Mind and Body:A Clinical Trial Evaluation of a Smartphone App-based Mindfulness Intervention

NCT03908918 | Completed

• 1 other identifier: 123
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Stress; Psychological Distress; Rehabilitation

Outcome Measures

Primary Outcomes (7)

• Outcome: Cost of treatment; Measure: Duration of stay

  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.

  6 months

• Outcome: Health services utilization; measure: survey questions

  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.

  6 months

• Outcome: Cost of treatment; Measure: Discharge destination

  Indicates whether the patient returns home, or is discharged to another care facility (e.g., long term or palliative care).

  6 months

• Outcome: Cost of treatment; Measure: Alternate Level of Care (ALC) assignment.

  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

  6 months

• Outcome: Cost of treatment; Measure: National Rehabilitation Reporting System (NRS) assessments.

  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

  6 months

• Outcome: Cost of treatment; Measure: Rehabilitation Patient Group (RPG)

  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.

  6 months

• Outcome: Cost of treatment; Measure: number of clinic visits

  Post six-month retrospective report of patients' clinic visits.

  6 months

Secondary Outcomes (12)

• Outcome: stress; Measure: NIH Toolbox Perceived Stress Fixed Form (Age 18+ v2.0)

  6 months

• Outcome: Impact on health-related quality of life; Measure: PROMIS57

  6 months

• Outcome: clinician reported quality of patient appointment time; measure: purpose designed survey questions

  1 month

• Outcome: Mood; Measure: The Am app's mood measure

  6 months

• Outcome: Psychological flexibility; Measure: The Acceptance & Action Questionnaire-II

  6 months

Study Arms (2)

Active group

EXPERIMENTAL

Mobile-app delivered mindfulness intervention. Dosage: 4 times per week for 4 weeks

Other: Mindfulness app

Waitlist control

OTHER

Waitlist control - receiving the app after 6 months

Other: Mindfulness app

Interventions

Mindfulness app OTHER

Mobile app-delivered mindfulness intervention delivered over 4 weeks.

Also known as: Am

Active group; Waitlist control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over the age of 40.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Providence Healthcare: lead

Study Sites (1)

Providence Healthcare

Toronto, Ontario, M1L1W1, Canada

Location

Related Publications (12)

• Sachs-Ericsson N, Van Orden K, Zarit S. Suicide and aging: special issue of Aging & Mental Health. Aging Ment Health. 2016;20(2):110-2. doi: 10.1080/13607863.2015.1099037. Epub 2015 Nov 7. No abstract available.

  PMID: 26548754 BACKGROUND

• Schulze T, Maercker A, Horn AB. Mental health and multimorbidity: psychosocial adjustment as an important process for quality of life. Gerontology. 2014;60(3):249-54. doi: 10.1159/000358559. Epub 2014 Feb 28.

  PMID: 24603025 BACKGROUND

• Rao KS, Chakraharti SK, Dongare VS, Chetana K, Ramirez CM, Koka PS, Deb KD. Antiaging Effects of an Intensive Mind and Body Therapeutic Program through Enhancement of Telomerase Activity and Adult Stem Cell Counts. J Stem Cells. 2015;10(2):107-25.

  PMID: 27125139 BACKGROUND

• Scult M, Haime V, Jacquart J, Takahashi J, Moscowitz B, Webster A, Denninger JW, Mehta DH. A healthy aging program for older adults: effects on self-efficacy and morale. Adv Mind Body Med. 2015 Winter;29(1):26-33.

  PMID: 25607120 BACKGROUND

• de Frias CM, Whyne E. Stress on health-related quality of life in older adults: the protective nature of mindfulness. Aging Ment Health. 2015;19(3):201-6. doi: 10.1080/13607863.2014.924090. Epub 2014 Jun 18.

  PMID: 24940847 BACKGROUND

• Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.

  PMID: 24395196 BACKGROUND

• Charness N, Best R, Evans J. Supportive home health care technology for older adults: Attitudes and implementation. Gerontechnology. 2016 Feb 23;15(4):233-242. doi: 10.4017/gt.2016.15.4.006.00.

  PMID: 29033700 BACKGROUND

• Deng Z, Mo X, Liu S. Comparison of the middle-aged and older users' adoption of mobile health services in China. Int J Med Inform. 2014 Mar;83(3):210-24. doi: 10.1016/j.ijmedinf.2013.12.002. Epub 2013 Dec 16.

  PMID: 24388129 BACKGROUND

• Nguyen T, Irizarry C, Garrett R, Downing A. Access to mobile communications by older people. Australas J Ageing. 2015 Jun;34(2):E7-E12. doi: 10.1111/ajag.12149. Epub 2014 Apr 17.

  PMID: 24750499 BACKGROUND

• Walsh KM, Saab BJ, Farb NA. Effects of a Mindfulness Meditation App on Subjective Well-Being: Active Randomized Controlled Trial and Experience Sampling Study. JMIR Ment Health. 2019 Jan 8;6(1):e10844. doi: 10.2196/10844.

  PMID: 30622094 BACKGROUND

• Hill J, McVay JM, Walter-Ginzburg A, Mills CS, Lewis J, Lewis BE, Fillit H. Validation of a brief screen for cognitive impairment (BSCI) administered by telephone for use in the medicare population. Dis Manag. 2005 Aug;8(4):223-34. doi: 10.1089/dis.2005.8.223.

  PMID: 16117717 BACKGROUND

• van den Brink M, van den Hout WB, Stiggelbout AM, Putter H, van de Velde CJ, Kievit J. Self-reports of health-care utilization: diary or questionnaire? Int J Technol Assess Health Care. 2005 Summer;21(3):298-304. doi: 10.1017/s0266462305050397.

  PMID: 16110708 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Rachel Devitt

  Providence Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professional Practice Leader, Occupational Therapy and Manager, Clinical Research at Providence Healthcare

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: April 9, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)