Renal Replacement Therapies Decision Aids

NCT ID: NCT05666544

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-08-01

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.

Conditions

End-stage Renal Disease; Renal Replacement Therapy; Decision Aid; Decision-making

Keywords

End-stage Renal Disease; Renal Replacement Therapy; Patient Decision Aid; Shared Decision-Making

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Written health education leaflets

Using written health education leaflets to conduct education.

Group Type: ACTIVE_COMPARATOR

Written health education leaflets

Intervention Type: OTHER

After the clinic, use a written health education leaflet on renal replacement therapy to conduct education.

Web-based patient decision aid

Using web-based patient decision aid of renal replacement therapy.

Group Type: EXPERIMENTAL

Web-based patient decision aid

Intervention Type: OTHER

After the clinic, use web-based patient decision aid of renal replacement therapy to conduct education.

Interventions

Web-based patient decision aid

After the clinic, use web-based patient decision aid of renal replacement therapy to conduct education.

Intervention Type: OTHER

Written health education leaflets

After the clinic, use a written health education leaflet on renal replacement therapy to conduct education.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ya-Fang Ho, PhD

Role: CONTACT

Phone: 886- 4-22967979

Email: avonho97@mail.cmu.edu.tw

Facility Contacts

Ya-Fang Ho, PhD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 28212179 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24731616 (View on PubMed)

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: 10.1186/s12913-016-1262-4.

Reference Type: RESULT

PMID: 26762150 (View on PubMed)

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. doi: 10.1136/bmjopen-2015-009116.

Reference Type: RESULT

PMID: 26567256 (View on PubMed)

Su JM, Kuo HL, Yang KL, Wu CJ, Ho YF. Interactive decision aid on therapy decision making for patients with chronic kidney disease: A prospective exploratory pilot study. Digit Health. 2025 Apr 1;11:20552076251332832. doi: 10.1177/20552076251332832. eCollection 2025 Jan-Dec.

Reference Type: DERIVED

PMID: 40177120 (View on PubMed)

Other Identifiers

CMUH109-REC3-085

Identifier Type: -

Identifier Source: org_study_id