Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of Potential Participants Approached Per Month
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will be blinded to the treatment hypothesis, while investigators and treating clinicians will be additionally blinded to the intervention.
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
- 是
入选标准
- •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.
- •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.
- •Willing to dedicate 20 minutes twice per day six days per week to their assigned home practice.
排除标准
- •Inability to provide a valid informed consent.
- •Having an underlying major neurocognitive disorder as suggested by a Montreal Cognitive Assessment (MoCA) score <
- •Having significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
- •Having severe depression as confirmed by a CES-D ≥
- •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.
- •Having 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.
结局指标
主要结局
Number of Potential Participants Approached Per Month
时间窗: 1 year
The number of potential participants approached per month will be calculated as a feasibility measure.
Rate of Adherence to Study Protocol
时间窗: 1 year
At the end of the study any deviations from the protocol will be examined to determine the rate of adherence to the study protocol. This information will be calculated as a feasibility measure.
Percentage of Center for Epidemiologic Studies - Depression (CES-D) Questionnaires Completed
时间窗: 1 year
The percentage of CES-D questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Intervention Cost Per Case
时间窗: 1 year
The cost per participant of attending the SSM program will be calculated as a feasibility measure.
Proportion of Successfully Screened in Participants who Enroll
时间窗: 1 year
The proportion of successfully screened in participants who enroll in the study will be calculated as a feasibility measure.
Number of Participants who are Successfully Screened
时间窗: 1 year
The number of participants who are successfully screened will be calculated as a feasibility measure.
Rate of Retention
时间窗: 1 year
The rate of retention of participants in the study will be calculated as a feasibility measure.
Percentage of Time Trade-Off (TTO) Questionnaires Completed
时间窗: 1 year
The percentage of TTO questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Visual Function Index (VF-14) Questionnaires Completed
时间窗: 1 year
The percentage of VF-14 questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Questionnaires Completed
时间窗: 1 year
The percentage of HADS-A questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Proportion of Planned Ratings that are Completed
时间窗: 1 year
The proportion of completed planned ratings will be calculated as a feasibility measure.
Percentage of Pittsburgh Sleep Quality Index (PSQI) Questionnaires Completed
时间窗: 1 year
The percentage of PSQI questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Community Integration Questionnaire (CIQ) Questionnaires Completed
时间窗: 1 year
The percentage of CIQ questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Connor-Davidson Resilience Scale (CD-RISC) Questionnaires Completed
时间窗: 1 year
The percentage of CD-RISC questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Zarit Burden Interview (ZBI) Questionnaires Completed
时间窗: 1 year
The percentage of ZBI questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
次要结局
- Change in Health-Related Quality of Life Score(Weeks 0 and 12)
- Change in Vision-Related Quality of Life Score(Weeks 0 and 12)
- Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)(Weeks 0 and 12)
- Change in Community Integration(Weeks 0 and 12)
- Change in Caregiver Burden(Weeks 0 and 12)
- Change in Depressive Symptoms(Weeks 0 and 12)
- Change in Anxiety Symptoms(Weeks 0 and 12)
- Change in Resilience(Weeks 0 and 12)
研究者
Akshya Vasudev
Consultant Geriatric Psychiatrist
Lawson Health Research Institute