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Patient Activation in Dialysis (PAMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066140
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Satellite Healthcare

Brief Summary:
Patient activation refers to patients' willingness and ability to make independent actions to manage their health and care and requires knowledge, skill and confidence. This study aims to explore activation levels of incident dialysis patients at start of dialysis and after 3 months of dialysis.

Condition or disease Intervention/treatment
Renal Dialysis Kidney Failure, Chronic Other: No intervention

Detailed Description:
Patient activation refers to patients' willingness and ability to make independent actions to manage their health and care and requires knowledge, skill and confidence. This study aims to explore activation levels, using the 13 item PAM-13 survey, of incident dialysis patients at start of dialysis and after 3 months of dialysis.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Activation in Incident Dialysis
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : April 8, 2020
Estimated Study Completion Date : June 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis


Intervention Details:
  • Other: No intervention
    No Intervention. Observational Study.


Primary Outcome Measures :
  1. Patient Activation [ Time Frame: 3 months ]
    Patient Activation as measured by PAM-13 instrument



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Incident dialysis patients commencing at Satellite Healthcare
Criteria

Inclusion Criteria:

-Incident dialysis patients commencing at Satellite Healthcare during study recruitment dates

Exclusion Criteria:

  • Age < 18 years
  • Started dialysis more than 3 weeks prior to identification
  • Transitioning to dialysis at a participating center from a non-participating center, when that patient has been on dialysis for more than 3 weeks at any center.
  • Transitioning to dialysis after kidney transplant failure
  • Inability to participate because of cognitive impairment or active psychological condition

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): NCT04066140


Contacts
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Contact: Paul Bennett, PhD 6505212213 p.bennett@deakin.edu.au
Contact: Veronica Legg, MS 3606076892 leggv@satellitehealth.com

Locations
Show Show 36 study locations
Sponsors and Collaborators
Satellite Healthcare
Investigators
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Principal Investigator: Wael Hussein, MD Satellite Healthcare
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Responsible Party: Satellite Healthcare
ClinicalTrials.gov Identifier: NCT04066140    
Other Study ID Numbers: SIH118PAMD
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Overall findings will be disseminated through publications and conference presentations.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Satellite Healthcare:
patient activation
self management
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic