Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Inability to provide informed consent.

Dementia as defined by MoCA < 21.

Have significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).

Have severe depression CES-D ≥ 24.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Meditation

    Other intervention

    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.

  • Health Enhancement Program

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: MeditationActive comparator 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions
Group C: Health Enhancement Program (HEP)Other 1 intervention

Trial outcomes

Primary outcomes

1

Participants screened

Number of participants screened

Time frame
Through study completion, an average of 1 year
2

Participants enrolled

Proportion of patients and caregivers who enrol in the study after screening

Time frame
Through study completion, an average of 1 year
3

Retention rate

Rate of participation retention in the study

Time frame
Up to 12 weeks.
4

Adherence rate

Rate of adherence to study protocol

Time frame
Up to 12 weeks

Secondary outcomes

1

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.

Time frame
Up to 12 weeks
2

Number of participants approached

Number of potential participants (IARVL patients and their caregivers) approached per month

Time frame
Through study completion, an average of 1 year
3

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.

Time frame
Up to 12 weeks
4

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.

Time frame
Up to 12 weeks

Other outcomes

Sponsors and contacts

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