None listed
Conditions
Brief summary
Targeted lifestyle interventions that include education, behaviour change and/or group support components could be effective in improving the lifestyle risk factors, increased falls risk and poorer mental health status associated with age-related macular degeneration (AMD). This study therefore aims to develop, implement and evaluate an online intervention through the Movement, Interaction and Nutrition for Greater Lifestyles in the Elderly (MINGLE) program. This will be achieved over two phases: 1) a small qualitative study (semi-structured interviews) with AMD patients to determine the barriers and facilitators to participating in such a program; and 2) applying the findings from phase 1 to inform the development of the MINGLE program, followed by a pilot study to evaluate its feasibility and acceptability. Participants will be recruited from a private eye clinic in Westmead NSW. Eligible Phase 1 participants will be: 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent in English, 3) verbally consent to participate in the study (including audio recording). Audio recordings will be transcribed verbatim by a transcribing service and analysed and coded iteratively to ensure analytic reflexivity. Key themes will be established relating to barriers and facilitators to participating in MINGLE. Eligible Phase 2 participants will be 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent in English, 3) able to access a smart device with a front-facing camera; 4) technically capable to use Zoom or have someone to help; 4) cleared to safely participate in the physical activity components of the intervention (i.e. Physical Activity Readiness Questionnaire or written physician clearance for participation). Participants also agree to provided written informed consent to participate and complete the baseline questionnaire. For the intervention, participants will be divided into subgroups based on session timings (morning/afternoon). Sessions will run for 60-minutes once/week over ten-weeks with each session including 10 minutes informal socialising; 30 minutes physical activity session; 15 minutes nutrition education. Descriptive statistics will be used to assess the acceptability and feasibility of MINGLE. T-tests will be carried out to assess the pre-post intervention improvement in quality of life, falls efficacy, physical activity, and dietary intakes. The baseline questionnaire will be re-administered immediately post-intervention. The primary outcomes of the questionnaire are significant improvements in loneliness. The secondary outcomes are significant improvements in quality of life, attitudes towards the intervention, falls self-efficacy, physical activity level and diet. The primary process outcome of this study is the development of a novel holistic online intervention with a focus on socialisation, physical activity, and nutrition education to specifically improve the wellbeing of people with AMD.
Interventions
Phase 1 of this study includes once-off, audio-recorded semi-structured interviews with AMD patients recruited from a private eye clinic in Western Sydney, Australia. These interviews are estimated to take an average of 20 minutes and will help to identify the barriers and facilitators to participating in MINGLE and inform any modifications to the program prior to Phase 2 of the study. These interviews will be administered by a member of the research team either face-to-face or via telephone, de
Phase 1 of this study includes once-off, audio-recorded semi-structured interviews with AMD patients recruited from a private eye clinic in Western Sydney, Australia. These interviews are estimated to take an average of 20 minutes and will help to identify the barriers and facilitators to participating in MINGLE and inform any modifications to the program prior to Phase 2 of the study. These interviews will be administered by a member of the research team either face-to-face or via telephone, depending on the participant's preference and the general health recommendations during the global pandemic. Phase 2 of this study is the online intervention, which will be administered via Zoom. It will commence after the preliminary analysis of Phase 1 data. Participants for Phase 2 will be recruited from the same private eye clinic as described in Phase 1. Participants of Phase 1 will also be given the opportunity to participate in Phase 2 if they are interested. A draft form of the program will involve the following: Participants will be divided into subgroups based on session timings (morning/afternoon). Sessions will run for 60-minutes once/week over ten-weeks. Sessions will be structured as follows: 10 minutes informal socialising; 30 minutes physical activity session; 15 minutes nutrition education. The physical activity session will not require any equipment other than a chair and will be facilitated by the research assistant (with an exercise-related qualification) and a research student who will be enrolled in a medical/allied health degree. Each physical activity session will be the same and proposed to include: 5-minute mindful breathing, 15-minute warm-up and moderate intensity exercises (e.g. stretching and bodyweight strengthening exercises), and 10-minute cool down (e.g. balance exercises and stretching). Participants will be given a short break to use the facilities and drink water before commencing the 15-minute nutrition education session with a focus on evidence-based topics. These topics include evidence-based nutritional supplements - what's out there and what's recommended; key nutrients for eye health e.g., lutein and zeaxanthin; the Australian Dietary Guidelines - core food groups and serving sizes. The format of nutrition education will vary and range from presentations by the research assistant and/or student to interactive activity and/or discussion. Adherence to the intervention will be assessed by systematically tracking all participant contacts to allow for reporting on: the number sessions attended, completed sessions (‘dose’ of intervention received), and reasons for missed sessions. The session content will be tracked via checklists completed after each session allowing for reporting on the extent to which the intervention content is delivered per protocol and percentage of participants engaging/completing the activities.
Sponsors
Macquarie University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1 (semi-structured interviews) eligibility: 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent English, 3) consent to participate in the study (including audio recording). Phase 2 (pilot study) eligibility: 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent English, 3) access to a smart phone, tablet or laptop with a front-facing camera; 4) technical ability to use Zoom or have someone to help; 4) clearance to safely participate in the physical activity components of the intervention (i.e. Physical Activity Readiness Questionnaire (PARQ+) or written physician clearance for participation; 5) written informed consent to participate.
Exclusion criteria
Phase 2 exclusion criteria: 1) unable to ambulate/walk for exercise; 2) serious illness limiting their ability to exercise or complete the trial; 3) contraindications to exercise (i.e. failure to fulfil the prerequisites of the PARQ+); 4) uncontrolled hypertension (>=160/>90 mmHg); 5) signs or symptoms of alcohol/substance abuse and; 6) unable to commit to attending at least 80% of the sessions.
Outcome results
None listed