NCT01349608

Brief Summary

This study is designed to explore a new approach to help people with chronic obstructive pulmonary disease (COPD) become more physically active. Through weekly telephone sessions with a health coach utilizing motivational interviewing, participants will be empowered to set goals for increased physical activity (emphasis on walking). The objective of the study is to determine if telephone-based health coaching is a reasonable and effective way to increase physical activity, as measured by a gold-standard activity monitor, in people with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.9 years

First QC Date

May 2, 2011

Last Update Submit

April 1, 2013

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseMotivational InterviewingHealth CoachingPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of telephone-based health coaching in COPD.

    Determine the effectiveness of a telephone-based health coaching intervention on daily physical activity level, as measured by a gold-standard activity monitor and daily pedometer record, acceptability of intervention through qualitative interviews with participants, and health-related quality of life as measured by questionnaires.

    3 Months

Study Arms (1)

Health coaching

EXPERIMENTAL
Behavioral: Telephonic health coaching

Interventions

Participants will be given a pedometer and activity log to use daily to track their physical activity accomplishments. Weekly, they will participate in a health coaching telephone session to discuss physical activity and set goals. The health coach is knowledgable in COPD care and will utilize a motivational interviewing approach to support the self-efficacy of the participants to be more active.

Health coaching

Eligibility Criteria

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

You may qualify if:

  • Men and women age 40 years and older
  • Current or former cigarette smoker of at least 10 pack-years
  • Diagnosis of COPD stage II to IV COPD as documented by pulmonary function testing (FEV1 \<80% predicted, FEV1/FVC ration \<0.71) within the past 24 months
  • Able to ambulate independently or with a walking aid (wheeled or standard walker or cane)

You may not qualify if:

  • Unable to walk without assistance of another person
  • patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not able to be contacted by telephone
  • patients with an inability to provide good data or follow commands (patients who are disoriented or have a severe neurologic/psychiatric condition)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Roberto P Benzo, M.D., MSc

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

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
Consultant Pulmonary and Critical Care Medicine

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 6, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations