End Stage Renal DiseaseNCT04108000
SPIRIT for Persons With Dementia and Complex Multimorbidity
A study testing SPIRIT-Dementia in people with End Stage Renal Disease, run by Emory University at 4 sites in United States.
Trial summary
In this study, 30 patient and caregiver dyads will be randomized to receive the SPIRIT-dementia intervention or usual care. Participants will be follow-up with 2-3 days after the intervention to evaluate the impact of SPIRIT on preparedness outcomes. Additional follow up with caregivers will occur 6 months later. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- SPIRIT-Dementia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Feb 2020to 23 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- lack of an available surrogate
- uncompensated hearing deficits
- already enrolled in hospice
- Surrogate Inclusion Criteria:
- 18 years or older
- be chosen by the patient
- able to understand and speak English
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory Dialysis at Northside
Atlanta, Georgia, 30318
Emory Dialysis at Greenbriar
Atlanta, Georgia, 30331
Emory Dialysis at North Decatur
Decatur, Georgia, 30033
Emory Dialysis at Candler
Decatur, Georgia, 30034
About this study
In this study, 30 patient and caregiver dyads will be randomized to receive the SPIRIT-dementia intervention or usual care. Participants will be follow-up with 2-3 days after the intervention to evaluate the impact of SPIRIT on preparedness outcomes. Additional follow up with caregivers will occur 6 months later.
Read the detailed description
Cognitive impairment or dementia, usually vascular dementia or Alzheimer's, co-occur in approximately 38% of patients with end stage renal disease (ESRD). When dementia is superimposed on ESRD, the risk for poor outcomes, including disability, hospitalization and death, sharply increases. Similarly, initiating dialysis in older adults with multiple comorbidities, including dementia, does not offer survival benefit. However, advance care planning (ACP) discussions with dialysis patients rarely occur. The reality of ESRD plus dementia is that most of these patients are likely to die or progress to advanced dementia without ever engaging in ACP discussions before the cognitive window of opportunity closes. Moreover, persons with dementia (regardless of their cognitive impairment level) are routinely excluded from clinical trials of ACP, largely because investigators assume that these people do not have the cognitive capability to appreciate the complexity of ACP. In an on-going study ("SPIRIT in Dementia") the researchers carefully adapted SPIRIT for persons with mild to moderate dementia (mostly due to Alzheimer's) and their surrogates. In a sample of 23 dementia patients without complex multimorbidity and their surrogates, the researchers were able to conclude that meaningful ACP conversations were possible even for individuals with moderate dementia. Based on these findings, this supplement study will leverage the infrastructure of the parent SPIRIT in ESRD trial to pilot test the adapted SPIRIT intervention for patients with ESRD plus dementia as a model for determining whether patients with dementia superimposed on complex multimorbidity can fully participate in ACP discussion.
This purpose of this pilot randomized controlled trial with 30 patient and caregiver dyads is to:
- estimate the effects of the SPIRIT-dementia intervention on: (a) preparedness outcomes for end-of-life decision making (defined as dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) 2-3 days post-intervention, and (b) care decisions (withdrawal from dialysis, Do-Not-Resuscitate order, hospice enrollment) assessed at 6 months post-intervention, or the patient's death, whichever occurs first,
- estimate the effects of the SPIRIT-dementia intervention on surrogates' post-bereavement distress (anxiety and depression symptoms) at 1 month after the patient's death, and
- explore the relationships among patients' cognitive status, decision-making capacity and their ability to express end-of-life wishes.
- Conditions
- End Stage Renal Disease
- Being tested
- SPIRIT-Dementia, Usual Care
- Keywords
- Dementia, Nursing, Nephrology, Behavioral research, Social research
- Medical subject headings
- Kidney Failure, Chronic, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIRIT-DementiaBehavioural
The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care.
Usual CareBehavioural
As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive.
| Study group | Role | What they receive |
|---|---|---|
| SPIRIT-Dementia | Experimental | Patients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention. Receives: Behavioral: SPIRIT-Dementia |
| Usual Care | Active comparator | Patients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyad Congruence
Dyad congruence will be assessed using the Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in ESRD patients. Possible responses to the scenarios are: "The goals of care should focus on delaying my death, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment, including dialysis", and "I am not sure". Patients and surrogates complete this tool independently and their responses are then compared to determine dyad congruence.
