REACH Pilot Study (Rehabilitation Enhancing Aging Through Connected Health)

Mobility Limitation Clinical Trial

— REACH  

Official title:

Maintaining Physical Independence in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580409
• Other study ID #: 2015P000393
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mobility Limitation

Intervention

Behavioral:
• Exercise Intervention
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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital Cambridge	Cambridge	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Boston University, Brandeis University, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Hopkins Verbal Learning Test		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in Trail Making (Part A & B)		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in Digit Symbol Substitution Test		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Katz Comorbidity		Assessed at baseline visit
Other	Change in PHQ-9 (depression quuestionnaire)		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in Activities Specific Balance Scale		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in Barriers Specific Self-Efficacy Scale		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in Computer Attitude Scale		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in McGill Pain Map		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in Brief Pain Inventory		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in Figure 8 walk test		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in grip strength testing		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in single leg press strength and speed testing		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in trunk extensor endurance test		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in knee and ankle ROM		Assessed at baseline visit, 6 month assessment after baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in stair climb power test		Assessed at baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in Mini Mental Status Exam		Assessed at screen visit and 12 months after baseline visit (1 year visit)
Other	Change in the Short Physical Performance Battery (SPPB)		Assessed at screen visit, 6 month assessment after baseline visit and 12 months after baseline visit (1 year visit)
Other	Change in the Long Distance Corridor Walk		Assessed at screen visit and 12 months after baseline visit (1 year visit)
Primary	Change in Late Life Function and Disability Index		Assessed at baseline visit, 6 months phone call after baseline visit and 12 months after baseline visit (1 year visit)