Renal Replacement Therapies Decision Aids

Sponsor
China Medical University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05666544
Collaborator
(none)
70
1
2
20
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Web-based patient decision aid
  • Other: Written health education leaflets
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Developing and Effectiveness Evaluation of Web-based Situation Renal Replacement Therapies Patient Decision Aids
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Written health education leaflets

Using written health education leaflets to conduct education.

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

Experimental: Web-based patient decision aid

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 China Medical University Taichung Taiwan 406040

Sponsors and Collaborators

  • China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT05666544
Other Study ID Numbers:
  • CMUH109-REC3-085
First Posted:
Dec 28, 2022
Last Update Posted:
Dec 28, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by China Medical University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2022