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Evaluation of Palliative Care for Patients With ALS and Their Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04257760
Recruitment Status : Active, not recruiting
First Posted : February 6, 2020
Last Update Posted : September 29, 2022
Sponsor:
Collaborator:
ALS Society of Canada
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
Rationale: Amyotrophic lateral sclerosis (ALS) is a degenerative illness which currently has no medical cure. It is routinely accompanied by a significant symptom burden including high levels of distress in patients and their caregivers. As a result, an early palliative care approach is recommended in the ALS population. Palliative care has been shown to have positive effects on the quality of life in patients and caregivers in other life limiting illness such as cancer and multiple sclerosis. Unfortunately, our understanding of the palliative care needs in ALS is limited and the efficacy of palliative care involvement is poorly understood. Furthermore, ALS patients are largely underserved by palliative care in Ontario, with <50% of ALS patients receiving palliative care even in the last year of life. Hypothesis: The investigators hypothesize that ALS patients will be agreeable to palliative care consultations and that this will improve the quality of life of patients and their caregivers. Specific Aims: This project seeks to initiate routine palliative care consultation in an interdisciplinary ALS clinic to: 1) improve patient and caregiver quality of life, 2) further understand the palliative care needs of the ALS population and 3) identify which patients and caregivers are most likely to benefit from palliative care consultation, thus guiding clinicians on when to refer in the future. Significance: This study is the first investigate the feasibility and efficacy of palliative care consultation in the ALS population, and its effects on quality of life. It has the potential to provide increased support to patients as well as caregivers. Finally, this study will aid in our understanding of the optimal time to involve palliative care in the ALS population and will act as a foundation on which larger, controlled studies can be built.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Behavioral: Palliative Care consultation outside standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It is a pilot trial to assess the feasibility of palliative care for ALS patients. Patients will be in the palliative care or non-palliative care arm of the trial based on their decision to have a palliative care consultation or not. If they do not initially chose a palliative care consult they can change their mind during the course of the trial.
Masking: None (Open Label)
Masking Description: The patients, the palliative care physicians and the research team will know if a palliative care consultation has been done or not.
Primary Purpose: Treatment
Official Title: Understanding Palliative Care and End of Life Needs in the ALS Population: The First Step to Improving Patient and Caregiver Quality of Life
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2022


Arm Intervention/treatment
No Intervention: Standard care
These ALS patients and their caregivers will receive standard care.
Experimental: Early palliative care
These patients will receive a palliative care consultation that would not be requested by their care team as standard of care.
Behavioral: Palliative Care consultation outside standard of care
The ALS patients and their caregivers will receive a consultation with a palliative care physician. This will take approximately one hour and occur in their location of choice (ie. often the patient's home). Subsequent palliative care consultations will occur at the discretion of the ALS patient and the palliative care physician.




Primary Outcome Measures :
  1. Change in average ALS Specific Quality of Life - Revised score in ALS patients post palliative care [ Time Frame: At baseline compared to 1 month and 3 months after palliative care consultation ]
    the change in the average score of ALS patients on the ALS Specific Quality of Life - Revised scale. On the scale the minimum score is 0 and the maximum score is 460. A higher score reflects a higher quality of life.

  2. Difference in average ALS Specific Quality of Life - Revised score between arms [ Time Frame: At baseline, 1 month and 3 months after palliative care consultation or study enrollment ]
    The difference between the average ALS Specific Quality of Life - Revised score between ALS patients who received the palliative care consultation and patients who did not. On the ALS Specific Quality of Life - Revised scale the minimum score is 0 and the maximum score is 460. A higher score reflects a higher quality of life.

  3. Difference in average Hospital Anxiety and Depression Scale score for ALS patients between arms [ Time Frame: At baseline, 1 month and 3 months after palliative care consultation or study enrollment ]
    The difference between the average Hospital Anxiety and Depression Scale score between ALS patients who received the palliative care consultation and patients who did not. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.

  4. Difference in average Hospital Anxiety and Depression Scale score for caregivers of ALS patients between arms [ Time Frame: At baseline, 1 month and 3 months after palliative care consultation or study enrollment ]
    The difference between the average Hospital Anxiety and Depression Scale score between caregivers of ALS patients who received the palliative care consultation and caregivers of patients who did not. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.

