP is a similarly structured intervention that controls for several factors experienced in the MEDITATION group, such as group support and morale, behavioral activation, reduction of stigma, facilitator attention, treatment duration, and time spent on at-home practice. Participants will learn about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise, but will not learn breathing techniques, or meditation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with irreversible age-related vision loss (IARVL) and have ongoing significant disability and/or their caregivers who agree to consent.
- •IARVL patients between age 60 to 85 years or caregivers between 18 to 85 years.
- •Deemed competent to provide individual consent to participate.
- •Speak and understand English without requirement for interpretation or assistance.
- •Have no significant self-reported or physician diagnosed mental health disorder other than depressive and/or anxiety symptoms.
- •Have either a minimum of CES-D 20-item scale score of 16 OR a minimum of 8 on the Hospital Anxiety Scale (HADS-A) 7-item sub-scale.
- •Have sufficient hearing to be able to follow verbal instructions
- •Ability to sit independently without physical discomfort for 30 minutes.
- •Willing and able to attend, via Microsoft TEAMS software, the four initial training sessions of MEDITATION or HEP and at least 6 follow-up sessions.
- •Willing to dedicate 33 minutes per day to their assigned home practice.
排除标准
- •Inability to provide informed consent.
- •Dementia as defined by MoCA <
- •Have significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
- •Have severe depression CES-D ≥
- •Participating in other similar studies.
- •Have a lifetime diagnosis of self-reported other 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.
- •Have an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
- •Have a terminal medical diagnosis with prognosis of less than 12 months.
- •Having any planned changes to mood-altering medications at the time of enrollment for the next 12 weeks.
研究组 & 干预措施
Meditation
Participants randomized to this arm will undergo the MEDITATION intervention, with weekly training and reinforcement sessions.
干预措施: Meditation (Other)
Treatment as Usual
Participants randomized to this arm will continue to undergo the usual standard of care. The usual standard of care for IARVL patients includes no active treatment since eye surgeons have done all that could possibly be done to restore vision.
Health Enhancement Program (HEP)
Participants randomized to this arm will undergo the Health Enhancement Program (HEP) intervention, with weekly sessions identical in structure to those of the MEDITATION arm.
干预措施: Health Enhancement Program (Other)
结局指标
主要结局
Participants screened
时间窗: Through study completion, an average of 1 year
Number of participants screened
Participants enrolled
时间窗: Through study completion, an average of 1 year
Proportion of patients and caregivers who enrol in the study after screening
Retention rate
时间窗: Up to 12 weeks.
Rate of participation retention in the study
Adherence rate
时间窗: Up to 12 weeks
Rate of adherence to study protocol
Assessment rating and duration
时间窗: Up to 12 weeks
Proportion of planned ratings that are completed and duration of assessment visits
Intervention cost
时间窗: Up to 12 weeks
Intervention cost per case
Data quality
时间窗: Up to 12 weeks
Completeness and quality of final data for analysis
次要结局
- Change in health-related quality of life (HRQOL)(Up to 12 weeks)
- Number of participants approached(Through study completion, an average of 1 year)
- Change in vision-related quality of life (VRQOL)(Up to 12 weeks)
- Change in depression score(Up to 12 weeks)
- Change in anxiety score(Up to 12 weeks)
- Change in sleep quality(Up to 12 weeks)
- Change in community integration(Up to 12 weeks)
- Change in caregiver burden(Up to 12 weeks)
研究者
Monali Malvankar
Assistant Professor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's