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A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices (PATTErn)

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ClinicalTrials.gov Identifier: NCT03544424
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Joanne Taylor, University of Manchester

Brief Summary:
An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)

Condition or disease Intervention/treatment
Physical Activity Aging Cardiac Disease Other: No intervention

Detailed Description:
Study Type: observational, investigator led Study Design: observational model: cohort (retrospective) Population: 150 people over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK Data collection: daily PA measures, demographic details, co-morbidity status, physical frailty assessment, functional status, quality of life (QOL) and NEHA data Consent: for participation in the study, physical frailty assessment, additional collection of retrospective CIED data, and access to electronic patient records Data sources: CIED downloads, self-report questionnaire, physical measurements (height, weight, hand grip strength, gait speed), electronic hospital records, HES (hospital episode statistics) data Results analysis: data will be analysed to investigate: daily PA variability; the association between PA and NEHAs, and the impact of frailty on PA patterns

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : April 12, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study cohort
People over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Non-elective hospitalisation episodes [ Time Frame: Retrospective, previous 400 days ]
    All cause



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People 60 years or older with CIED in situ for at least 6 months
Criteria

Inclusion Criteria:

  1. Age 60+ years
  2. Functioning CIED in situ for at least 6 months
  3. Medtronic manufactured device compatible with CareLink® Cardiac Compass application (platform which measures and stores physiological parameters)
  4. Lives in the Greater Manchester area
  5. Able and willing to given written, informed consent to enter the study

Exclusion Criteria:

  1. Faulty or incompatible device
  2. Immobile (unable to walk in upright position)
  3. Active participant in a clinical trial which does not allow concurrent recruitment into this study
  4. People unable to consent in the English language (including the understanding of study literature which is published in English only)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544424


Contacts
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Contact: Dr Taylor, MBChB 0161 306 0679 joanne.taylor-2@manchester.ac.uk

Locations
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United Kingdom
Manchester Heart Centre Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Joanne Taylor       joanne.taylor4@mft.nhs.uk   
Sponsors and Collaborators
University of Manchester
Investigators
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Study Director: Adam Greenstein, MBChB, PhD Manchester University

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Responsible Party: Dr Joanne Taylor, Clinical Fellow in Cardiology, Postgraduate Student, University of Manchester
ClinicalTrials.gov Identifier: NCT03544424     History of Changes
Other Study ID Numbers: 215964
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases