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Renal Replacement Therapies Decision Aids

Primary Purpose

End-stage Renal Disease, Renal Replacement Therapy, Decision Aid

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Web-based patient decision aid
Written health education leaflets
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End-stage Renal Disease focused on measuring End-stage Renal Disease, Renal Replacement Therapy, Patient Decision Aid, Shared Decision-Making

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Written health education leaflets

Web-based patient decision aid

Arm Description

Using written health education leaflets to conduct education.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2022
Last Updated
December 18, 2022
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05666544
Brief Title
Renal Replacement Therapies Decision Aids
Official Title
Developing and Effectiveness Evaluation of Web-based Situation Renal Replacement Therapies Patient Decision Aids
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Written health education leaflets
Arm Type
Active Comparator
Arm Description
Using written health education leaflets to conduct education.
Arm Title
Web-based patient decision aid
Arm Type
Experimental
Arm Description
Using web-based patient decision aid of renal replacement therapy.
Intervention Type
Other
Intervention Name(s)
Web-based patient decision aid
Intervention Description
After the clinic, use web-based patient decision aid of renal replacement therapy to conduct education.
Intervention Type
Other
Intervention Name(s)
Written health education leaflets
Intervention Description
After the clinic, use a written health education leaflet on renal replacement therapy to conduct education.
Primary Outcome Measure Information:
Title
Changes to the Preparation for Decision Making Scale (PrepDMS)
Description
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.
Time Frame
Baseline and immediately post-intervention.
Title
Changes to the Decisional Conflict Scale (DCS)
Description
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.
Time Frame
Baseline, immediately post-intervention, and one-month post-intervention.
Title
Changes to the Decision Self Efficacy Scale (DSES)
Description
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.
Time Frame
Baseline, immediately post-intervention, and one-month post-intervention.
Title
Decision Regret Scale (DRS)
Description
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.
Time Frame
One-month post-intervention.
Title
Changes to the Renal Replacement Therapy Knowledge Scale (RRTKS)
Description
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.
Time Frame
Baseline and immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Fang Ho, PhD
Phone
886- 4-22967979
Ext
7108
Email
avonho97@mail.cmu.edu.tw
Facility Information:
Facility Name
China Medical University
City
Taichung
ZIP/Postal Code
406040
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya-Fang Ho, PhD
Phone
886- 4-22967979
Ext
7108
Email
avonho97@mail.cmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Ya-Fang Ho, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28212179
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.
Results Reference
background
PubMed Identifier
24731616
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.
Results Reference
background
PubMed Identifier
26762150
Citation
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.
Results Reference
result
PubMed Identifier
26567256
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. doi: 10.1136/bmjopen-2015-009116.
Results Reference
result

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Renal Replacement Therapies Decision Aids

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