Kidney Failure, ChronicACREDiTNCT02631200
Advance Care Planning With Older Patients Who Have End-stage Kidney Disease
A study testing Advance care plan in people with Kidney Failure, Chronic, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
This study will test the feasibility of carrying out a randomised controlled trial, incorporating a mixed methods process evaluation, to evaluate advance care planning with older patients who have end-stage kidney disease. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Advance care plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Attending the renal units taking part in the study
- Receiving renal replacement therapy
- Capacity to understand, retain, and weigh the necessary information and communicate their decisions
- Identified by their consultant as having worsening symptoms, functional decline, and two or more co-morbidities.
Who cannot join
- Expected to die in the next three months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's University Belfast
Belfast, Northern Ireland, BT7 1NN
About this study
Official title: Advance Care Planning With Older Patients Who Have End-stage Kidney Disease: Feasibility of a Deferred Entry Randomised Controlled Trial Incorporating a Mixed Methods Process Evaluation
This study will test the feasibility of carrying out a randomised controlled trial, incorporating a mixed methods process evaluation, to evaluate advance care planning with older patients who have end-stage kidney disease.
Read the detailed description
Kidney failure becomes more common as people age. It increases the risks of other major illnesses, sudden worsening of symptoms, and death. Even so, many people with kidney failure do not talk about their preferences for end-of-life care.
Advance care planning (ACP) can help patients and families think through their preferences for future care and discuss these with the professionals looking after them. This may lead to care more in keeping with patients' wishes and so reduce distress for patients and families. ACP is recommended as good practice for people with kidney failure.
However, questions remain about the impact of ACP on patients and families; and also about the best ways to put ACP into practice. Doing research about ACP is challenging for everyone involved, so we need to thoroughly test our research methods in a pilot study before we attempt a larger study that would fully answer those questions.
To test our methods we will carry out a small-scale randomised controlled trial comparing those patients who use ACP with those who do not, in terms of: quality of life, anxiety, depression, physical functioning, well-being, satisfaction with decision-making and agreement between the patient and their nominated carer in terms of the patient's preferences for care at the end of life.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Advance care plan
- Keywords
- Advance Care Planning, Palliative care, Frail Elderly, Renal Dialysis
- 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.
Advance care planBehavioural
Participants will be offered the opportunity to complete an ACP by a nurse trained as an ACP facilitator, who will discuss the process with them using standard materials. At least 48 hours later, they will complete an ACP document with the help of the ACP facilitator, working together with trained expert patients who will provide peer support at the time of ACP completion and subsequently by telephone, assisted where necessary by the ACP facilitator.
| Study group | Role | What they receive |
|---|---|---|
| Advance care plan | Experimental | Participants will be offered the opportunity to complete an advance care plan. Receives: Behavioral: Advance care plan |
| Usual care | No intervention | Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney Disease Quality
Quality of life as measured by the Kidney Disease Quality of Life instrument - Short Form (KDQOL-36™). The KDQOL-36 has five scales, including two generic health related quality of life (HRQOL) scales from the Short-Form (SF)-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each scale has a minimum score of zero and a maximum of 100. Higher scores reflect better quality of life and a better outcome. Subscales are not combined.
Measured: 12 weeks post intervention
Secondary outcomes (3)
Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences
Number of Participants with Agreement between the patient and their nominated carer in terms of the patient's preferences. We will measure this by asking the carer to make an independent assessment of the patient's preferences in relation to the key information covered by the ACP intervention, before taking part in the ACP.
Measured: 12 weeks post intervention
Depression
Degree of anxiety, depression, well-being, functioning and risk as measured by the Clinical Outcomes in Routine Evaluation measure (CORE 34) a 34- item Likert-type scale scored on a 5-point scale ranging from 0 (not at all) to 4 (most or all the time). The minimum mean value is zero and the maximum is 4. Higher scores indicate greater distress and a worse outcome. Mean scores from reference groups are 1.86 (SD 0.75) for those referred to psychiatric services and 0.76 (SD 0.59) for the general population.
Measured: 12 weeks post intervention
The Degree to Which the Patient Felt That They Had Shared in Decision-making.
The degree to which the patient felt that they had shared in decision-making about their care as measured by the Patient Experience of Shared Decision Making (SHARED) instrument. This is a a ten-item Likert-type scale ranging from 'Disagree strongly' to 'Agree strongly', with one point for 'Agree', two for 'Agree strongly', and no points for disagreement. The minimum score is zero and the maximum is 20. Higher scores indicate more sharing and a better outcome.
Measured: 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2016
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- The Dunhill Medical Trust
- Responsible party
- Principal investigator, Peter O'Halloran, Queen's University, Belfast
- Investigators
- Peter D O'Halloran, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631200
- Sponsor's protocol ID
- 20724-1
- Acronym
- ACREDiT
- Status last verified
- Feb 2024
- First submitted
- 28 Oct 2015
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified data that underlie the results reported in this article are available to qualified researchers for approved scientific uses immediately following publication of the trial results\* with no end date. Data access proposals should be directed to the corresponding author. The Trial Protocol is available on request. \*DOI https://doi.org/10.1186/s12882-020-02129-5
Publications
O'Halloran P, Noble H, Norwood K, Maxwell P, Murtagh F, Shields J, Mullan R, Matthews M, Cardwell C, Clarke M, Morton R, Shah K, Forbes T, Brazil K. Nurse-led advance care planning with older people who have end-stage kidney disease: feasibility of a deferred entry randomised controlled trial incorporating an economic evaluation and mixed methods process evaluation (ACReDiT). BMC Nephrol. 2020 Nov 13;21(1):478. doi: 10.1186/s12882-020-02129-5.
PubMed 33187506
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advance Care Planning With Older Patients Who Have End-stage Kidney Disease: Feasibility of a Deferred Entry Randomised Controlled Trial Incorporating a Mixed Methods Process Evaluation
- ClinicalTrials.gov ID
- NCT02631200
- Acronym / sponsor ID
- ACREDiT / 20724-1
- Conditions
- Kidney Failure, Chronic
- Keywords
- Advance Care Planning, Palliative care, Frail Elderly, Renal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- The Dunhill Medical Trust
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the feasibility of carrying out a randomised controlled trial, incorporating a mixed methods process evaluation, to evaluate advance care planning with older patients who have end-stage kidney disease.
Detailed description
Kidney failure becomes more common as people age. It increases the risks of other major illnesses, sudden worsening of symptoms, and death. Even so, many people with kidney failure do not talk about their preferences for end-of-life care.
Advance care planning (ACP) can help patients and families think through their preferences for future care and discuss these with the professionals looking after them. This may lead to care more in keeping with patients' wishes and so reduce distress for patients and families. ACP is recommended as good practice for people with kidney failure.
However, questions remain about the impact of ACP on patients and families; and also about the best ways to put ACP into practice. Doing research about ACP is challenging for everyone involved, so we need to thoroughly test our research methods in a pilot study before we attempt a larger study that would fully answer those questions.
To test our methods we will carry out a small-scale randomised controlled trial comparing those patients who use ACP with those who do not, in terms of: quality of life, anxiety, depression, physical functioning, well-being, satisfaction with decision-making and agreement between the patient and their nominated carer in terms of the patient's preferences for care at the end of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advance care plan | Experimental | Behavioral: Advance care planParticipants will be offered the opportunity to complete an advance care plan. |
| Usual care | No intervention | –Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Attending the renal units taking part in the study
- Receiving renal replacement therapy
- Capacity to understand, retain, and weigh the necessary information and communicate their decisions
- Identified by their consultant as having worsening symptoms, functional decline, and two or more co-morbidities.
Key exclusion criteria (1 listed)
- Expected to die in the next three months
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 |
|---|---|---|
| Advance care planParticipants will be offered the opportunity to complete an ACP by a nurse trained as an ACP facilitator, who will discuss the process with them using standard materials. At least 48 hours later, they will complete an ACP document with the help of the ACP facilitator, working together with trained expert patients who will provide peer support at the time of ACP completion and subsequently by telephone, assisted where necessary by the ACP facilitator. | Behavioural | Advance care plan |
Primary outcome
Kidney Disease Quality
Time frame: 12 weeks post intervention
Quality of life as measured by the Kidney Disease Quality of Life instrument - Short Form (KDQOL-36™). The KDQOL-36 has five scales, including two generic health related quality of life (HRQOL) scales from the Short-Form (SF)-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each scale has a minimum score of zero and a maximum of 100. Higher scores reflect better quality of life and a better outcome. Subscales are not combined.
3 secondary outcomes
Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences
Time frame: 12 weeks post intervention
Depression
Time frame: 12 weeks post intervention
The Degree to Which the Patient Felt That They Had Shared in Decision-making.
Time frame: 12 weeks post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33187506O'Halloran P, Noble H, Norwood K, Maxwell P, Murtagh F, Shields J, Mullan R, Matthews M, Cardwell C, Clarke M, Morton R, Shah K, Forbes T, Brazil K. Nurse-led advance care planning with older people who have end-stage kidney disease: feasibility of a deferred entry randomised controlled trial incorporating an economic evaluation and mixed methods process evaluation (ACReDiT). BMC Nephrol. 2020 Nov 13;21(1):478. doi: 10.1186/s12882-020-02129-5.
- Individual participant dataSharing planned: Yes. Deidentified data that underlie the results reported in this article are available to qualified researchers for approved scientific uses immediately following publication of the trial results* with no end date. Data access proposals should be directed to the corresponding author. The Trial Protocol is available on request. *DOI https://doi.org/10.1186/s12882-020-02129-5
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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.
Peter D O'Halloran, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance care plan in people with Kidney Failure, Chronic, run by Queen's University, Belfast at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 29 Jul 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Kidney Disease Quality (time frame: 12 weeks post intervention). 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 NCT02631200, 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 29 Jul 2024.