STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis

NCT ID: NCT04018495

Last Updated: 2025-02-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-10

Study Completion Date

2022-08-24

Brief Summary

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STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF. A pilot in integration of wearable fitness tracker data with existing health data provided by CF foundation Patient Registry (Port CF)

Detailed Description

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Cystic fibrosis patients who are willing to use an activity tracker for 3 months are invited to participate. Analysis of activity patterns and sleep patterns will be analyzed and compared to their lung function and general health as part of the routine CF center care visits during the study period.

Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CF patients using Fitbit for 3 months

CF patients at time of enrollment who are willing to use a fitbit tracker to measure activity and sleep during the observational period of 3 months.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adults with Cystic Fibrosis
* Age \>18, Cystic Fibrosis

Exclusion Criteria

* Those unable to commit to at least 3 months follow up for CF care from enrollment at study CF center. Inability to speak and understand English.
* Those patients without dedicated access to a smartphone, tablet, or computer with internet for syncing device and completing patient diary.
* Those patients unwilling to sign an informed consent form.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Rose Franco

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rose Franco, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Amin R, Bean J, Burklow K, Jeffries J. The relationship between sleep disturbance and pulmonary function in stable pediatric cystic fibrosis patients. Chest. 2005 Sep;128(3):1357-63. doi: 10.1378/chest.128.3.1357.

Reference Type BACKGROUND
PMID: 16162729 (View on PubMed)

Beattie Z, Oyang Y, Statan A, Ghoreyshi A, Pantelopoulos A, Russell A, Heneghan C. Estimation of sleep stages in a healthy adult population from optical plethysmography and accelerometer signals. Physiol Meas. 2017 Oct 31;38(11):1968-1979. doi: 10.1088/1361-6579/aa9047.

Reference Type BACKGROUND
PMID: 29087960 (View on PubMed)

Dancey DR, Tullis ED, Heslegrave R, Thornley K, Hanly PJ. Sleep quality and daytime function in adults with cystic fibrosis and severe lung disease. Eur Respir J. 2002 Mar;19(3):504-10. doi: 10.1183/09031936.02.00088702.

Reference Type BACKGROUND
PMID: 11936530 (View on PubMed)

de Zambotti M, Baker FC, Colrain IM. Validation of Sleep-Tracking Technology Compared with Polysomnography in Adolescents. Sleep. 2015 Sep 1;38(9):1461-8. doi: 10.5665/sleep.4990.

Reference Type BACKGROUND
PMID: 26158896 (View on PubMed)

Gonzalez-Ortiz M, Martinez-Abundis E, Balcazar-Munoz BR, Pascoe-Gonzalez S. Effect of sleep deprivation on insulin sensitivity and cortisol concentration in healthy subjects. Diabetes Nutr Metab. 2000 Apr;13(2):80-3.

Reference Type BACKGROUND
PMID: 10898125 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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http://www.cysticfibrosis.org.uk/the-work-we-do/uk-cf-registry/reporting-and-resources

Sample size requirements for estimating Pearson, Kendall and Spearman Correlations. Insufficient sleep is a public health problem. Cystic Fibrosis Trust Cystic Fibrosis Registry Report

Other Identifiers

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34812

Identifier Type: -

Identifier Source: org_study_id

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