Renal Replacement Therapies Decision Aids

December 18, 2022 updated by: China Medical University Hospital

Developing and Effectiveness Evaluation of Web-based Situation Renal Replacement Therapies Patient Decision Aids

Different renal replacement therapy methods will cause significant impacts on the physical, mental, and social for patients with end-stage renal disease. Application shared decision-making should be able to effectively assist patients in choosing suitable renal replacement therapy. Currently, most of the patient decision aid of renal replacement therapy are written health education leaflets, which have problems such as too many words, more difficult content, and inconvenience. In shared decision-making, even though different treatment options are communicated to patients, there is still a gap between "understanding" and "real experience", it will be creating uncertainty of decision, and emphasizing true situational learning strategies should be a viable auxiliary method. Therefore, this study aims to develop a web-based patient decision aid of renal replacement therapy and integrates situational learning strategies into it. First, investigators have conducted a qualitative study to explore the related experience of patients with end-stage renal disease the decision-making needs in renal replacement therapy choice, and the experience and barrier of reading paper patient decision aid. Next, based on the results of the pilot study, the modified Delphi method will be used to collect the opinions of experts, and the situational learning theory will be integrated into the patient decision aid to develop the web-based situation renal replacement therapies patient decision aid. After completion, investigators will apply quasi-experimental, a repeated measurement that will be adopted to analyze the effectiveness of web-based patient decision aid of renal replacement therapy in shared decision-making in patients with end-stage renal disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 406040
        • Recruiting
        • China Medical University
        • Contact:
        • Principal Investigator:
          • Ya-Fang Ho, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed by nephrologists as patients with chronic kidney disease, and GFR <30 ml/min/1.73m2.
  • As a patient admitted to the "Pre-ESRD care plan".
  • Clear awareness, ability to communicate in Mandarin and Taiwanese, and agree to participate in the research.
  • Those who are unable to answer the questions without other serious diseases or diseases affecting the mind.

Exclusion Criteria:

  • Those who cannot freely choose hemodialysis or peritoneal dialysis due to absolute contraindications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Written health education leaflets
Using written health education leaflets to conduct education.
Other: Written health education leaflets
After the clinic, use a written health education leaflet on renal replacement therapy to conduct education.
Experimental: Web-based patient decision aid
Using web-based patient decision aid of renal replacement therapy.
Other: Web-based patient decision aid
After the clinic, use web-based patient decision aid of renal replacement therapy to conduct education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes to the Preparation for Decision Making Scale (PrepDMS)
Time Frame: Baseline and immediately post-intervention.
The PrepDMS is a self-reported instrument assessing perceptions of usefulness in communicating health decisions. Possible scores range from 1(not at all) to 5 (a great deal). The higher the score, the higher the readiness for decision-making.
Baseline and immediately post-intervention.
Changes to the Decisional Conflict Scale (DCS)
Time Frame: Baseline, immediately post-intervention, and one-month post-intervention.
The DCS is a self-reported instrument assessing individual conflict and uncertainty about decision-making. Possible scores range from 0 (strongly agree) to 4 (strongly disagree). The higher the score, the higher the decisional conflict.
Baseline, immediately post-intervention, and one-month post-intervention.
Changes to the Decision Self Efficacy Scale (DSES)
Time Frame: Baseline, immediately post-intervention, and one-month post-intervention.
The DSES is a self-reported instrument assessing an individual's confidence or belief in their ability to make decisions. Possible scores range from 0 (not at all conflict) to 4 (very conflict). The higher the score, the higher the decision-making self-efficacy.
Baseline, immediately post-intervention, and one-month post-intervention.
Decision Regret Scale (DRS)
Time Frame: One-month post-intervention.
The DRS is a self-reported instrument measuring regret about health-related decisions. Possible scores range from 1 (strongly agree) to 5 (strongly disagree). Higher scores indicate higher decision-making regret.
One-month post-intervention.
Changes to the Renal Replacement Therapy Knowledge Scale (RRTKS)
Time Frame: Baseline and immediately post-intervention
The RRTKS is a self-reported instrument to assess knowledge of different treatment modalities. Scored as correct (1 point) and incorrect (0 points). Higher scores indicate higher knowledge of different treatment modalities.
Baseline and immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 18, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 18, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH109-REC3-085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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