Providence Healthcare
Toronto, Ontario, M1L1W1, Canada
NCT Number: NCT03908918
This study evaluates the use of a mobile-app delivered mindfulness-based intervention for supporting psychosocial resilience in aging patients undergoing rehabilitation treatment. Half of the patients will receive the mobile-app, while the other half will receive the app 6 months later.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M1L1W1, Canada
Although, several mobile-app based MBTs are available in the marketplace, there is scant evidence of high scientific rigor to support their therapeutic efficacy. Furthermore, the tracking of wellness outcomes, stress resilience and functioning as a result of use of a therapeutic digital product is a challenging task requiring expertise in technology. In this study, the investigators aim to investigate not only the effectiveness of an app-based MBT in aging adults, but also the mechanisms of efficacy - i.e. the therapeutic effects - of app usage, including changes in, depression, anxiety, or mood and the acceptance of the app in older adult populations. The investigators also aim to measure the Return On Investment (ROI) of mobile mindfulness on health services utilization.
The study is a randomized controlled design with 1:1 equal allocation to treatment (Experimental Am app group) or control (treatment as usual). The investigators will recruit 82 participants in total.
The Experimental group will start the 4 week Am app intervention immediately after randomization and baseline intervention questionnaires, while the wait-list control group will receive treatment as usual. Assessments are conducted at four time point: At Baseline (#1), Post-Intervention (#2), Follow-up at 3 months post baseline (#3) and Follow-up at 6 months post baseline (#4).
The clinical champions that referred the patient to the study will complete brief surveys about the quality of their appointments with the patient at two time points: At baseline (#1) and Post-Intervention (#2).
The waitlist control group will be granted access to the mindfulness intervention at 6 months post baseline.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mobile app-delivered mindfulness intervention delivered over 4 weeks.
Other names: Am
Time frame: 6 months
To evaluate the cost-benefit measures of the Am smartphone-app by measuring length of stay in hospital and levels of health services utilization
As no Electronic Health Records (EHR) are kept by Providence, a chart review, including progress notes, will be required to assess the following:
Time frame: 6 months
Cost of Treatment will also be measured using patient self-reports of health services utilization at 3 and 6 months post intervention. Participants will answer five questions related to their use of health services utilization drawn from peer-reviewed literature (Van den Brink et al., 2005).
Time frame: 6 months
Indicates whether the patient returns home, or is discharged to another care facility (e.g., long term or palliative care).
Time frame: 6 months
If Alternate Level of Care (ALC) assigned, the reasons underlying the decision. The term ALC is a clinical designation that identifies patients who no longer require the intensity of resources or services provided in their current settings and who are wait
Time frame: 6 months
The NRS minimum data set contains clinical data on functional status based on the 18-item Functional Independence Measure (FIM®) instrument.
FIM™ is comprised of 18 items, grouped into 2 subscales - motor and cognition.
Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.
Time frame: 6 months
The NRS gives an RPG score used to categorize patient data based on their primary reason for receiving inpatient rehabilitation services.
Based on a patient's primary reason for receiving inpatient rehabilitation services, and using client age at admission and motor and cognitive functional status, patient's are assigned to one of 83 RPGs.
Time frame: 6 months
Post six-month retrospective report of patients' clinic visits.
Time frame: 6 months
To evaluate the efficacy of the Am smartphone-app to relieve symptoms of stress
The NIH Toolbox Perceived Stress Fixed Form contains measures in the domains of emotional health and was designed for use in epidemiological and clinical trials health-related research. It was selected for inclusion and subsequent national norming for the NIH Toolbox based on its psychometric performance.
Time frame: 6 months
To evaluate the efficacy of the Am smartphone-app for treating symptoms of anxiety, sleep disturbance, mood disturbance, and overall quality of life
PROMIS57 is a collection of short forms containing a fixed number of items from seven PROMIS domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). There are 8 questions per domain, and an additional pain intensity 0-10 numeric rating scale (NRS). The Profiles are universal rather than disease-specific.
Time frame: 1 month
Survey 1
Survey 2
Time frame: 6 months
Am quantifies the efficacy of mindfulness training on each individual user through self-reports.
Self-reported mood will be collected by the participant's selection of mood words from Mobio's circumplex model of affect (based on Posner, Russell & Peterson, 2005). This model holds that all emotions derive from two underlying, orthogonal dimensions of emotional experience: valence and arousal. These orthogonal dimensions divide the circumplex into four quarters: low arousal - low affect; low arousal - high affect; high arousal - low affect; high arousal - high affect.
Time frame: 6 months
The Acceptance & Action Questionnaire-II (AAQ-II) was developed in order to measure psychological flexibility, and scores have been found to predict many outcomes, including mental health and work absence rates.
The AAQ-II is a seven item, one factor measure of psychological inflexibility or experiential avoidance. The scale is scored by summing the responses. Higher scores equal greater levels of psychological inflexibility.
Time frame: 6 months
The time, date and type of meditation users choose while participating in the study.
Time frame: 6 months
Am quantifies the efficacy of mindfulness training on each individual user through heart rate, an objective assessment of stress made possible through computer vision (biometrics) with the mobile device camera.
Time frame: 6 months
Am quantifies the efficacy of mindfulness training on each individual user through respiratory rate, an objective assessment of stress made possible through computer vision (biometrics) with the mobile device camera.
Time frame: 6 months
Am quantifies the efficacy of mindfulness training on each individual user through relative blood oxygen saturation, an objective assessment of stress made possible through computer vision (biometrics) with the mobile device camera.
Time frame: 6 months
Am quantifies the efficacy of mindfulness training on each individual user through self-reports.
Self-reported stress will be indicated by the participant's adjustment of a dynamic slider between the minimum score "no stress" and the maximum score "max stress" will be collected.
Time frame: 6 months
This will be based on the participants' indication as per their selection of between 1 and 3 "intent words". There are 24 options from which the participant can choose. These are divided into 6 outward intentions, and 18 inward intentions.
Time frame: 6 months
Users are rewarded with in-app points according to a point structure that encourages engagement with the app.
Providence Healthcare
Other
Mind and Body: A Clinical Trial Evaluation of a Smartphone App-based Mindfulness Intervention to Support Psychosocial Resilience in Aging Patients
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