N/A
Completed N=38
SPIRIT for Persons With Dementia and Complex Multimorbidity
Source: ClinicalTrials.gov NCT04108000 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Dyad Congruence — 1; 5; 8; 5 Dyads
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dyad Congruence |
1; 5; 8; 5; 1; 4 | — |
| PRIMARY Patient's Decisional Conflict Scale (DCS) Score |
14.11; 16.00; 15.29; 16.67 | — |
| PRIMARY Surrogate's Decision Making Confidence (DMC) Scale Score |
18.44; 17.00; 17.57; 18.67 | — |
| SECONDARY Care Decisions (Withdrawal From Dialysis, DNR, Hospice Enrollment) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Surrogate's Anxiety-Score Using the Hospital Anxiety and Depression Scale (HADS) Score |
2.00; 4.00; 7.50 | — |
| SECONDARY Surrogate's Depression-Score by Using the Hospital Anxiety and Depression Scale (HADS) Score |
7.00; 7.00; 9.50 | — |
Eligibility Criteria
Patient Inclusion Criteria:
- receiving in-center hemodialysis
- diagnosed with dementia or having mild to moderate cognitive impairment based on a Montreal Cognitive Assessment (MoCA) score 13-25 or a Saint Louis University Mental Status (SLUMS) score < 27 (high school education) or < 25 (less than high school education)
- able to understand and speak English
- a University of California San Diego Brief Assessment of Capacity to Consent (UBACC) score of 11 or higher
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04108000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.