Mind and Body: A Clinical Trial Evaluation of a Smartphone App-based Mindfulness Intervention to Support Psychosocial Resilience in Aging Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Outcome: Cost of treatment; Measure: Duration of stay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over the age of
- •Admitted as In-Patients.
- •Access to a smart phone with data connection.
- •Willing to give time for mindfulness practice.
- •Sufficient ability to speak and read English.
- •Willingness to be randomized into immediate or waitlist groups and complete all assessments.
排除标准
- •Any cognitive or mental impairment that would interfere with completing questionnaires or the intervention (<6 on the Brief Screen for Cognitive Impairment) .
- •Admitted to Providence as an in-patient to long-term care or palliative care.
- •An existing smartphone app-based mindfulness practice consisting of one or more sessions per week.
结局指标
主要结局
Outcome: Cost of treatment; Measure: Duration of stay
时间窗: 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: * Date of admission. * Date of discharge.
Outcome: Cost of treatment; Measure: National Rehabilitation Reporting System (NRS) assessments.
时间窗: 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. 1. - Total assistance with helper 2. - Maximal assistance with helper 3. - Moderate assistance with helper 4. - Minimal assistance with helper 5. - Supervision or setup with helper 6. - Modified independence with no helper 7. - Complete independence with no helper
Outcome: Cost of treatment; Measure: number of clinic visits
时间窗: 6 months
Post six-month retrospective report of patients' clinic visits.
Outcome: Health services utilization; measure: survey questions
时间窗: 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). 1. Compared to the 3 months prior to the study, in the past 3 months my use of health care services has: (1) greatly decreased (2) stayed the same (3) greatly increased 2. How many times did you visit your doctor's office visits in the last 3 months? 3. How many times a caregiver visit you in your home in the last 3 months? 4. How many times were you admitted to a hospital in the last 3 months.
Outcome: Cost of treatment; Measure: Discharge destination
时间窗: 6 months
Indicates whether the patient returns home, or is discharged to another care facility (e.g., long term or palliative care).
Outcome: Cost of treatment; Measure: Alternate Level of Care (ALC) assignment.
时间窗: 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
Outcome: Cost of treatment; Measure: Rehabilitation Patient Group (RPG)
时间窗: 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.
次要结局
- Outcome: clinician reported quality of patient appointment time; measure: purpose designed survey questions(1 month)
- Outcome: User engagement; Measure: The Am app's user analytics - meditation choice and frequency(6 months)
- Outcome: Mood, stress and heart rate; Measure: The Am app's biometric measures (Heart Rate)(6 months)
- Outcome: Stress; Measure: The Am app's stress measure(6 months)
- Outcome: Stress; Measure: The Am app's intent for practicing mindfulness measure(6 months)
- Outcome: stress; Measure: NIH Toolbox Perceived Stress Fixed Form (Age 18+ v2.0)(6 months)
- Outcome: Mood; Measure: The Am app's mood measure(6 months)
- Outcome: Psychological flexibility; Measure: The Acceptance & Action Questionnaire-II(6 months)
- Outcome: Mood, stress and heart rate; Measure: The Am app's biometric measures (relative blood oxygen saturation)(6 months)
- Outcome: Mood, stress and heart rate; Measure: The Am app's biometric measures (respiratory rate)(6 months)
- Outcome: User engagement; Measure: The Am app's points structure(6 months)
- Outcome: Impact on health-related quality of life; Measure: PROMIS57(6 months)
研究者
Rachel Devitt
Professional Practice Leader, Occupational Therapy and Manager, Clinical Research at Providence Healthcare
Providence Healthcare