Two-Phased Study of SPIRIT in Mild Dementia

  • End date
    May 31, 2022
  • participants needed
  • sponsor
    Emory University
Updated on 25 January 2021
mini-mental state examination
mental state examination
moderate dementia
mild dementia
cognitive assessment


The proposed study will adapt and pilot test an efficacious advance care planning interventions, SPIRIT (Sharing Patient's Illness Representations to Increase Trust), with patients with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible.

The study includes two phases: Phase I to adapt, pretest, and refine SPIRIT, and Phase II to pilot test the refined SPIRIT to formally evaluate its feasibility, acceptability, and preliminary efficacy. The final products will be the modified SPIRIT intervention that improves dementia patient and surrogate outcomes, and standardized intervention manuals, including the SPIRIT Interview Guide, fidelity assessment, and training materials.

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.


Progressive memory loss and impairment of reasoning and judgment are the main symptoms of dementia (including Alzheimer's Disease). For this reason, people in the early stages of dementia are encouraged to engage in advance care planning (ACP) while they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions with the surrogate.

The most common type of ACP is completing a medical power of attorney or living will, which does not require the patient and/or the family to understand the complexity of the medical decision-making process faced by the surrogate as the patient progresses to advanced disease. The failure to engage in ACP before the window of opportunity closes (i.e., before loss of decision making capacity) has serious adverse consequences with the greatest impact on the surrogate. As a matter of course in dementia, family members are left to make decisions regarding care transition, tube feeding, and other life-sustaining treatment without input from the patient and in the absence of a full understanding of the wishes, values and preferences of the patient.

To make an impact on the state of ACP for patients with dementia and their surrogates, the researchers will adapt and pilot test an efficacious ACP intervention, SPIRIT (Sharing Patient's Illness Representations to Increase Trust), with patients with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. SPIRIT is a brief, scalable patient- and family-centered ACP intervention based on the Representational Approach to Patient Education with a goal to promote cognitive and emotional preparation for end-of-life decision making for patients with a serious or life-threatening illness and their surrogates. SPIRIT focuses on having both the patient and the surrogate fully understand end-of-life decision making in anticipation of a loss of decision-making capacity.

During Phase I of the study, a panel of seven experts will provide feedback on adapting SPIRIT to persons with dementia and their surrogates. SPIRIT will also be adapted to a video conference format so that patients and surrogates can receive the intervention in their home. To pretest the adapted SPIRIT intervention, the first 10 patient and surrogate dyads will be randomly assigned to SPIRIT-in person or to SPIRIT-remote. After completion of each session the interventionist will make field notes to document what did or did not go well, reasons for interruptions or difficulties, and contextual factors that cannot be captured in the audio-recording. During the post-intervention assessment each participant will complete the preparedness outcome questionnaires and will be asked about the overall experience with SPIRIT, any facets of the intervention that the participant found helpful or not helpful and the reasons (pacing, length, and modality), and suggestions for improvement. The researchers will alter or refine the intervention before pretesting a second set of 10 dyads.

Phase II of the study is a randomized clinical trial with three groups: SPIRIT-in person, SPIRIT-remote, and usual care. The researchers will recruit 120 dyads of patients with mild dementia and their surrogates. The groups will be stratified by race (white vs non-white). The primary outcomes are patient and surrogate self-reported preparedness for end-of-life decision making which will be measured at baseline and shortly after the intervention (by phone in the next 2-3 days). Additionally, the researchers will compare the completion rates of advance directives among the three groups and the impact of the three treatment conditions perceived by surrogates at 1-year post intervention.

As of July 2020, recruitment of Phase II participants into the SPIRIT-in person study arm ceased in consideration of social distancing guidelines due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Participants enrolled after this date will will be randomized to the SPIRIT-remote or usual care study arms.

Condition Dementia, Alzheimer's Disease, Alzheimer Disease and Related Dementias
Treatment Usual Care, SPIRIT-in person, SPIRIT-remote
Clinical Study IdentifierNCT03311711
SponsorEmory University
Last Modified on25 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Dementia or Alzheimer Disease and Related Dementias or Alzheimer's Disease?
Do you have any of these conditions: Alzheimer Disease and Related Dementias or Alzheimer's Disease or Dementia?
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

Inability to complete questionnaires due to physical or cognitive limitations
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