  5. Change in average Hospital Anxiety and Depression Scale score in patients with ALS [ Time Frame: At baseline compared to 1 month and 3 months post palliative care consultation ]
    the change in the average Hospital Anxiety and Depression Scale scores in ALS patients. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.

  6. Change in average Hospital Anxiety and Depression Scale score in caregivers of patients with ALS [ Time Frame: At baseline compared to 1 month and 3 months post palliative care consultation ]
    The change in the average Hospital Anxiety and Depression Scale scores for caregivers of ALS patients. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.


Secondary Outcome Measures :
  1. Patient satisfaction with palliative care consultation on the Satisfaction with Palliative Care Questionnaire [ Time Frame: at 24 months ]
    description of the average scores for questions on the Palliative care satisfaction.questionnaire. The minimum score is 9 and the maximum score is 45. A higher score indicates greater satisfaction with palliative care.

  2. care provided through palliative care consultation [ Time Frame: at 24 months ]
    description of type and frequency of issues covered as part of the palliative care consultation and the palliative care interventions provided

  3. reasons for decision to pursue palliative care consultation or not [ Time Frame: at 24 months ]
    description of the reasons patients list for pursuing or not pursuing palliative care consultation as well as the frequency of each reason

  4. Change in average ALS Specific Quality of Life - Revised score in ALS patients post palliative care [ Time Frame: At baseline compared to 6 month, 12 months, 15 months, 18 months, 21 months after palliative care consult ]
    the change in the average score of ALS patients on the ALS Specific Quality of Life - Revised scale. On the ALS Specific Quality of Life - Revised scale the minimum score is 0 and the maximum score is 460. A higher score reflects a higher quality of life.

  5. Change in average Hospital Anxiety and Depression Scale score in ALS patients post palliative care [ Time Frame: At baseline compared to 6 month, 12 months, 15 months, 18 months, 21 months after palliative care consult ]
    the change in the average score of ALS patients on the Hospital Anxiety and Depression Scale. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.

  6. Change in average Hospital Anxiety and Depression Scale score in caregivers of ALS patients post palliative care [ Time Frame: At baseline compared to 6 month, 12 months, 15 months, 18 months, 21 months after palliative care consult ]
    the change in the average score of caregivers of ALS patients on the Hospital Anxiety and Depression Scale. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.

  7. Difference in average ALS Specific Quality of Life - Revised score between arms [ Time Frame: at 6 months, 12 months, 15 months, 18 months, 21 months after palliative care consultation or study enrollment ]
    The difference between the average ALS Specific Quality of Life - Revised score between ALS patients who received the palliative care consultation and patients who did not.On the ALS Specific Quality of Life - Revised scale the minimum score is 0 and the maximum score is 460. A higher score reflects a higher quality of life.

  8. Difference in average Hospital Anxiety and Depression Scale score between arms in ALS patients [ Time Frame: at 6 months, 12 months, 15 months, 18 months, 21 months after palliative care consultation or study enrollment ]
    The difference between the average Hospital Anxiety and Depression Scale score between ALS patients who received the palliative care consultation and patients who did not.The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.

  9. Difference in average Hospital Anxiety and Depression Scale score between arms in caregivers of patients with ALS [ Time Frame: at 6 months, 12 months, 15 months, 18 months, 21 months after palliative care consultation or study enrollment ]
    The difference between the average Hospital Anxiety and Depression Scale score between caregivers of ALS patients who received the palliative care consultation and patients who did not. The minimum for depression or anxiety is 0. The maximum score for depression or anxiety is 21. The higher the score, the more pronounced the symptoms.


Other Outcome Measures:
  1. Proportion of patients who complete a palliative care consultation [ Time Frame: at 24 months ]
    The number of patients who choose to have a palliative care consultation as part of the study divided by the total number of patient participants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient with ALS at the Ottawa Hospital ALS clinic or caregiver of participating patient.

Exclusion Criteria:

Significant cognitive impairment Prior palliative care consultation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257760


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1S4X7
Sponsors and Collaborators
Ottawa Hospital Research Institute
ALS Society of Canada
Investigators
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Principal Investigator: Jocelyn C Zwicker, MD The Ottawa Hospital
Principal Investigator: Christine Watt, MD The Ottawa Hospital
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04257760    
Other Study ID Numbers: ALSPall1
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
amyotrophic lateral sclerosis
palliative care
caregivers
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases