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| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 30, 2003 |
| Last Updated Date | August 29, 2009 |
| Start Date ICMJE | December 2003 |
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00075036 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Patient-Provider Trust Among Individuals With End-Stage Kidney Disease |
| Official Title ICMJE | Exploring Patient-Provider Trust Among Individuals With End-Stage Renal Disease |
| Brief 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, 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:
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 are 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 Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE | Kidney Failure, Chronic |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 336 |
| Completion Date | |
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE |
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:
EXCLUSION CRITERIA:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00075036 |
| Responsible Party | |
| Study ID Numbers ICMJE | 040070, 04-CC-0070 |
| Study Sponsor ICMJE | National Institutes of Health Clinical Center (CC) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | August 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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