End-stage Renal DiseaseNCT05666544
Renal Replacement Therapies Decision Aids
A study testing Web-based patient decision aid and Written health education leaflets in people with End-stage Renal Disease and Renal Replacement Therapy, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End-stage Renal Disease, Renal Replacement Therapy, Decision Aid
- What is being tested?
- Web-based patient decision aid and Written health education leaflets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those who cannot freely choose hemodialysis or peritoneal dialysis due to absolute contraindications.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University
Taichung, 406040
Ya-Fang Ho, PhD, 886- 4-22967979 ext. 7108, avonho97@mail.cmu.edu.tw
Ya-Fang Ho, PhD
About this study
Official title: Developing and Effectiveness Evaluation of Web-based Situation Renal Replacement Therapies Patient Decision Aids
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.
- Being tested
- Web-based patient decision aid, Written health education leaflets
- Keywords
- End-stage Renal Disease, Renal Replacement Therapy, Patient Decision Aid, Shared Decision-Making
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based patient decision aidOther
After the clinic, use web-based patient decision aid of renal replacement therapy to conduct education.
Written health education leafletsOther
After the clinic, use a written health education leaflet on renal replacement therapy to conduct education.
| Study group | Role | What they receive |
|---|---|---|
| Written health education leaflets | Active comparator | Using written health education leaflets to conduct education. Receives: Other: Written health education leaflets |
| Web-based patient decision aid | Experimental | Using web-based patient decision aid of renal replacement therapy. Receives: Other: Web-based patient decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Dec 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666544
- Sponsor's protocol ID
- CMUH109-REC3-085
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28212179Gionfriddo 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.
PubMed 24731616Bailey 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.
PubMed 26762150Buhse 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.
PubMed 26567256Su 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.
PubMed 40177120
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Effectiveness Evaluation of Web-based Situation Renal Replacement Therapies Patient Decision Aids
- ClinicalTrials.gov ID
- NCT05666544
- Acronym / sponsor ID
- CMUH109-REC3-085
- Keywords
- End-stage Renal Disease, Renal Replacement Therapy, Patient Decision Aid, Shared Decision-Making
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written health education leaflets | Active comparator | Other: Written health education leafletsUsing written health education leaflets to conduct education. |
| Web-based patient decision aid | Experimental | Other: Web-based patient decision aidUsing web-based patient decision aid of renal replacement therapy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who cannot freely choose hemodialysis or peritoneal dialysis due to absolute contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based patient decision aidAfter the clinic, use web-based patient decision aid of renal replacement therapy to conduct education. | Other | Web-based patient decision aid |
| Written health education leafletsAfter the clinic, use a written health education leaflet on renal replacement therapy to conduct education. | Other | Written health education leaflets |
Primary outcome
Changes to the Preparation for Decision Making Scale (PrepDMS)
Time frame: 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.
Changes to the Decisional Conflict Scale (DCS)
Time frame: 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.
Changes to the Decision Self Efficacy Scale (DSES)
Time frame: 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.
Decision Regret Scale (DRS)
Time frame: 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.
Changes to the Renal Replacement Therapy Knowledge Scale (RRTKS)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Background: PubMed 28212179Davis 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.
- Background: PubMed 24731616Gionfriddo 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 publication: PubMed 26762150Bailey 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 publication: PubMed 26567256Buhse 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.
- Derived from this study: PubMed 40177120Su 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based patient decision aid and Written health education leaflets in people with End-stage Renal Disease and Renal Replacement Therapy, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Fang Ho, PhD (886- 4-22967979 ext. 7108, avonho97@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes to the Preparation for Decision Making Scale (PrepDMS) (time frame: Baseline and immediately post-intervention.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05666544, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.