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Resilience-Based Program for Support Partners of Persons With Multiple Sclerosis | Clinical Trials | Clareo Health

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Resilience-Based Program for Support Partners of Persons With Multiple Sclerosis

A Pilot Single-Center Study of a Manualized Resilience-Based Telehealth Program for Support Partners of Persons With Multiple Sclerosis

NCT03555253•Healios Inc.

View on ClinicalTrials.gov

Summary

This is a pilot feasibility study to examine the impact of providing a non-therapeutic resilience-based coaching telehealth program to the Support Partners (SP) of persons with MS (PwMS). Cognitive difficulties are a prominent feature in PwMS and prove to be a challenge for PwMS and the close family members that care for them. This study is a pilot telehealth program that aims to address these needs and improve the overall well-being of adults with MS and their Support Partners. A manualized program was developed utilizing the previous research study conducted literature, and the expertise and experience of the research study team. Funding was sought and obtained for 30 pairs to participate in the pilot. The 6-session program will address needs identified by this population and improve knowledge of cognition in PwMS. Study Objectives: Primary Objective: To conduct an evaluation of the feasibility of the resilience program by examining: 1. Recruitment (i.e. willingness to participate in program) 2. Participation rates and attrition 3. Participant satisfaction of the program. Secondary Objective (Support Partner): To assess the potential long-term benefits of the program to Support Partners of PwMS. Program benefits will be assessed using the following outcomes: 1. Sense of Competencies 2. Understanding of cognitive impairment in MS 3. Caregiver burden 4. Positive Emotions. Secondary Objective (PwMS): To assess the potential long-term benefits of the program to PwMS. Program benefits will be assessed using the following outcomes: 1. Relationship Satisfaction 2. Perceived Support.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•In order to be eligible to participate in this study as a Support Partner, an individual must meet all of the following criteria:
•1. Provide signed and dated informed consent form.
•2. Willing to comply with all study procedures and be available for the duration of the study.
•3. Male or female, aged 21 to 65 years.
•4. Able to speak, read, and understand English.
•5. Reside in the U.S.
•6. Live with PwMS who is willing to participate in the study and who meets all of the eligibility criteria.
•7. Has access to a telephone and computer or tablet with a stable internet connection as well as a web camera in a private setting.
•8. Provide identification that meets the New Jersey Telemedicine Act of 2017.
•9. Demonstrate basic ability to use a computer by completing the electronic ICF completion process, which requires use of a teleconferencing platform similar to what will be used during the intervention.
+12 more criteria

Exclusion Criteria

•A Support Partner who meets any of the following criteria will be excluded from participation in this study:
•1. Professional healthcare worker (e.g., physician, psychologist, social worker, case manager, nurse, home healthcare aide).
•2. Dementia, including Alzheimer's and Lewy Bodies Dementia, as screened by CORE Therapy Assessment Form v.2.
•3. Reports that PwMS partner is diagnosed with dementia, including Alzheimer's and Lewy Bodies Dementia.
•4. Self-report of any change in medication treating bipolar disorder and any psychiatric condition, including a change in dosage, in the previous 6 months and as screened by CORE Therapy Assessment Form v.2.
•5. Current suicidal intent as screened by CORE-OM and CORE Therapy Assessment Form v.2.
•6. Currently participating in couple or family therapy.
•7. An intellectual or developmental disability as screened by CORE Therapy Assessment Form v.2.
•8. Evidence of significant brain injury or medical condition leading to cognitive impairment (e.g. accident, tumor) as screened by CORE Therapy Assessment Form v.2.
•9. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
+9 more criteria

Locations (1)

Healios, Inc.

Flemington, New Jersey, United States

Key Dates

Start Date

May 23, 2018

Primary Completion Date

March 31, 2019

Completion Date

March 31, 2019

Last Updated

April 10, 2019

Enrollment

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

Resilience-Based Program for Support Partners of PwMS

BEHAVIORAL

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Resilience-Based Program for Support Partners of Persons With Multiple Sclerosis

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

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