Clinical trial NCT03555253: Resilience-Based Program for Support Partners of Persons With Multiple Sclerosis
Official title: A Pilot Single-Center Study of a Manualized Resilience-Based Telehealth Program for Support Partners of Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Resilience
Telehealth
Well-being
Support
Caregiving
Lead sponsor: Healios Inc.
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2018-06-13
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: Support Partner 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.

Support Partner 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.

PwMS Inclusion Criteria

In order to be eligible to participate in this study as a Person with MS, 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. Self-report of Multiple Sclerosis including the date of the diagnosis (month and year) and the name of the diagnosing physician.
5. Able to speak, read, and understand English.
6. Reside in the U.S.
7. Cognitive difficulty as screened by the PDQ Cognitive Function (score greater than 20).
8. Live with Support Partner who meets all study eligibility criteria.
9. Has access to a telephone and computer or tablet with a stable internet connection as well as a web camera in a private setting.
10. Provide identification that meets the New Jersey Telemedicine Act of 2017.
11. 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.

PwMS Exclusion Criteria

A PwMS who meets any of the following criteria will be excluded from participation in this study:

1. Dementia, including Alzheimer's and Lewy Bodies Dementia, as screened by CORE Therapy Assessment Form v.2.
2. 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.
3. Current suicidal intent as screened by CORE-OM and CORE Therapy Assessment Form v.2.
4. Currently participating in couple or family therapy.
5. Diagnosis of intellectual or developmental disability as screened by CORE Therapy Assessment Form v.2.
6. Significant brain injury or medical condition leading to cognitive impairment (e.g. accident, tumor) as screened by CORE Therapy Assessment Form v.2.
7. Self-report of any change in medication treating MS, including a change dosage, in the previous 3 months.
8. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Primary outcomes:
measure: Feasibility: Recruitment (i.e. willingness to participate in program)
timeFrame: Up to 1 year
measure: Feasibility: Participation rates and attrition
timeFrame: Up to 1 year
measure: Feasibility: Participant satisfaction of the program.
timeFrame: Up to 1 year
Secondary outcomes:
measure: Change from Baseline: Sense of Competence Questionnaire (Support Partner)
timeFrame: Up to 8 months from enrollment
measure: Change from Baseline: Connor-Davidson Resilience Scale (Support Partner)
timeFrame: Up to 8 months from enrollment
measure: Change from Baseline: Zarit Burden Interview (Support Partner)
timeFrame: Up to 8 months from enrollment
measure: Change from Baseline: Perceived Stress (Support Partner)
timeFrame: Up to 8 months from enrollment
measure: Change from Baseline: Knowledge Questionnaire (Support Partner)
timeFrame: Up to 8 months from enrollment
measure: Change from Baseline: Positive and Negative Affect Schedule (Support Partner)
timeFrame: Up to 8 months from enrollment
measure: Change from Baseline: Burns Relationship Satisfaction Scale (Support Partner)
timeFrame: Up to 8 months from enrollment
measure: Change from Baseline: Relationship Assessment Scale (Support Partner)
timeFrame: Up to 8 months from enrollment
measure: Change from Baseline: Modified Social Support Survey (Person with Multiple Sclerosis)
timeFrame: Up to 8 months from enrollment
measure: Change from Baseline: Burns Relationship Satisfaction Scale (Person with Multiple Sclerosis)
timeFrame: Up to 8 months from enrollment
measure: Change from Baseline: Relationship Assessment Scale (Person with Multiple Sclerosis)
timeFrame: Up to 8 months from enrollment
Other outcomes:
Locations:
city: Flemington
country: United States
facility: Healios, Inc.
state: New Jersey
Study officials:
References:
citation: Halstead EJ, Leavitt VM, Fiore D, Mueser KT. A feasibility study of a manualized resilience-based telehealth program for persons with multiple sclerosis and their support partners. Mult Scler J Exp Transl Clin. 2020 Aug 21;6(3):2055217320941250. doi: 10.1177/2055217320941250. eCollection 2020 Jul-Sep.