Measured: Baseline, 2 Days Post-intervention
Patient's Decisional Conflict Scale (DCS) Score
Patient decisional conflict will be measured using the 13-item Decisional Conflict Scale (DCS), a validated measure in the context of end-of-life decision making. Participants indicate their level of agreement with statements about their plans for their future medical care by selecting (1) Strongly Agree, (2) Agree, (3) Neither Agree nor Disagree, (4) Disagree, or (5) Strongly Disagree. The total score ranges from 13 - 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making.
Measured: Baseline, 2 Days Post-intervention
Surrogate's Decision Making Confidence (DMC) Scale Score
Surrogate decision-making confidence will be measured using the 5-item Decision Making Confidence (DMC) scale. Surrogates indicate how confident they are about making medical decisions if the patient becomes unable to make their own decisions by their level of agreement with statements along a scale of (0) "Not confident at all" to (5) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence.
Measured: Baseline, 2 Days Post-intervention
Secondary outcomes (3)
Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)
The proportion of decisions (participants who withdrew from dialysis, Do not resuscitate (DNR), or chose hospice enrollment) will be compared between study arms.
Measured: 6 and 12 Months Post-intervention
Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score
Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). The separate anxiety and depression subscale scores range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates "normal", 8-10 indicates "borderline abnormal", and 11-21 indicates "abnormal" levels of anxiety or depression.
Measured: Baseline, 1 Month after the Patient's Death
Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score
Surrogate post-bereavement anxiety and depressive symptoms will be measured with the Hospital Anxiety and Depression Scale (HADS). Surrogates indicate their level of agreement with statements by selecting responses rated from 0 (the problem in the statement is not an issue) to 3 (the problem in the statement is a very big issue). The separate anxiety and depression subscale scores range from 0 to 21 with higher scores indicating greater symptom severity. A score of 0-7 indicates "normal", 8-10 indicates "borderline abnormal", and 11-21 indicates "abnormal" levels of anxiety or depression.
Measured: Baseline, 1 Month after the Patient's Death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start14 Feb 2020
- Primary completion24 Mar 2022
- Study completion23 Mar 2023
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.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- 30 pairs of patients and their caregivers (surrogates) will be randomized to either receive the SPIRIT intervention or standard of care.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mi-Kyung Song, Emory University
- Investigators
- Mi-Kyung Song, RN, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108000
- Sponsor's protocol ID
- IRB00094859a
- Other IDs
- 3R01NR017018, 5R01AG057714
- Status last verified
- Apr 2023
- First submitted
- 26 Sep 2019
- Last updated
- 24 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIRIT for Persons With Dementia and Complex Multimorbidity
- ClinicalTrials.gov ID
- NCT04108000
- Acronym / sponsor ID
- IRB00094859a
- Conditions
- End Stage Renal Disease
- Keywords
- Dementia, Nursing, Nephrology, Behavioral research, Social research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institute on Aging (NIA)
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Posted 24 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, 30 patient and caregiver dyads will be randomized to receive the SPIRIT-dementia intervention or usual care. Participants will be follow-up with 2-3 days after the intervention to evaluate the impact of SPIRIT on preparedness outcomes. Additional follow up with caregivers will occur 6 months later.
Detailed description
Cognitive impairment or dementia, usually vascular dementia or Alzheimer's, co-occur in approximately 38% of patients with end stage renal disease (ESRD). When dementia is superimposed on ESRD, the risk for poor outcomes, including disability, hospitalization and death, sharply increases. Similarly, initiating dialysis in older adults with multiple comorbidities, including dementia, does not offer survival benefit. However, advance care planning (ACP) discussions with dialysis patients rarely occur. The reality of ESRD plus dementia is that most of these patients are likely to die or progress to advanced dementia without ever engaging in ACP discussions before the cognitive window of opportunity closes. Moreover, persons with dementia (regardless of their cognitive impairment level) are routinely excluded from clinical trials of ACP, largely because investigators assume that these people do not have the cognitive capability to appreciate the complexity of ACP. In an on-going study ("SPIRIT in Dementia") the researchers carefully adapted SPIRIT for persons with mild to moderate dementia (mostly due to Alzheimer's) and their surrogates. In a sample of 23 dementia patients without complex multimorbidity and their surrogates, the researchers were able to conclude that meaningful ACP conversations were possible even for individuals with moderate dementia. Based on these findings, this supplement study will leverage the infrastructure of the parent SPIRIT in ESRD trial to pilot test the adapted SPIRIT intervention for patients with ESRD plus dementia as a model for determining whether patients with dementia superimposed on complex multimorbidity can fully participate in ACP discussion.
