Quality of Life Clinical Trial
Official title:
Improving Health Outcomes of Kidney Recipients: A Randomized Controlled Trial of a Pre-Transplant Education Intervention
NCT number | NCT03633136 |
Other study ID # | 99302 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | July 7, 2020 |
Verified date | November 2020 |
Source | University of Saskatchewan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A multi-center, randomized, controlled clinical trial will be conducted to test the effectiveness of a home-based video intervention on improving kidney transplant candidate's knowledge, self-efficacy, quality of life, beliefs in medications, and education satisfaction as compared to usual care.
Status | Completed |
Enrollment | 162 |
Est. completion date | July 7, 2020 |
Est. primary completion date | July 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 or older - can speak and understand and read English - are being assessed or wait-listed for kidney transplantation Exclusion Criteria: - do not meet inclusion criteria |
Country | Name | City | State |
---|---|---|---|
Canada | Southern Alberta Transplant Program | Calgary | Alberta |
Canada | Saskatchewan Transplant Program | Regina | Saskatchewan |
Canada | Saskatchewan Transplant Program | Saskatoon | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan | Saskatchewan Center for Patient-Oriented Research, Saskatchewan Health Authority - Regina Area, Saskatchewan Health Research Foundation, Southern Alberta Transplant Program |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in transplant knowledge score between the intervention and control groups as measured by the Kidney Transplant Understanding Tool (K-TUT) | Measured by the Kidney Transplant Understanding Tool (K-TUT) (self-reported electronic survey). The K-TUT consists of 9 true/false and 13 multiple-choice questions, and scores are based on the number correct answers [YES/ NO format] of 69 items. | 1 month | |
Secondary | Difference in self-efficacy between the intervention and control group as measured by the Generalized Self Efficacy Scale (GSE) | Measured by the Generalized Self Efficacy Scale (GSE) (self-reported electronic survey).The GSE measures an individual's self-beliefs in their ability to cope with various demands in life. It is a 10-item psychometric scale with a score for each item ranging from 1 to 4. The scores are summed and a higher score indicates stronger patient beliefs in self-efficacy. | 1 month | |
Secondary | Difference in quality of life between the intervention and control group as measured by the Short Form-12 (SF-12) | Measured by the Short Form-12 (SF-12) (self-reported electronic survey). The SF-12 is a 12-item psychometric scale that measures functional health and well-being. Responses are indicated on a likert scale and aggregated into two sub scales; the mental component summary (MCS) and the physical component summary (PCS). The scores are converted to adjusted norm-based values of a healthy individual with a midpoint score of 50 indicating average health comparable to norm values. | 1 month | |
Secondary | Difference in beliefs of medicine between the intervention and control group as measured by the Beliefs of Medicine Questionnaire (BMQ) | Measured by the Beliefs of Medicine Questionnaire (BMQ) (self-reported electronic survey). The BMQ is an 18-item psychometric questionnaire which consists of two subscales. The BMQ-Specific assesses perceptions of medication prescribed for personal use, while the BMQ-General assesses beliefs about medications in general. The BMQ-General can be further classified into domain of General-Harm and General-Overuse. Items are scored on a 5-point likert scale, with higher score indicating stronger beliefs in each subscale. | 1 month | |
Secondary | Difference in education satisfaction between the intervention and control group as measured by self-reported electronic survey | Measured by self-reported electronic survey | 1 month |
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