A Randomized Controlled Trial of a Pre-Transplant Education Intervention

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Kidney transplantation is the best treatment for most patients with end-stage kidney disease, but it is an extremely complicated process. To become active on the transplant waitlist, patients must learn new information, navigate the healthcare system and undergo several specialized tests. After the transplant, another set of challenges emerge. Transplant recipients must commit to lifelong therapy with immunosuppressive medications and adapt to lifestyle changes. Up to half of all patients have difficulty taking the medications as prescribed, which can lead to transplant rejection, kidney loss, and death. The transplant process is challenging and confusing; however, increasing education and support to transplant candidates demands greater use of care providers' time and resources in a health care system that is already stretched. A patient-oriented video series has been developed according to best practices for transplant education, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives provide support and encouragement. 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 and beliefs in medications as compared to usual care. Participants will be randomized (1:1) to the control group, or the intervention group, who will be provided access to the video series, in addition, to standard of care. Differences in changes in transplant knowledge, self-efficacy, beliefs about medicines, quality of life, and education satisfaction will be evaluated by a pre-and post-intervention survey. A thorough assessment of video-viewing habits and satisfaction with the intervention will provide insight on the feasibility of expanding home-based education to other health settings. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03633136
Study type	Interventional
Source	University of Saskatchewan
Contact
Status	Completed
Phase	N/A
Start date	June 1, 2018
Completion date	July 7, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05559255` - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI	N/A
Completed	`NCT06238557` - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT05472935` - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers	N/A
Recruiting	`NCT04444544` - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed	`NCT04281953` - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting	`NCT05546931` - Mobile Health Program for Rural Hypertension	N/A
Active, not recruiting	`NCT04746664` - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia	N/A
Completed	`NCT05387174` - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period	N/A
Recruiting	`NCT04142827` - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)	N/A
Active, not recruiting	`NCT05903638` - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility	N/A
Completed	`NCT05538455` - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases	N/A
Completed	`NCT06216015` - Exercise Training and Kidney Transplantation	N/A
Completed	`NCT03813420` - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level	N/A
Recruiting	`NCT05550545` - Infant RSV Infections and Health-related Quality of Life of Families
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Recruiting	`NCT05233020` - Robotic Versus Hybrid Assisted Ventral Hernia Repair	N/A
Terminated	`NCT03304184` - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life	Phase 3
Completed	`NCT05063305` - Probiotics, Immunity, Stress, and QofL	N/A
Recruiting	`NCT05380856` - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.