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

NCT03555253 | Completed

• 1 other identifier: Protocol R-PILO-MSOO-010-0002
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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. 1.Recruitment (i.e. willingness to participate in program)
2. 2.Participation rates and attrition
3. 3.Participant satisfaction of the program.
4. 4.Sense of Competencies
5. 5.Understanding of cognitive impairment in MS
6. 6.Caregiver burden
7. 7.Positive Emotions.
8. 8.Relationship Satisfaction
9. 9.Perceived Support.

Conditions

Multiple Sclerosis

Keywords

Resilience; Telehealth; Well-being; Support; Caregiving

Outcome Measures

Primary Outcomes (3)

• Feasibility: Recruitment (i.e. willingness to participate in program)

  Recruitment will end when 30 fully evaluable Support Partner - PwMS pairs have completed the study. It is expected that approximately 45 pairs will be enrolled in order to produce the 30 fully evaluable pairs.

  Up to 1 year

• Feasibility: Participation rates and attrition

  Participation rates will be measured in terms of individual sessions completed. Attrition rates will be measured. Attrition or drop-out will be addressed as follows: those who drop out prior to the fourth session will be asked to complete a satisfaction questionnaire while those who drop out after the fourth session will be asked to complete post-measures and a satisfaction questionnaire.

  Up to 1 year

• Feasibility: Participant satisfaction of the program.

  The Intervention Evaluation Questionnaire was created by the research lead as a self-report measure of the participant's evaluation of the intervention and the individual sessions. Participants' evaluation data will be presented as totals from one five-point Likert scale, three yes/no questions and four open questions. The scale question measures satisfaction with the program on a range from 0 (not at all satisfied) to 4 (very satisfied). In addition to this evaluation of the intervention, four questions will be asked at the end of each session to the participants of that session. This includes two five-point Likert scale questions and two open ended questions. The first scale question measures satisfaction with the session on a range from 1 (not at all satisfied) to 5 (very satisfied). The second scale question measures the perceived helpfulness of the session on a range from 1 (not at all satisfied) to 5 (very satisfied).

  Up to 1 year

Secondary Outcomes (11)

• Change from Baseline: Sense of Competence Questionnaire (Support Partner)

  Up to 8 months from enrollment

• Change from Baseline: Connor-Davidson Resilience Scale (Support Partner)

  Up to 8 months from enrollment

• Change from Baseline: Zarit Burden Interview (Support Partner)

  Up to 8 months from enrollment

• Change from Baseline: Perceived Stress (Support Partner)

  Up to 8 months from enrollment

• Change from Baseline: Knowledge Questionnaire (Support Partner)

  Up to 8 months from enrollment

Study Arms (1)

PwMS and their Support Partner

EXPERIMENTAL

Support Partners will participate in six resilience coaching Program Sessions conducted weekly by a study resilience coach. PwMS will participate in the initial and final coaching Program Sessions with their Support Partners.

Behavioral: Resilience-Based Program for Support Partners of PwMS

Interventions

Resilience-Based Program for Support Partners of PwMS BEHAVIORAL

Support Partners will participate in six resilience coaching Program Sessions conducted weekly by a study resilience coach. PwMS will participate in the initial and final coaching Program Sessions with their Support Partners. The MyHealios Resilience Program for PwMS and their Support Partners has been designed to be interactive and include skills-based activities led by the Resilience coach. This includes skills of communication, problem solving, and learning about resilience and cognition in MS.

PwMS and their Support Partner

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study as a Support Partner, an individual must meet all of the following criteria:
• Provide signed and dated informed consent form.
• Willing to comply with all study procedures and be available for the duration of the study.
• Male or female, aged 21 to 65 years.
• Able to speak, read, and understand English.
• Reside in the U.S.
• Live with PwMS who is willing to participate in the study and who meets all of the eligibility criteria.
• Has access to a telephone and computer or tablet with a stable internet connection as well as a web camera in a private setting.
• Provide identification that meets the New Jersey Telemedicine Act of 2017.
• 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.

You may not qualify if:

• A Support Partner who meets any of the following criteria will be excluded from participation in this study:
• Professional healthcare worker (e.g., physician, psychologist, social worker, case manager, nurse, home healthcare aide).
• Dementia, including Alzheimer's and Lewy Bodies Dementia, as screened by CORE Therapy Assessment Form v.2.
• Reports that PwMS partner is diagnosed with dementia, including Alzheimer's and Lewy Bodies Dementia.
• 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.
• Current suicidal intent as screened by CORE-OM and CORE Therapy Assessment Form v.2.
• Currently participating in couple or family therapy.
• An intellectual or developmental disability as screened by CORE Therapy Assessment Form v.2.
• 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.
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
• In order to be eligible to participate in this study as a Person with MS, an individual must meet all of the following criteria:
• Provide signed and dated informed consent form.
• Willing to comply with all study procedures and be available for the duration of the study.
• Male or female, aged 21 to 65 years.
• Self-report of Multiple Sclerosis including the date of the diagnosis (month and year) and the name of the diagnosing physician.

Sponsors & Collaborators

• Healios Inc.: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Healios, Inc.

Flemington, New Jersey, 08822, United States

Location

Related Publications (1)

• 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.

  PMID: 32913660 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 13, 2018
• Study Start: May 23, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

US (1)