A Pilot Single-Center Study of a Manualized Resilience-Based Telehealth Program for Support Partners of Persons With Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Healios Inc.
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Feasibility: Recruitment (i.e. willingness to participate in program)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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:
- Recruitment (i.e. willingness to participate in program)
- Participation rates and attrition
- 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:
- Sense of Competencies
- Understanding of cognitive impairment in MS
- Caregiver burden
- 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:
- Relationship Satisfaction
- Perceived Support.
Investigators
Elizabeth Halstead
Principal Investigator
Healios Inc.
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility: Recruitment (i.e. willingness to participate in program)
Time Frame: Up to 1 year
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.
Feasibility: Participation rates and attrition
Time Frame: Up to 1 year
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.
Feasibility: Participant satisfaction of the program.
Time Frame: Up to 1 year
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).
Secondary Outcomes
- 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: Knowledge Questionnaire (Support Partner)(Up to 8 months from enrollment)
- Change from Baseline: Modified Social Support Survey (Person with Multiple Sclerosis)(Up to 8 months from enrollment)
- Change from Baseline: Burns Relationship Satisfaction Scale (Person with Multiple Sclerosis)(Up to 8 months from enrollment)
- Change from Baseline: Sense of Competence Questionnaire (Support Partner)(Up to 8 months from enrollment)
- Change from Baseline: Perceived Stress (Support Partner)(Up to 8 months from enrollment)
- Change from Baseline: Positive and Negative Affect Schedule (Support Partner)(Up to 8 months from enrollment)
- Change from Baseline: Burns Relationship Satisfaction Scale (Support Partner)(Up to 8 months from enrollment)
- Change from Baseline: Relationship Assessment Scale (Support Partner)(Up to 8 months from enrollment)
- Change from Baseline: Relationship Assessment Scale (Person with Multiple Sclerosis)(Up to 8 months from enrollment)