Renal DialysisPAMDNCT04066140
Patient Activation in Dialysis
An observational study of Renal Dialysis and Kidney Failure, Chronic, run by Satellite Healthcare at 36 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis, Kidney Failure, Chronic
- How many people
- 227 participants
- Where
- 36 sitesUnited States
- Study dates
- 17 Jun 2019to 17 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Incident dialysis patients commencing at Satellite Healthcare
Who may be able to join
- -Incident dialysis patients commencing at Satellite Healthcare during study recruitment dates
Who cannot join
- 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
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Satellite Healthcare Metric
Austin, Texas, 78758
Wellbound Austin
Austin, Texas, 78758
Satellite Dialysis Daly City
Daly City, California, 94014
Satellite Healthcare Kyle
Kyle, Texas, 78640
Satellite Healthcare Laredo South
Laredo, Texas, 78040
Satellite Healthcare Los Gatos
Los Gatos, California, 95032
Satellite Healthcare Poplar
Memphis, Tennessee, 38104
Satellite Healthcare Chickasaw Gardens
Memphis, Tennessee, 38111
WellBound Memphis
Memphis, Tennessee, 38117
Satellite Healthcare Merced
Merced, California, 95348
Satellite Healthcare Central Modesto
Modesto, California, 95354
WellBound Modesto
Modesto, California, 95354
Satellite Healthcare Modesto
Modesto, California, 95355
WellBound North Modesto
Modesto, California, 95356
Satellite Dialysis Morgan Hill
Morgan Hill, California, 95037
Satellite Healthcare Oakland
Oakland, California, 94609
Satellite Healthcare Orange
Orange, California, 92868
Satellite Healthcare Rohnert Park
Rohnert Park, California, 94928
Satellite Healthcare Round Rock
Round Rock, Texas, 78681
Satellite Wellbound Sacramento
Sacramento, California, 95821
Satellite Healthcare Sacramento
Sacramento, California, 95834
Satellite Healthcare San Carlos
San Carlos, California, 94070
Satellite Healthcare San Francisco
San Francisco, California, 94109
WellBound San Francisco
San Francisco, California, 94109
Satellite Dialysis Silver Creek
San Jose, California, 95121
Wellbound San Jose
San Jose, California, 95125
Satellite Healthcare
San Jose, California, 95821
Satellite Dialysis West San Leandro
San Leandro, California, 94577
Satellite Healthcare Santa Ana
Santa Ana, California, 92705
WellBound Santa Rosa
Santa Rosa, California, 95407
WellBound Stockton
Stockton, California, 95219
Satellite Dialysis Sunnyvale
Sunnyvale, California, 94086
Satellite Healthcare Tracy
Tracy, California, 95377
Satellite Healthcare Turlock
Turlock, California, 95302
WellBound Vallejo
Vallejo, California, 954590
Satellite Dialysis Watsonville
Watsonville, California, 95076
About this study
Official title: Patient Activation in Incident Dialysis
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.
Read the 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.
- Conditions
- Renal Dialysis, Kidney Failure, Chronic
- Being tested
- No intervention
- Keywords
- patient activation, self management
- Medical subject headings
- Kidney Failure, Chronic, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No Intervention. Observational Study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation
Patient Activation as measured by PAM-13 instrument
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start17 Jun 2019
- Primary completion8 Dec 2019
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wael Hussein, MD, Principal investigator, Satellite Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066140
- Sponsor's protocol ID
- SIH118PAMD
- Acronym
- PAMD
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall findings will be disseminated through publications and conference presentations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Activation in Incident Dialysis
- ClinicalTrials.gov ID
- NCT04066140
- Acronym / sponsor ID
- PAMD / SIH118PAMD
- Conditions
- Renal Dialysis, Kidney Failure, Chronic
- Keywords
- patient activation, self management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 8 Dec 2019 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Incident dialysis patients commencing at Satellite Healthcare
Key inclusion criteria (1 listed)
- -Incident dialysis patients commencing at Satellite Healthcare during study recruitment dates
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo Intervention. Observational Study. | Other | – |
Primary outcome
Patient Activation
Time frame: 3 months
Patient Activation as measured by PAM-13 instrument
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No. Overall findings will be disseminated through publications and conference presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Hussein, MD principal investigator
Satellite Healthcare
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Dialysis and Kidney Failure, Chronic, run by Satellite Healthcare at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.