This purpose of this pilot randomized controlled trial with 30 patient and caregiver dyads is to:
- estimate the effects of the SPIRIT-dementia intervention on: (a) preparedness outcomes for end-of-life decision making (defined as dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) 2-3 days post-intervention, and (b) care decisions (withdrawal from dialysis, Do-Not-Resuscitate order, hospice enrollment) assessed at 6 months post-intervention, or the patient's death, whichever occurs first,
- estimate the effects of the SPIRIT-dementia intervention on surrogates' post-bereavement distress (anxiety and depression symptoms) at 1 month after the patient's death, and
- explore the relationships among patients' cognitive status, decision-making capacity and their ability to express end-of-life wishes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 pairs of patients and their caregivers (surrogates) will be randomized to either receive the SPIRIT intervention or standard of care.
| Arm | Type | Receives |
|---|---|---|
| SPIRIT-Dementia | Experimental | Behavioral: SPIRIT-DementiaPatients and their surrogates randomized to this study arm will receive the SPIRIT-dementia intervention. |
| Usual Care | Active comparator | Behavioral: Usual CarePatients and surrogates randomized to this study arm will receive the standard information about advance directives that is provided at the time of diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- lack of an available surrogate
- uncompensated hearing deficits
- already enrolled in hospice
- 18 years or older
- be chosen by the patient
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 |
|---|---|---|
| SPIRIT-DementiaThe interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates "enhanced consent techniques," such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care. | Behavioural | SPIRIT-Dementia |
| Usual CareAs required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive. | Behavioural | Usual Care |
Primary outcome
Dyad Congruence
Time frame: Baseline, 2 Days Post-intervention
Dyad congruence will be assessed using the Goals-of-Care Tool which includes two scenarios describing medical conditions commonly occurring in ESRD patients. Possible responses to the scenarios are: "The goals of care should focus on delaying my death, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment, including dialysis", and "I am not sure". Patients and surrogates complete this tool independently and their responses are then compared to determine dyad congruence.
Patient's Decisional Conflict Scale (DCS) Score
Time frame: Baseline, 2 Days Post-intervention
Patient decisional conflict will be measured using the 13-item Decisional Conflict Scale (DCS), a validated measure in the context of end-of-life decision making. Participants indicate their level of agreement with statements about their plans for their future medical care by selecting (1) Strongly Agree, (2) Agree, (3) Neither Agree nor Disagree, (4) Disagree, or (5) Strongly Disagree. The total score ranges from 13 - 65 with higher scores indicating greater difficulty in weighing benefits and burdens of life-sustaining treatments and decision making.
Surrogate's Decision Making Confidence (DMC) Scale Score
Time frame: Baseline, 2 Days Post-intervention
Surrogate decision-making confidence will be measured using the 5-item Decision Making Confidence (DMC) scale. Surrogates indicate how confident they are about making medical decisions if the patient becomes unable to make their own decisions by their level of agreement with statements along a scale of (0) "Not confident at all" to (5) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence.
3 secondary outcomes
Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment)
Time frame: 6 and 12 Months Post-intervention
Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline, 1 Month after the Patient's Death
Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline, 1 Month after the Patient's Death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Mi-Kyung Song, RN, PhD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIRIT-Dementia in people with End Stage Renal Disease, run by Emory University at 4 sites in United States.
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 0 inclusion and 7 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 24 May 2023). 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?
Dyad Congruence (time frame: Baseline, 2 Days Post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2023.