NCT06882863

Brief Summary

This feasibility study aims to assess the practicality and acceptability of a nurse-led motivational interview intervention designed to reduce sedentary behavior in patients with severe Chronic Obstructive Pulmonary Disease (COPD). The study will evaluate the recruitment process, patient adherence, and the usability of accelerometers for objectively measuring sedentary time. A total of 10-12 patients with severe COPD will be recruited and receive individual motivational interviews conducted by trained nurses in their homes. The intervention will be based on motivational interviewing (MI) and Cognitive Behavioral Therapy (CBT) principles, focusing on helping patients identify barriers and set realistic goals to increase physical activity. The study will determine whether patients tolerate wearing accelerometers for seven days at different time points and whether the intervention is acceptable to both patients and nurses. Insights gained from this feasibility study will guide refinements to the intervention before launching a randomized controlled trial (RCT) to test its effectiveness on a larger scale.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress54%
Mar 2025Jul 2027

First Submitted

Initial submission to the registry

March 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 19, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

March 11, 2025

Last Update Submit

March 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility and acceptability of the intervention

    Measured by the number of participants who successfully complete the intervention.

    From enrollment to one week post-intervention

Secondary Outcomes (3)

  • questionnaire

    From enrollment to one week post-intervention

  • questionnaire

    From enrollment to one week post-intervention

  • questionnaire

    From enrollment to one week post-intervention

Study Arms (1)

Feasibility

EXPERIMENTAL

This feasibility study involves a single-arm intervention where patients with severe COPD receive nurse-led motivational interviews to reduce sedentary behavior. Participants recieve one 60 minute intervention, focusing on identifying barriers, setting small activity goals, and building motivation using motivational interviewing (MI) and Cognitive Behavioral Therapy (CBT) techniques. Participants wear accelerometers for seven days before the intervention to measure changes in sedentary time. The study assesses recruitment feasibility, adherence, and patient acceptability, informing refinements before a future randomized controlled trial (RCT).

Behavioral: Motivational interviewing

Interventions

This intervention consists of a single nurse-led motivational interview aimed at reducing sedentary behavior in patients with severe COPD. The session, conducted in the patient's home, lasts approximately 60 minutes and focuses on identifying personal barriers, exploring motivation, and setting small, realistic goals to reduce sedentary time. Unlike traditional pulmonary rehabilitation, this intervention does not involve structured exercise but instead uses motivational interviewing (MI) techniques to encourage gradual behavior change in daily routines. Before the intervention, patients wear an accelerometer for seven days to objectively measure baseline sedentary time. The study assesses feasibility, patient engagement, and adherence to determine whether the approach is suitable for a larger randomized controlled trial (RCT).

Feasibility

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosed with severe COPD confirmed by a healthcare provider.
  • Aged 65 years or older at the time of enrollment.
  • Self-reported sedentary behavior of at least 5 hours per day.
  • Able to provide informed consent and participate in a home-based interview.
  • Not currently enrolled in a structured pulmonary rehabilitation program.

You may not qualify if:

  • Severe cognitive impairment that prevents meaningful participation in the motivational interview.
  • Physical disability that completely prevents movement and makes physical activity recommendations irrelevant.
  • Severe comorbidities with a life expectancy of less than six months.
  • Inability to understand or communicate in Danish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 19, 2025

Study Start

March 19, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 25, 2025

Record last verified: 2025-02

Locations