Kidney Failure, ChronicNCT00075036
Patient-Provider Trust Among Individuals With End-Stage Kidney Disease
An observational study of Kidney Failure, Chronic, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial summary
This study will examine communication and trust between patients in the kidney transplant process and their health care providers. It will assess patients' perception of trust in their physician and nurse coordinator; determine the patients' level of trust in the areas of competence, compassion, control… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- How many people
- 113 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Feb 2004to 13 Sep 2019
- 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
Who may be able to join
- The investigators will interview a cohort of patients from Walter Reed Army Medical Center and the NIDDK intramural program in various stages of the transplant process. The stages are divided into the following categories:
- individuals on dialysis but not on a waiting list
- individuals on the organ waiting list who are also on dialysis
- individuals on the organ waiting list but not on dialysis
- individuals who have had a kidney transplant within the last year
- individuals who have had a kidney transplant greater than one year
Who cannot join
- Patients less than 18 years old will not be included in this study. The interview questions and responses to the instruments may be inappropriate for children.
- All other exclusions are as stated in the NIDDK and WRAMC parent protocols.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20301
About this study
Official title: Exploring Patient-Provider Trust Among Individuals With End-Stage Renal Disease
This study will examine communication and trust between patients in the kidney transplant process and their health care providers. It will assess patients' perception of trust in their physician and nurse coordinator; determine the patients' level of trust in the areas of competence, compassion, control, communication, and confidentiality; and determine how the trust level varies as patients progress in the transplant process.
Patients 18 years of age and older who are in various stages of the kidney transplant process at Walter Reed Army Medical Center and the NIH Clinical Center may be eligible for this study. Candidates include individuals who:
Read more
- are on dialysis but not on a transplant waiting list
- are on the organ waiting list and are also on dialysis
- are on the organ waiting list but are not on dialysis
- have had a kidney transplant within the last year.
Participants will be interviewed by someone who is not their direct health care provider about the doctor/patient, primary provider/patient, or nurse/patient relationship, their health history, medical condition, and ideas about their care. With the patient's permission, parts of the interview will be tape-recorded. The interview will take about 30 to 40 minutes.
Read the detailed description
Health disparities related to the provision of, and access to, healthcare in the United States are well documented across racial and ethnic groups. One area of particular interest to health disparities researchers has been solid organ transplantation. Both provider and patient behaviors are implicated as contributing to ethnic variance of medical care in kidney transplantation. This pilot study will explore the perceptions of trust among patients in the kidney transplant process at the Warren Magnuson Clinical Center at the National Institutes of Health and at Walter Reed Army Medical Center. For sampling purposes the transplant process is defined as 1) patients currently on dialysis; 2) patients on the transplantation waiting list receiving dialysis; 3) patients on the transplantation waiting list not receiving dialysis; 4) patients newly transplanted (less than or equal to one year since transplantation) and 5) patients transplanted for greater than one year. Five dimensions contributing to trust have been identified in the literature: competence, compassion, control, communication and confidentiality. Face-to-face interviews to explore these five dimensions will include questions regarding demographic variables, the Trust in Physician Scale; the Trust in Nurse Scale, and the Patient Trust Scale. Results will be analyzed using descriptive statistics, Chi-square for categorical comparison of means and multivariate analysis for differences between groups.
- Conditions
- Kidney Failure, Chronic
- Keywords
- Health Disparities, Transplantation, Trust, Interview, Ethnic Bias
- Medical subject headings
- Kidney Failure, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2003 (estimated)
- Study start27 Feb 2004
- Study completion13 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Walter Reed Army Medical Center
- Responsible party
- Sponsor
- Investigators
- Lori A Purdie, R.N., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075036
- Sponsor's protocol ID
- 040070
- Other IDs
- 04-CC-0070
- Status last verified
- 13 Sep 2019
- First submitted
- 30 Dec 2003
- Last updated
- 17 Sep 2019
- Results posted
- No
Publications
Cain VS, Kington RS. Investigating the role of racial/ethnic bias in health outcomes. Am J Public Health. 2003 Feb;93(2):191-2. doi: 10.2105/ajph.93.2.191. No abstract available.
PubMed 12554567Furth SL, Garg PP, Neu AM, Hwang W, Fivush BA, Powe NR. Racial differences in access to the kidney transplant waiting list for children and adolescents with end-stage renal disease. Pediatrics. 2000 Oct;106(4):756-61. doi: 10.1542/peds.106.4.756.
