St. Joseph's Hospital, Ivey Eye Institute
London, Ontario, N6G0H8, Canada
NCT Number: NCT03166072
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
London, Ontario, N6G0H8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This therapy will be delivered using the hospital approved Microsoft TEAMS platform by trained, certified non-clinician teachers. 25 irreversible age-related vision loss patients and their 25 caregivers in the MEDITATION arm will be trained for 2 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will learn how to respond to experiences that arise in meditation, will discuss what enhances or detracts from effective meditation, and review methods for meditating at home. Weekly reinforcement sessions will include 33 minutes of guided meditation practice, and then focus on participants' experiences with meditation during the week, additional observations, and a review of relevant knowledge to support their home practice. Each of these follow-up sessions will include a 33-minute guided meditation session. Participants will also be encouraged to practice daily at home for 33 minutes per session.
HEP was designed and used as a manualized active control in meditation-based intervention trials. We have tailored HEP to be structurally equivalent to MEDITATION intervention, with similar-sized groups, meeting for 2 days for 2 hours, and then one 60-75-minute follow up session weekly for the subsequent 11 follow ups. Participants allocated to HEP will be completing the same amount of home practice as MEDITATION, and will be asked to complete weekly practice logs. 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. In HEP, which is provided according to specific guidelines for administration, participants get the support of a group and facilitator, and talk through and try to implement positive health-enhancing life changes.
Time frame: Through study completion, an average of 1 year
Number of participants screened
Time frame: Through study completion, an average of 1 year
Proportion of patients and caregivers who enrol in the study after screening
Time frame: Up to 12 weeks.
Rate of participation retention in the study
Time frame: Up to 12 weeks
Rate of adherence to study protocol
Time frame: Up to 12 weeks
Proportion of planned ratings that are completed and duration of assessment visits
Time frame: Up to 12 weeks
Intervention cost per case
Time frame: Up to 12 weeks
Completeness and quality of final data for analysis
Time frame: Up to 12 weeks
Improvement in HRQOL score as measured by the Short Form 12 Health Survey (SF-12) up to 12 weeks.
Time frame: Through study completion, an average of 1 year
Number of potential participants (IARVL patients and their caregivers) approached per month
Time frame: Up to 12 weeks
Improvement in VRQOL score as measured by the Visual Function 14-item questionnaire (VF-14) up to 12 weeks.
Time frame: Up to 12 weeks
Reduction in depressive symptoms as measured by the Center for Epidemiological Studies Depression questionnaire (CES-D) scores up to 12 weeks.
Time frame: Up to 12 weeks
Reduction in anxiety symptoms as measured by the Hospital Anxiety Scale questionnaire (HADS-A) scores up to 12 weeks.
Time frame: Up to 12 weeks
Enhanced sleep quality as measured by reduction in Pittsburg Sleep Quality Index questionnaire (PSQI) scores (≤ 5) up to 12 weeks.
Time frame: Up to 12 weeks
Enhanced community integration as measured by an increase in Community Integration Questionnaire (CIQ) scores up to 12 weeks.
Time frame: Up to 12 weeks
Reduced caregiver burden as measured by reduction in Zarit Burden Interview (ZBI) scores up to 12 weeks.
Contact information is provided by the study sponsor or research team.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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