Clinical trial NCT02580409: REACH Pilot Study (Rehabilitation Enhancing Aging Through Connected Health)
Official title: Maintaining Physical Independence in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Keywords: health care utilization
health care costs
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
name: Brandeis University
name: Massachusetts General Hospital
First posted: 2015-10-20
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Rehabilitation Enhancing Aging through Connected Health, REACH, is designed to evaluate the benefits of a novel rehabilitative care program on physical function utilizing mobile health technology to deliver patient centered care more efficiently and health care utilization after one year of follow up.

Detailed description: Rehabilitation Enhancing Aging through Connected Health, REACH, is designed to evaluate the benefits of a novel rehabilitative care program on physical function utilizing mobile health technology to deliver patient centered care more efficiently and health care utilization after one year of follow up. Study staff will recruit 76 community dwelling older adult primary care patients. The same procedures that were approved by the IRB for the Boston RISE cohort study will be used for REACH recruitment, screening and enrollment of potential participants. This process will be centered at Spaulding Cambridge Outpatient Clinic (SCOC). Potential participants will be contacted and a brief phone screen will be conducted. Eligible and interested participants will be scheduled for the consent/screen visit. If the participant consents, the study staff will administer three tests to determine final eligibility for study involvement. These include: Mini Mental Status Exam, the Short Physical Performance Battery (SPPB) and the Long Distance Corridor Walk.

Qualified participants will complete all baseline and 1-year assessments at SCOC. The assessments include: the Late Life Function and Disability Index (LLFDI), Hopkins Verbal Learning Test, Trail Making, Digit Symbol Substitution Test, Katz Comorbidity, depression (PHQ-9), Activities Specific Balance Scale, Barriers Specific Self-Efficacy Scale, Computer Attitude Scale, McGill Pain Map, Brief Pain Inventory, Figure 8 walk test, grip strength testing, single leg press strength and speed testing, ankle/knee ROM, the trunk extensor endurance test and stair climb power test.

The exercise/technology training with a licensed physical therapist will consist of 8-10 (with the possibility of up to 16 sessions) clinic or home visits interspersed over a 9-month period and will take place after baseline at one of two locations per choice of participant: SCOC or BU Center for Neurorehabilitation. During the clinic/home visits, the assigned exercises are video recorded using the Wellpepper clinician version housed on an iPad mini. During and after the in-person visits, the PTs will remotely monitor exercise adherence, provide feedback, progress the exercise program and answer participants' questions using the chat feature of the exercise app. PT support will be tapered over the course of this 9-month period as the participants become more successful at integrating exercise into their lives using the provided technology. Over the final 3 months of the study, participants will continue to perform exercises independently with reduced PT involvement. PT support will be available through the chat feature if participants have questions or concerns.

Participants will be contacted at quarterly intervals and asked to self-report recent falls, hospitalizations, ER visits and PT (outside of their participation in this study). At 6 months the LLFDI will be administered over the phone. In addition, the PT will perform these performance based assessments during a clinic visit: SPPB, ankle/knee ROM, trunk extensor endurance test and the stair climb power test.

Collaborators at Brandeis University will access CMS claims data for all participants during the year of participation and for an additional six months after study participation ends to evaluate health care utilization and health care costs after 1-year of follow up.

Eligibility criteria: Inclusion Criteria:

1. Ages 65-95 years
2. Able to understand and communicate in English
3. Difficulty or task modification with walking ½ mile (6 blocks) or climbing one flight of stairs
4. Ability to continuously walk 400 m in less than 15 minutes without stopping for more than a minute at a time, sitting, leaning, or the help of another person
5. Lives in a zip code within 10 mile radius of Spaulding Cambridge Facility
6. Baseline Short Physical Performance Battery (SPPB) scores from 3-12 with \<20% of SPPB scores in the 11-12 range

Exclusion Criteria:

1. Presence of a terminal disease (e.g. receiving hospice services, metastatic cancer)
2. Major surgery or Myocardial Infarction in the last 6 months
3. Planned major surgery (e.g. joint replacement)
4. Planned move from the Boston area within 1.5 years
5. Mini-mental state exam (MMSE) score \<20
6. Major medical problems interfering with safe and successful testing (examples may include: history hip replacement with recurrent dislocation, uncontrolled hypertension, use of supplemental oxygen)

Primary outcomes:
measure: Change in Late Life Function and Disability Index
timeFrame: Assessed at baseline visit, 6 months phone call after baseline visit and 12 months after baseline visit (1 year visit)
Secondary outcomes:
Other outcomes:
measure: Change in Hopkins Verbal Learning Test
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in Trail Making (Part A & B)
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in Digit Symbol Substitution Test
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Katz Comorbidity
timeFrame: Assessed at baseline visit
measure: Change in PHQ-9 (depression quuestionnaire)
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in Activities Specific Balance Scale
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in Barriers Specific Self-Efficacy Scale
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in Computer Attitude Scale
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in McGill Pain Map
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in Brief Pain Inventory
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in Figure 8 walk test
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in grip strength testing
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in single leg press strength and speed testing
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in trunk extensor endurance test
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in knee and ankle ROM
timeFrame: Assessed at baseline visit, 6 month assessment after baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in stair climb power test
timeFrame: Assessed at baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in Mini Mental Status Exam
timeFrame: Assessed at screen visit and 12 months after baseline visit (1 year visit)
measure: Change in the Short Physical Performance Battery (SPPB)
timeFrame: Assessed at screen visit, 6 month assessment after baseline visit and 12 months after baseline visit (1 year visit)
measure: Change in the Long Distance Corridor Walk
timeFrame: Assessed at screen visit and 12 months after baseline visit (1 year visit)
Locations:
city: Cambridge
country: United States
facility: Spaulding Rehabilitation Hospital Cambridge
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Jonathan F Bean, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bean JF, Brown L, DeAngelis TR, Ellis T, Kumar VSS, Latham NK, Lawler D, Ni M, Perloff J. The Rehabilitation Enhancing Aging Through Connected Health Prehabilitation Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):1999-2005. doi: 10.1016/j.apmr.2019.04.015. Epub 2019 May 29.
citation: Ni M, Brown LG, Lawler D, Ellis TD, Deangelis T, Latham NK, Perloff J, Atlas SJ, Percac-Lima S, Bean JF. The rehabilitation enhancing aging through connected health (REACH) study: study protocol for a quasi-experimental clinical trial. BMC Geriatr. 2017 Sep 20;17(1):221. doi: 10.1186/s12877-017-0618-x.