Clinical trial NCT03908918: Mind and Body:A Clinical Trial Evaluation of a Smartphone App-based Mindfulness Intervention
Official title: Mind and Body: A Clinical Trial Evaluation of a Smartphone App-based Mindfulness Intervention to Support Psychosocial Resilience in Aging Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Psychological Distress
Rehabilitation
Lead sponsor: Providence Healthcare
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Men and women over the age of 40.
2. Admitted as In-Patients.
3. Access to a smart phone with data connection.
4. Willing to give time for mindfulness practice.
5. Sufficient ability to speak and read English.
6. Willingness to be randomized into immediate or waitlist groups and complete all assessments.

Exclusion Criteria:

1. Any cognitive or mental impairment that would interfere with completing questionnaires or the intervention (\<6 on the Brief Screen for Cognitive Impairment) .
2. Admitted to Providence as an in-patient to long-term care or palliative care.
3. An existing smartphone app-based mindfulness practice consisting of one or more sessions per week.

Primary outcomes:
measure: Outcome: Cost of treatment; Measure: Duration of stay
timeFrame: 6 months
measure: Outcome: Health services utilization; measure: survey questions
timeFrame: 6 months
measure: Outcome: Cost of treatment; Measure: Discharge destination
timeFrame: 6 months
measure: Outcome: Cost of treatment; Measure: Alternate Level of Care (ALC) assignment.
timeFrame: 6 months
measure: Outcome: Cost of treatment; Measure: National Rehabilitation Reporting System (NRS) assessments.
timeFrame: 6 months
measure: Outcome: Cost of treatment; Measure: Rehabilitation Patient Group (RPG)
timeFrame: 6 months
measure: Outcome: Cost of treatment; Measure: number of clinic visits
timeFrame: 6 months
Secondary outcomes:
measure: Outcome: stress; Measure: NIH Toolbox Perceived Stress Fixed Form (Age 18+ v2.0)
timeFrame: 6 months
measure: Outcome: Impact on health-related quality of life; Measure: PROMIS57
timeFrame: 6 months
measure: Outcome: clinician reported quality of patient appointment time; measure: purpose designed survey questions
timeFrame: 1 month
measure: Outcome: Mood; Measure: The Am app's mood measure
timeFrame: 6 months
measure: Outcome: Psychological flexibility; Measure: The Acceptance & Action Questionnaire-II
timeFrame: 6 months
measure: Outcome: User engagement; Measure: The Am app's user analytics - meditation choice and frequency
timeFrame: 6 months
measure: Outcome: Mood, stress and heart rate; Measure: The Am app's biometric measures (Heart Rate)
timeFrame: 6 months
measure: Outcome: Mood, stress and heart rate; Measure: The Am app's biometric measures (respiratory rate)
timeFrame: 6 months
measure: Outcome: Mood, stress and heart rate; Measure: The Am app's biometric measures (relative blood oxygen saturation)
timeFrame: 6 months
measure: Outcome: Stress; Measure: The Am app's stress measure
timeFrame: 6 months
measure: Outcome: Stress; Measure: The Am app's intent for practicing mindfulness measure
timeFrame: 6 months
measure: Outcome: User engagement; Measure: The Am app's points structure
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Providence Healthcare
state: Ontario
Study officials:
affiliation: Providence Healthcare
name: Rachel Devitt
role: PRINCIPAL_INVESTIGATOR
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