Renal Replacement Therapies Decision Aids

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666544
• Other study ID #: CMUH109-REC3-085
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: December 2022
• Source: China Medical University Hospital
• Contact: Ya-Fang Ho, PhD
• Phone: 886- 4-22967979
• Email: avonho97[@]mail.cmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Decision Aid
• Decision-making
• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Replacement Therapy

Intervention

Other:
• Web-based patient decision aid
After the clinic, use web-based patient decision aid of renal replacement therapy to conduct education.
• Written health education leaflets
After the clinic, use a written health education leaflet on renal replacement therapy to conduct education.

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Bailey RA, Pfeifer M, Shillington AC, Harshaw Q, Funnell MM, VanWingen J, Col N. Effect of a patient decision aid (PDA) for type 2 diabetes on knowledge, decisional self-efficacy, and decisional conflict. BMC Health Serv Res. 2016 Jan 14;16:10. doi: 10.11 — View Citation

Buhse S, Muhlhauser I, Heller T, Kuniss N, Muller UA, Kasper J, Lehmann T, Lenz M. Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial. BMJ Open. 2015 Nov 13;5(11):e009116. — View Citation

Davis JL, Davison SN. Hard choices, better outcomes: a review of shared decision-making and patient decision aids around dialysis initiation and conservative kidney management. Curr Opin Nephrol Hypertens. 2017 May;26(3):205-213. doi: 10.1097/MNH.0000000000000321. — View Citation

Gionfriddo MR, Leppin AL, Brito JP, Leblanc A, Boehmer KR, Morris MA, Erwin PJ, Prokop LJ, Zeballos-Palacios CL, Malaga G, Miranda JJ, McLeod HM, Rodriguez-Gutierrez R, Huang R, Morey-Vargas OL, Murad MH, Montori VM. A systematic review of shared decision making interventions in chronic conditions: a review protocol. Syst Rev. 2014 Apr 15;3:38. doi: 10.1186/2046-4053-3-38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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