PubMed 11015519Eggers PW. Racial differences in access to kidney transplantation. Health Care Financ Rev. 1995 Winter;17(2):89-103.
PubMed 10157383
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Patient-Provider Trust Among Individuals With End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT00075036
- Acronym / sponsor ID
- 040070
- Conditions
- Kidney Failure, Chronic
- Keywords
- Health Disparities, Transplantation, Trust, Interview, Ethnic Bias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- Walter Reed Army Medical Center
- Study start
- 27 Feb 2004
- Study completion
- 13 Sep 2019
- First posted
- 31 Dec 2003 (estimated)
- 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.
This study will examine communication and trust between patients in the kidney transplant process and their health care providers. It will assess patients' perception of trust in their physician and nurse coordinator; determine the patients' level of trust in the areas of competence, compassion, control, communication, and confidentiality; and determine how the trust level varies as patients progress in the transplant process.
Patients 18 years of age and older who are in various stages of the kidney transplant process at Walter Reed Army Medical Center and the NIH Clinical Center may be eligible for this study. Candidates include individuals who:
- are on dialysis but not on a transplant waiting list
- are on the organ waiting list and are also on dialysis
- are on the organ waiting list but are not on dialysis
- have had a kidney transplant within the last year.
Participants will be interviewed by someone who is not their direct health care provider about the doctor/patient, primary provider/patient, or nurse/patient relationship, their health history, medical condition, and ideas about their care. With the patient's permission, parts of the interview will be tape-recorded. The interview will take about 30 to 40 minutes.
Detailed description
Health disparities related to the provision of, and access to, healthcare in the United States are well documented across racial and ethnic groups. One area of particular interest to health disparities researchers has been solid organ transplantation. Both provider and patient behaviors are implicated as contributing to ethnic variance of medical care in kidney transplantation. This pilot study will explore the perceptions of trust among patients in the kidney transplant process at the Warren Magnuson Clinical Center at the National Institutes of Health and at Walter Reed Army Medical Center. For sampling purposes the transplant process is defined as 1) patients currently on dialysis; 2) patients on the transplantation waiting list receiving dialysis; 3) patients on the transplantation waiting list not receiving dialysis; 4) patients newly transplanted (less than or equal to one year since transplantation) and 5) patients transplanted for greater than one year. Five dimensions contributing to trust have been identified in the literature: competence, compassion, control, communication and confidentiality. Face-to-face interviews to explore these five dimensions will include questions regarding demographic variables, the Trust in Physician Scale; the Trust in Nurse Scale, and the Patient Trust Scale. Results will be analyzed using descriptive statistics, Chi-square for categorical comparison of means and multivariate analysis for differences between groups.
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
Key inclusion criteria (6 listed)
- The investigators will interview a cohort of patients from Walter Reed Army Medical Center and the NIDDK intramural program in various stages of the transplant process. The stages are divided into the following categories:
- individuals on dialysis but not on a waiting list
- individuals on the organ waiting list who are also on dialysis
- individuals on the organ waiting list but not on dialysis
- individuals who have had a kidney transplant within the last year
Key exclusion criteria (2 listed)
- Patients less than 18 years old will not be included in this study. The interview questions and responses to the instruments may be inappropriate for children.
- All other exclusions are as stated in the NIDDK and WRAMC parent protocols.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 17 Sep 2019.
- Background: PubMed 12554567Cain VS, Kington RS. Investigating the role of racial/ethnic bias in health outcomes. Am J Public Health. 2003 Feb;93(2):191-2. doi: 10.2105/ajph.93.2.191. No abstract available.
- Background: PubMed 11015519Furth SL, Garg PP, Neu AM, Hwang W, Fivush BA, Powe NR. Racial differences in access to the kidney transplant waiting list for children and adolescents with end-stage renal disease. Pediatrics. 2000 Oct;106(4):756-61. doi: 10.1542/peds.106.4.756.
- Background: PubMed 10157383Eggers PW. Racial differences in access to kidney transplantation. Health Care Financ Rev. 1995 Winter;17(2):89-103.
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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.
Lori A Purdie, R.N. principal investigator
National Institutes of Health Clinical Center (CC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic, run by National Institutes of Health Clinical Center (CC) at 2 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 6 inclusion and 2 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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00075036, which also lists 3 linked publications.
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 17 Sep 2019.