Renal Replacement Therapies Decision Aids

NCT05666544 | Unknown

• 1 other identifier: CMUH109-REC3-085
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Written health education leaflets

ACTIVE COMPARATOR

Using written health education leaflets to conduct education.

Other: Written health education leaflets

Web-based patient decision aid

EXPERIMENTAL

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

Other: Web-based patient decision aid

Interventions

Web-based patient decision aid OTHER

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

Web-based patient decision aid

Written health education leaflets OTHER

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

Written health education leaflets

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, 406040, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 28212179 BACKGROUND

• 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.

  PMID: 24731616 BACKGROUND

• 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.

  PMID: 26762150 RESULT

• 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.

  PMID: 26567256 RESULT

• 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.

  PMID: 40177120 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ya-Fang Ho, PhD

CONTACT

886- 4-22967979; avonho97@mail.cmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 28, 2022
• Study Start: December 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)