N/A
N=242
Preparation for End-of-Life Decision Making in Mild Dementia
Dementia
Bottom Line
View on ClinicalTrials.gov: NCT03311711 ↗Enrolled (actual)
242
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Dyad Congruence With Goals-of-Care Tool — 9; 4; 11; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPIRIT-in person (Behavioral); SPIRIT-remote (Behavioral); Usual care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dyad Congruence With Goals-of-Care Tool |
9; 4; 11; 24; 30; 6 | — |
| PRIMARY Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants |
18.40; 18.08; 18.20; 18.33; 18.10; 19.08 | — |
| PRIMARY Surrogate's Overall Preparedness Scale |
75.27; 75.75; 75.53; 72.15; 74.69; 83.75 | — |
| SECONDARY Completion of Advance Directives Among Phase II Participants |
10; 9; 14; 33; 30; 5 | — |
| SECONDARY Patient's Overall Preparedness Scale |
55.40; 54.67; 54.07; 54.90; 53.50; 57.83 | — |
Summary
The proposed study will adapt and pilot test an efficacious advance care planning interventions, Sharing Patient's Illness Representations to Increase Trust (SPIRIT), with patients with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. Patient and surrogate decision maker dyads will participate in a single SPIRIT session and will then have a follow up phone call 2-3 days later. One year after the SPIRIT session some surrogates will be contacted to provide additional feedback about the intervention.
Eligibility Criteria
Inclusion Criteria for Patients with Mild to Moderate Dementia:
- A diagnosis of mild to moderate dementia based on a Montreal Cognitive Assessment (MoCA) score greater than or equal to 13, or Mini-Mental State Examination (MMSE) score greater than or equal to 18
- Have access to a computer and internet connectivity in a private setting (either the patient or the surrogate has access to a computer and internet connectivity)
- Have decision-making capacity to consent to a low-risk study determined by a score greater than or equal to 11 on the University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
- Able to understand and speak English
Exclusion Criteria for Patients with Mild to Moderate dementia:
- Lack of an available surrogate
- Uncompensated hearing deficits
- Speech impairment
Inclusion Criteria for Surrogates:
- 18 years or older (to serve as a surrogate decision-maker, the individual must be an adult)
- Be chosen by the patient to serve as a surrogate decision-maker
- Have access to a computer and internet connectivity in a private setting (either the patient or the surrogate has access to a computer and internet connectivity)
- Able to understand and speak English
Exclusion Criteria for Surrogates:
- Inability to complete questionnaires due to physical or cognitive limitations
Data sourced from ClinicalTrials.gov (NCT03311711). 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.