Renal Replacement Therapies Decision Aids

Not Applicable

Recruiting

• Conditions: Renal Replacement Therapy; Decision-making; Decision Aid; End-stage Renal Disease
• Interventions: Other: Written health education leaflets; Other: Web-based patient decision aid

• Registration Number: NCT05666544
• Lead Sponsor: China Medical University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-01
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-18
• Last Update Submitted: 2022-12-18
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28
• Primary Completion: 2023-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Written health education leaflets	Written health education leaflets	Using written health education leaflets to conduct education.
Web-based patient decision aid	Web-based patient decision aid	Using web-based patient decision aid of renal replacement therapy.

Primary Outcome Measures

Name	Time	Method
Changes to the Decisional Conflict Scale (DCS)	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.
Decision Regret Scale (DRS)	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.
Changes to the Preparation for Decision Making Scale (PrepDMS)	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.
Changes to the Renal Replacement Therapy Knowledge Scale (RRTKS)	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.
Changes to the Decision Self Efficacy Scale (DSES)	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.

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan