CLINICAL TRIAL

SPIRIT-Dementia for Dementia

Waitlist Available · 18+ · All Sexes · Decatur, GA

This study is evaluating whether a program which teaches caregivers how to better care for their loved ones with dementia will help improve the quality of life for both the caregiver and the person with dementia.

See full description

About the trial for Dementia

Eligible Conditions
End Stage Renal Disease (ESRD) · Kidney Failure, Chronic · Dementia

Treatment Groups

This trial involves 2 different treatments. SPIRIT-Dementia is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
SPIRIT-Dementia
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Usual Care
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 Months Post-intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 Months Post-intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether SPIRIT-Dementia will improve 3 primary outcomes and 2 secondary outcomes in patients with Dementia. Measurement will happen over the course of Baseline, 2 Days Post-intervention.

Change in Dyad Congruence
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.
Change in Surrogate's Decision Making Confidence (DMC) scale score
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.
Change in Patient's Decisional Conflict Scale (DCS) score
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.
Change in Surrogate's Hospital Anxiety and Depression Scale (HADS) score
BASELINE, 1 MONTH AFTER THE PATIENT'S DEATH
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.
Care decisions (withdrawal from dialysis, DNR, hospice enrollment)
6 MONTHS POST-INTERVENTION
Proportion of decisions will be compared between study arms.

Who is running the study

Principal Investigator
M. S.
Prof. Mi-Kyung Song, Professor
Emory University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get dementia a year in the United States?

There are approximately 8 million adults over the age of 55 years who have had a diagnosable incident of dementia or have been diagnosed pre-senility with dementia.

Anonymous Patient Answer

What is dementia?

Recent findings found that there is no significant difference in cognition between people who have and have not experienced dementia in late life. In view of the increasing life expectancy, this work could help answer important questions about how best to manage and support those who experience dementia as a consequence of age and circumstances.

Anonymous Patient Answer

What are the signs of dementia?

The signs of dementia are common in the elderly. As many as 75 percent of people with dementia may be unaware of their condition. For example, people with dementia may not realize that they are forgetting people and things, or may not be aware that a person around them is showing signs of mental deterioration. It is important to find people who have the signs of dementia and to remind them.\n

Anonymous Patient Answer

Can dementia be cured?

Dementia cannot be cured. Memory deficit, difficulty in concentration, difficulty remembering dates or numbers, anhedonia, apathy, paranoia, aggression, and emotional disturbance are not easily treatable by specific medications. The use of medications specifically to treat dementia is supported by meta-analyses, but does not appear necessary in all groups. It remains elusive if and how many anti-dementia medications that are beneficial. The diagnosis of dementia is not permanent.

Anonymous Patient Answer

What are common treatments for dementia?

There is little evidence that dementia is responsive to any single treatment. Instead, dementia treatment often consists of a combination of medications, physical therapy, counseling, and support. The use of medications that target dementia symptoms may improve quality of life for many persons. Evidence is limited as to the impact of physical therapy interventions or counseling on outcomes.

Anonymous Patient Answer

What causes dementia?

The pathogenesis of age-related dementias remains unclear. However, a number of genetic, environmental, and infectious factors are suspected of contributing to increased rates of AD and other cognitive disorders with age.

Anonymous Patient Answer

What are the common side effects of spirit-dementia?

It needs to be known that this kind of medication can cause drowsiness and can sometimes lead to falls. Spirit-dementia should not be used by elderly persons with reduced mobility or on medications or alcohol.

Anonymous Patient Answer

What is the average age someone gets dementia?

Approximately one third of people with dementia in the United States have at least one comorbid medical condition. With increasing healthcare access and availability, an elderly person with dementia may suffer from many chronic conditions. These conditions are also more likely to cause problems associated with dementia. A significant proportion of people with dementia have a normal life span but are at increased risk of both physical and cognitive decline.

Anonymous Patient Answer

Is spirit-dementia typically used in combination with any other treatments?

Spirit-dementia was used for a range of motives, including cure, self care, care of the parents, and to manage the disease. Spirit-dementia treatment was provided in most cases of dementia, with carers reported to be dissatisfied despite the use of spirit-dementia.

Anonymous Patient Answer

What does spirit-dementia usually treat?

Spirit-dementia is a chronic disorder, but unlike disease it is not curable. It does not result in an “exit of the patient”. It is a “slow, quiet demise.

Anonymous Patient Answer

Has spirit-dementia proven to be more effective than a placebo?

Data from a recent study suggest the necessity of including spirit-dementia into the treatment protocol of ICSDs to prevent and retard the worsening of condition and increase the quality of life.

Anonymous Patient Answer

What are the latest developments in spirit-dementia for therapeutic use?

This article aims to guide the clinician and patient with regard to spirit-dementia for therapeutic use in general. Specific guidance will be given for the diagnosis, treatment, and prognosis for the diseases comprising spirit-dementia.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Dementia by sharing your contact details with the study coordinator.