Renal Replacement Therapies Decision Aids

Study Overview
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Brief Summary
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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.

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

Conditions
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End-stage Renal Disease, Renal Replacement Therapy, Decision Aid, Decision-making

Intervention / Treatment
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* Other: Web-based patient decision aid
* Other: Written health education leaflets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes to the Preparation for Decision Making Scale (PrepDMS) | 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-stage Renal Disease, Renal Replacement Therapy, Patient Decision Aid, Shared Decision-Making