Palliative Care Information for Multiple Sclerosis

Recruiting at 1 trial location

Overseen By Aliza Ben-Zacharia, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hunter College of City University of New York

Disqualifiers: Visual impairment, Major depressive disorder, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different methods of sharing palliative care information affect decision-making for people with multiple sclerosis or similar conditions. Participants will either watch a short video or read written materials about palliative care to better understand their health options and express their care preferences. The study examines how the video might aid in making informed choices and fostering discussions about care plans. This trial suits individuals who have had multiple sclerosis or a similar condition for at least two years and are comfortable discussing their care. As an unphased trial, it offers a unique opportunity to contribute to understanding how information delivery can improve care decisions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing information and support for decision-making in palliative care, so it's unlikely that medication changes are required.

What prior data suggests that this palliative care model is safe?

Research shows that palliative care (PC) treatments, like the one under study, are generally safe and well-tolerated. Studies have found that these treatments can enhance care quality for people with multiple sclerosis (MS) without causing significant side effects. Specifically, advance care planning (ACP), a key component of this treatment, has led to better care outcomes and is safe for patients with serious illnesses. Overall, using palliative care methods in MS has not been linked to harmful effects, making it a safe choice for patients considering clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance palliative care for individuals with multiple sclerosis (MS). Unlike traditional approaches that primarily rely on written materials about palliative care and advance directives, this trial introduces a video-based intervention. This video offers a more engaging and informative experience, potentially improving patients' understanding and decision-making about their care. By comparing the impact of the video with standard written materials, researchers hope to find out if this method can lead to better patient outcomes and more effective advance care planning.

What evidence suggests that this trial's palliative care models could be effective for multiple sclerosis?

Research has shown that palliative care can benefit people with multiple sclerosis (MS). This trial will compare two approaches: the control arm, which follows standard palliative care with written materials, and the intervention group, which includes a palliative care video discussing advanced care planning. Studies have found that adding palliative care might improve life quality for those with severe MS. Early results suggest that decision aids, like videos, can help patients make better choices about their care. Patients using these tools often feel more prepared and have less difficulty deciding on health matters. While the impact on life quality is still under study, these methods aim to ensure care aligns with patients' values and preferences. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with neuroinflammatory diseases like Multiple Sclerosis. Participants should be able to understand content at a 7th or 8th grade reading level. The study aims to include a balanced representation of gender, ethnicity, and race.

Inclusion Criteria

I was diagnosed with MS, NMOSD, or anti-MOG over 2 years ago.

Exclusion Criteria

Visually impaired (note, hearing impaired is not an exclusion criterion as the video is closed captioned)

Psychological state not appropriate for PC discussions as determined by the Patient Health Questionnaire 9 (PHQ9)

A score of 11 or higher, indicative of major depressive disorder, will be referred to immediate management and excluded from the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete demographic forms and pre-tests

1 week

1 visit (in-person)

Intervention

Participants are randomized to either view a palliative care video or read written information, followed by post-tests

1 week

1 visit (in-person)

Follow-up

Participants are contacted by telephone to reassess goals-of-care preferences and complete post-tests

3 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Palliative Care Model

Trial Overview The trial tests two methods of delivering palliative care information: one group watches a video decision aid about goals of care, while the control group reads written material on the same topic. Both groups fill out questionnaires before and after three months.

How Is the Trial Designed?

Group I: Control arm Active Control 1 Intervention

The control arm will follow standard of care which comprises palliative care (PC)written material about the PC conversation and advance directives.

Group II: Intervention group Active Control 1 Intervention

The intervention group wil view a palliative care (PC) video discussing the PC conservation and advanced care planning (ACP).

Who Is Running the Clinical Trial?

Hunter College of City University of New York

Lead Sponsor

Trials

43

Recruited

10,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

A pilot palliative care counseling hotline for severely affected multiple sclerosis patients received 18 calls in its first year, with 10 callers qualifying for palliative care services based on their medical and caregiving needs.

