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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meditation | Active Comparator | Participants randomized to this arm will undergo the MEDITATION intervention, with weekly training and reinforcement sessions. |
|
| Treatment as Usual | No Intervention | 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) | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants screened | Number of participants screened | Through study completion, an average of 1 year |
| Participants enrolled | Proportion of patients and caregivers who enrol in the study after screening | Through study completion, an average of 1 year |
| Retention rate | Rate of participation retention in the study | Up to 12 weeks. |
| Adherence rate | Rate of adherence to study protocol | Up to 12 weeks |
| Assessment rating and duration | Proportion of planned ratings that are completed and duration of assessment visits | Up to 12 weeks |
| Intervention cost | Intervention cost per case | Up to 12 weeks |
| Data quality | Completeness and quality of final data for analysis | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health-related quality of life (HRQOL) | Improvement in HRQOL score as measured by the Short Form 12 Health Survey (SF-12) up to 12 weeks. | Up to 12 weeks |
| Number of participants approached |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monali Malvankar, PhD | Contact | 5196858500 | 61288 | monali.malvankar@sjhc.london.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Monali Malvankar | Western University, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital, Ivey Eye Institute | London | Ontario | N6G0H8 | Canada |
IPD will not be available to other researchers since the current research team has the necessary expertise to conduct data analysis.
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| Health Enhancement Program | Other | 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. |
|
Number of potential participants (IARVL patients and their caregivers) approached per month
| Through study completion, an average of 1 year |
| Change in vision-related quality of life (VRQOL) | Improvement in VRQOL score as measured by the Visual Function 14-item questionnaire (VF-14) up to 12 weeks. | Up to 12 weeks |
| Change in depression score | Reduction in depressive symptoms as measured by the Center for Epidemiological Studies Depression questionnaire (CES-D) scores up to 12 weeks. | Up to 12 weeks |
| Change in anxiety score | Reduction in anxiety symptoms as measured by the Hospital Anxiety Scale questionnaire (HADS-A) scores up to 12 weeks. | Up to 12 weeks |
| Change in sleep quality | Enhanced sleep quality as measured by reduction in Pittsburg Sleep Quality Index questionnaire (PSQI) scores (≤ 5) up to 12 weeks. | Up to 12 weeks |
| Change in community integration | Enhanced community integration as measured by an increase in Community Integration Questionnaire (CIQ) scores up to 12 weeks. | Up to 12 weeks |
| Change in caregiver burden | Reduced caregiver burden as measured by reduction in Zarit Burden Interview (ZBI) scores up to 12 weeks. | Up to 12 weeks |
| ID | Term |
|---|---|
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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