Home-Based Health Management of COPD Patients

NCT ID: NCT02557178

Last Updated: 2021-02-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-03-31

Brief Summary

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Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete home exercise as part of pulmonary rehabilitation (PR). The proposed system has two components: home-based activity monitoring and health coaching. The investigators will conduct a randomized, wait-list controlled clinical study to evaluate the effects of the activity monitoring system and health coaching on quality of life and daily steps.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Activity Monitor plus Health Coaching

Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.

Group Type EXPERIMENTAL

health coaching

Intervention Type BEHAVIORAL

Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.

Control

Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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health coaching

Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* diagnosis of GOLD stage II, III, or IV COPD
* current or previous smoker with at least 10 pack-years of cigarette smoking
* be hospitalized for an exacerbation of COPD

Exclusion Criteria

* high likelihood of being lost to follow-up or contact
* inability to provide good data or follow commands
* inability to do mild exercise
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Sara Seifert

INDUSTRY

Sponsor Role lead

Responsible Party

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Sara Seifert

President

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sara Seifert, MPH

Role: PRINCIPAL_INVESTIGATOR

Minnesota HealthSolutions

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Benzo RP, Ridgeway J, Hoult JP, Novotny P, Thomas BE, Lam NM, V Benzo M, Kramer K, Seifert S. Feasibility of a Health Coaching and Home-Based Rehabilitation Intervention With Remote Monitoring for COPD. Respir Care. 2021 Jun;66(6):960-971. doi: 10.4187/respcare.08580. Epub 2021 Apr 27.

Reference Type DERIVED
PMID: 33906954 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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R44HL114162

Identifier Type: NIH

Identifier Source: secondary_id

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R44HL114162-02A1

Identifier Type: NIH

Identifier Source: org_study_id

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