The study indicates that the hotline is a valuable resource for connecting patients and caregivers to palliative care, and plans are in place to expand the service nationwide to better support more individuals in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A palliative care hotline for multiple sclerosis: A pilot feasibility study. Knies, AK., Golla, H., Strupp, J., et al.[2018]

The guideline developed for palliative care in patients with severe, progressive multiple sclerosis (MS) includes 34 recommendations, emphasizing the need for home-based palliative care to address the complex needs of these patients.

There is a significant lack of evidence regarding effective interventions for symptom management and caregiver support in this population, highlighting the need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EAN Guideline on Palliative Care of People with Severe, Progressive Multiple Sclerosis. Solari, A., Giordano, A., Sastre-Garriga, J., et al.[2023]

The guideline developed for palliative care in patients with severe, progressive multiple sclerosis (MS) includes 34 recommendations, emphasizing the need for home-based palliative care to address the complex needs of these patients.

There is a significant lack of evidence regarding effective interventions for symptom management and caregiver support in this population, highlighting the need for further research in integrating palliative care with MS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EAN guideline on palliative care of people with severe, progressive multiple sclerosis. Solari, A., Giordano, A., Sastre-Garriga, J., et al.[2021]

Palliative care for Multiple Sclerosis (MS) focuses on managing symptoms and providing psychosocial support, which significantly enhances the quality of life for patients.

Disease-modifying agents like interferon beta, Glatiramer acetate, and Mitoxantrone are essential in treating MS, but effective symptom relief and counseling are equally important for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care in patients with multiple sclerosis. Ben-Zacharia, AB., Lublin, FD.[2019]

A home-based palliative approach (HPA) for adults with severe multiple sclerosis (MS) was found to significantly reduce symptom burden compared to usual care, with effect sizes of 0.20 at 3 months and 0.32 at 6 months based on the Palliative care Outcome Scale-Symptoms-MS.

However, the HPA did not show a significant impact on the quality of life or other secondary outcomes for patients and their carers, indicating that while symptom relief was achieved, overall quality of life improvements were not evident.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a home-based palliative approach for people with severe multiple sclerosis. Solari, A., Giordano, A., Patti, F., et al.[2019]

This study is evaluating the effectiveness of a home-based palliative approach (HPA) for 75 patients with severe multiple sclerosis and their caregivers, comparing it to usual care over a six-month period.

The primary outcomes being measured include changes in symptoms and quality of life, which will help determine if the HPA provides significant benefits for both patients and their caregivers compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial. Solari, A., Giordano, A., Grasso, MG., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19833477/

Is short-term palliative care cost-effective in multiple ... The trial suggests that short-term palliative care for people severely affected by MS and their caregivers will be cost-effective and warrants further study.

2. jpsmjournal.com jpsmjournal.com/article/S0885-3924(24)00009-5/fulltext

Palliative Care Aspects in Multiple Sclerosis A systematic review aimed to evaluate the effects of palliative care interventions for MS patients showed uncertain effects on quality of life, ...

3. apm.amegroups.org apm.amegroups.org/article/view/122854/html

Integrating palliative care in patients with advanced multiple ... This study aims to describe what is known about the integration of palliative care (PC) in patients with severe MS (cost-effectiveness, moment of reference, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00364936

Development and Evaluation of a New Palliative Care ... The investigators modelled a new palliative care and neurology service for patients affected by Multiple Sclerosis (MS) by conducting qualitative interviews ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0885392409007416

Is Short-Term Palliative Care Cost-Effective in Multiple ... The trial suggests that short-term palliative care for people severely affected by MS and their caregivers will be cost-effective and warrants further study.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6803560/

Palliative care interventions for people with multiple sclerosis To assess the effects (benefits and harms) of palliative care interventions compared to usual care for people with any form of multiple sclerosis.

7. mdpi.com mdpi.com/2227-9032/12/20/2024

Determining the Need for Palliative Care Patients with ... Results: The need for palliative care was expressed by 36.7% of patients, who expressed the most concern for the physical symptoms, independence ...

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0695-0

Home-based palliative approach for people with severe ... The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers.