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

NCT03555253 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-04-10

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis

Interventions

BEHAVIORAL

Resilience-Based Program for Support Partners of PwMS

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.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY
  • Healios Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-23
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555253 on ClinicalTrials.gov