Kidney FailureDESIRENCT05842772
Feasibility Testing a shareD dEciSIon Making Intervention for People With Kidney failuRE, Their Relatives, and the Health Professionals in Kidney Services: a Pilot Randomized Controlled Trial Study Protocol
A study testing Shared decision making intervention for patients with kidney failure when planning end-of-life care in people with Kidney Failure and End of Life, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this research is to test the acceptability and feasibility of a shared decision making intervention and a patient decision aid to support patients with kidney failure, relatives, and health professionals in planning and deciding about end-of-life care together. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Kidney Failure, End of Life
- What is being tested?
- Shared decision making intervention for patients with kidney failure when planning end-of-life care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Mar 2023to 6 Oct 2023
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults with kidney failure on haemodialysis, peritoneal dialysis, or on conservative kidney management and their relatives will be considered for participation. Inclusion criteria will be adults ≥75 years of age, with an estimated glomerular filtration rate <15, and not suited for a kidney transplant.
Who cannot join
- Adults who are cognitively unable to participate will be excluded from the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Testing a shareD dEciSIon Making Intervention for People With Kidney failuRE (DESIRE), Their Relatives, and the Health Professionals in Kidney Services: a Pilot Randomized Controlled Trial Study Protocol
The aim of this research is to test the acceptability and feasibility of a shared decision making intervention and a patient decision aid to support patients with kidney failure, relatives, and health professionals in planning and deciding about end-of-life care together.
Read the detailed description
The objectives of this study is to pilot test an intervention aiming to accomplish shared decision making when deciding about end-of-life care preferences in people with kidney failure. The intervention consists of shared decision making consultations for adults with kidney failure their relatives and contact health professionals regarding end-of-life care planning supported by a patient decision aid. We will evaluate how adults, relatives and, health professionals implements the intervention and if the intervention is acceptable to the different stakeholders. The research question will investigate if the adults, relatives, and health professionals are experiencing the intervention as shared decision making and if they feel involved in the decision making process.
The DESIRE trial is designed as a pragmatic, pilot, randomized, controlled, non-blinded multicenter superiority trial with two parallel groups will test the acceptability and feasibility of the intervention on patients, relatives, and health professionals. Randomization will be performed as block randomization with a 1:1 allocation.
- Conditions
- Kidney Failure, End of Life
- Being tested
- Shared decision making intervention for patients with kidney failure when planning end-of-life care
- Keywords
- Shared decision making, Patient decision aid
- Medical subject headings
- Renal Insufficiency, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision making intervention for patients with kidney failure when planning end-of-life careOther
Testing a shared decision making intervention and a patient decision aid for patients with kidney failure, their relatives, and the health professionals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The DESIRE intervention which includes training of health professionals, a conversation with patients and their relatives, and a patient decision aid. Receives: Other: Shared decision making intervention for patients with kidney failure when planning end-of-life care |
| Control group | Active comparator | Usual care Receives: Other: Shared decision making intervention for patients with kidney failure when planning end-of-life care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the patient's palliative care needs
The primary outcome will be the change in the adults' palliative needs, as measured using the Integrated Palliative Outcome Score (IPOS)-Renal patient version questionnaire
Measured: Through study completion, an average of 6 months
Secondary outcomes (1)
Participants and relatives' experiences of shared decision making and health professionals' conduction of shared decision making are secondary outcomes.
Participants and relatives' experiences of shared decision making, as measured using the Patient Experience of Shared Decision Making (SHARED) tool and healthprofessionals' conduction of shared decision making, as measured using the Decision Support Analysis Tool (DSAT-10) are secondary outcomes.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start20 Mar 2023
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The DESIRE trial is designed as a pragmatic, pilot, randomized, controlled, non-blinded multicenter superiority trial with two parallel groups will test the acceptability and feasibility of the intervention on patients, relatives, and health professionals.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Engelbrecht Buur, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842772
- Sponsor's protocol ID
- PilotRCT_LEB
- Acronym
- DESIRE
- Status last verified
- Feb 2023
- First submitted
- 11 Apr 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buur LE, Bekker HL, Sondergaard H, Kannegaard M, Madsen JK, Khatir DS, Finderup J. Feasibility and acceptability of the ShareD dEciSIon making for patients with kidney failuRE to improve end-of-life care intervention: A pilot multicentre randomised controlled trial. Int J Nurs Stud Adv. 2024 Aug 5;7:100231. doi: 10.1016/j.ijnsa.2024.100231. eCollection 2024 Dec.
