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REACH Pilot Study (Rehabilitation Enhancing Aging Through Connected Health) (REACH)

Primary Purpose

Mobility Limitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mobility Limitation focused on measuring health care utilization, health care costs

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Spaulding Rehabilitation Hospital Cambridge

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm studies

Arm Description

Behavioral Intervention

Outcomes

Primary Outcome Measures

Change in Late Life Function and Disability Index

Secondary Outcome Measures

Full Information

First Posted
October 14, 2015
Last Updated
April 22, 2019
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Boston University, Brandeis University, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02580409
Brief Title
REACH Pilot Study (Rehabilitation Enhancing Aging Through Connected Health)
Acronym
REACH
Official Title
Maintaining Physical Independence in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Boston University, Brandeis University, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
Keywords
health care utilization, health care costs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm studies
Arm Type
Other
Arm Description
Behavioral Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Investigators are proposing an innovative rehabilitative care program for older primary care patients at risk for mobility decline. The program targets newly identified risk factors for mobility decline and utilizes mobile health technology to deliver patient centered care more efficiently. Study participants will receive exercise instruction with a licensed physical therapist for an average of 8-10 training sessions, with the possibility of up to 16 sessions. some at home and some in the clinic. The exercise training sessions will focus on improving mobility, balance and ability to get up from a chair with the use of an exercise application (Wellpepper) being used on a study issued iPad.
Primary Outcome Measure Information:
Title
Change in Late Life Function and Disability Index
Time Frame
Assessed at baseline visit, 6 months phone call after baseline visit and 12 months after baseline visit (1 year visit)
Other Pre-specified Outcome Measures:
Title
Change in Hopkins Verbal Learning Test
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in Trail Making (Part A & B)
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in Digit Symbol Substitution Test
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Katz Comorbidity
Time Frame
Assessed at baseline visit
Title
Change in PHQ-9 (depression quuestionnaire)
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in Activities Specific Balance Scale
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in Barriers Specific Self-Efficacy Scale
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in Computer Attitude Scale
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in McGill Pain Map
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in Brief Pain Inventory
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in Figure 8 walk test
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in grip strength testing
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in single leg press strength and speed testing
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in trunk extensor endurance test
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in knee and ankle ROM
Time Frame
Assessed at baseline visit, 6 month assessment after baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in stair climb power test
Time Frame
Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in Mini Mental Status Exam
Time Frame
Assessed at screen visit and 12 months after baseline visit (1 year visit)
Title
Change in the Short Physical Performance Battery (SPPB)
Time Frame
Assessed at screen visit, 6 month assessment after baseline visit and 12 months after baseline visit (1 year visit)
Title
Change in the Long Distance Corridor Walk
Time Frame
Assessed at screen visit and 12 months after baseline visit (1 year visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages 65-95 years Able to understand and communicate in English Difficulty or task modification with walking ½ mile (6 blocks) or climbing one flight of stairs 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 Lives in a zip code within 10 mile radius of Spaulding Cambridge Facility Baseline Short Physical Performance Battery (SPPB) scores from 3-12 with <20% of SPPB scores in the 11-12 range Exclusion Criteria: Presence of a terminal disease (e.g. receiving hospice services, metastatic cancer) Major surgery or Myocardial Infarction in the last 6 months Planned major surgery (e.g. joint replacement) Planned move from the Boston area within 1.5 years Mini-mental state exam (MMSE) score <20 Major medical problems interfering with safe and successful testing (examples may include: history hip replacement with recurrent dislocation, uncontrolled hypertension, use of supplemental oxygen)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan F Bean, MD, MS, MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital Cambridge
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31152705
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.
Results Reference
derived
PubMed Identifier
28931377
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.
Results Reference
derived

Learn more about this trial

REACH Pilot Study (Rehabilitation Enhancing Aging Through Connected Health)

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