NCT03865329

Brief Summary

This pilot study will look at investigating barriers, facilitators, adherence and effectiveness of an interactive home-based pulmonary rehabilitation program and health coaching for patients who have recently been hospitalized for a COPD related cause.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 10, 2020

Completed
Last Updated

August 10, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

January 21, 2019

Results QC Date

June 17, 2020

Last Update Submit

July 24, 2020

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (4)

  • Adherence to One Balance Practice Routine

    Percentage of participants to adhere to one balance practice routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program

    Baseline to 3 months

  • Adherence to Two Balance Practice Routine

    Percentage of participants to adhere to two balance practices routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program

    Baseline to 3 months

  • Adherence to Daily Flexible Practice Routine

    Percentage of participants to adhere to the daily flexible practice routine for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program

    Baseline to 3 months

  • Completion of the Daily Self-assessment

    Percentage of participants to complete the daily self-assessment for 6 out of the 7 days for 12 weeks via the interactive home-based pulmonary rehabilitation program

    Baseline to 3 months

Secondary Outcomes (5)

  • Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary

    Baseline, 3 months

  • Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary

    Baseline, 3 months

  • Daily Physical Activity

    3 months

  • Change in the Self-Management Ability Scale (SMAS) Total Score

    Baseline, 3 months

  • Change in Patient Health Questionnaire (PHQ-2)

    Baseline, 3 months

Study Arms (1)

Intervention- Home Pulmonary Rehabilitation

EXPERIMENTAL

Participants will be offered a Home-based pulmonary rehabilitation program with health coaching.

Behavioral: Intervention- Home-based Pulmonary Rehabilitation

Interventions

Intervention- Home-based Pulmonary RehabilitationBEHAVIORAL

Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).

Intervention- Home Pulmonary Rehabilitation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD related hospitalization and eligible for PR
  • Age 40+
  • Confidence (score \> 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)

You may not qualify if:

  • Inability to walk (orthopedic-neurologic problems or confined to bed)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Results Point of Contact

Title
Dr. Roberto Benzo
Organization
Mayo Clinic
Benzo.Roberto@mayo.edu
(507) 284-0561

Study Officials

  • Roberto P Benzo, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2019

First Posted

March 6, 2019

Study Start

January 20, 2018

Primary Completion

August 2, 2019

Study Completion

August 2, 2019

Last Updated

August 10, 2020

Results First Posted

August 10, 2020

Record last verified: 2020-07

Locations

US(1)