PubMed 39221228
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing a shareD dEciSIon Making Intervention for People With Kidney failuRE (DESIRE), Their Relatives, and the Health Professionals in Kidney Services: a Pilot Randomized Controlled Trial Study Protocol
- ClinicalTrials.gov ID
- NCT05842772
- Acronym / sponsor ID
- DESIRE / PilotRCT_LEB
- Conditions
- Kidney Failure, End of Life
- Keywords
- Shared decision making, Patient decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 6 May 2023 (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.
The aim of this research is to test the acceptability and feasibility of a shared decision making intervention and a patient decision aid to support patients with kidney failure, relatives, and health professionals in planning and deciding about end-of-life care together.
Detailed description
The objectives of this study is to pilot test an intervention aiming to accomplish shared decision making when deciding about end-of-life care preferences in people with kidney failure. The intervention consists of shared decision making consultations for adults with kidney failure their relatives and contact health professionals regarding end-of-life care planning supported by a patient decision aid. We will evaluate how adults, relatives and, health professionals implements the intervention and if the intervention is acceptable to the different stakeholders. The research question will investigate if the adults, relatives, and health professionals are experiencing the intervention as shared decision making and if they feel involved in the decision making process.
The DESIRE trial is designed as a pragmatic, pilot, randomized, controlled, non-blinded multicenter superiority trial with two parallel groups will test the acceptability and feasibility of the intervention on patients, relatives, and health professionals. Randomization will be performed as block randomization with a 1:1 allocation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The DESIRE trial is designed as a pragmatic, pilot, randomized, controlled, non-blinded multicenter superiority trial with two parallel groups will test the acceptability and feasibility of the intervention on patients, relatives, and health professionals.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Shared decision making intervention for patients with kidney failure when planning end-of-life careThe DESIRE intervention which includes training of health professionals, a conversation with patients and their relatives, and a patient decision aid. |
| Control group | Active comparator | Other: Shared decision making intervention for patients with kidney failure when planning end-of-life careUsual care |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Adults with kidney failure on haemodialysis, peritoneal dialysis, or on conservative kidney management and their relatives will be considered for participation. Inclusion criteria will be adults ≥75 years of age, with an estimated glomerular filtration rate <15, and not suited for a kidney transplant.
Key exclusion criteria (1 listed)
- Adults who are cognitively unable to participate will be excluded from the research.
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 |
|---|---|---|
| Shared decision making intervention for patients with kidney failure when planning end-of-life careTesting a shared decision making intervention and a patient decision aid for patients with kidney failure, their relatives, and the health professionals. | Other | Control group, Intervention group |
Primary outcome
change in the patient's palliative care needs
Time frame: Through study completion, an average of 6 months
The primary outcome will be the change in the adults' palliative needs, as measured using the Integrated Palliative Outcome Score (IPOS)-Renal patient version questionnaire
1 secondary outcome
Participants and relatives' experiences of shared decision making and health professionals' conduction of shared decision making are secondary outcomes.
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 39221228Buur LE, Bekker HL, Sondergaard H, Kannegaard M, Madsen JK, Khatir DS, Finderup J. Feasibility and acceptability of the ShareD dEciSIon making for patients with kidney failuRE to improve end-of-life care intervention: A pilot multicentre randomised controlled trial. Int J Nurs Stud Adv. 2024 Aug 5;7:100231. doi: 10.1016/j.ijnsa.2024.100231. eCollection 2024 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.
Louise Engelbrecht Buur principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision making intervention for patients with kidney failure when planning end-of-life care in people with Kidney Failure and End of Life, run by University of Aarhus at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 10 May 2024. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the patient's palliative care needs (time frame: Through study completion, an average of 6 months). 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 NCT05842772, which also lists 1 linked publication.
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 10 May 2024.