Resilience-Based Program for Support Partners of Persons With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: Resilience-Based Program for Support Partners of PwMS
- Registration Number
- NCT03555253
- Lead Sponsor
- Healios Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PwMS and their Support Partner 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.
- Primary Outcome Measures
Name Time Method Feasibility: Recruitment (i.e. willingness to participate in program) 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 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. 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 Outcome Measures
Name Time Method Change from Baseline: Connor-Davidson Resilience Scale (Support Partner) Up to 8 months from enrollment The 10-item version of the Connor-Davidson Resilience Scale will be used to measure the Support Partner's sense of their resilience when faced with stressful situations and negative emotions. The measure includes a total of ten items. Each item on the scale is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Not True at All) to 4 (True Nearly All the Time).
Change from Baseline: Zarit Burden Interview (Support Partner) Up to 8 months from enrollment The Zarit Burden Interview will be used to measure the Support Partner's feelings of burden related to caregiving. There are twenty-two items total. Each item is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).
Change from Baseline: Knowledge Questionnaire (Support Partner) Up to 8 months from enrollment The knowledge questionnaire was created by the research lead as a self-report measure of participant retention of the program's topics. The questionnaire has thirteen questions, nine which are multiple-choice questions whose response options are based on the session contents. There are also four scale questions. The first scale question measures the participant's self-reported resilience from 1 (not resilient at all) to 10 (very resilient). The second scale question measures the participant's comfort with their knowledge about cognition in multiple sclerosis from 1 (not comfortable at all) to 10 (very comfortable). The third scale question measures the participant's effectiveness at communicating with their partner from 1 (not effective at all) to 10 (very effective). The fourth scale question measures the participant's effectiveness when using problem-solving skills in dealing with day-to-day difficulties from 1 (not effective at all) to 10 (very effective).
Change from Baseline: Modified Social Support Survey (Person with Multiple Sclerosis) Up to 8 months from enrollment The Modified Social Support Survey (MSSS) will be used to measure the MS participant's perceived social support. The MSSS consists of 18 items. Each item presents a statement that the MS participant is asked to endorse on a 5-point scale. Response options range from 1 (none of the time) to 5 (all of the time). The MSSS has four subscales that measure different dimensions of social support, including tangible support (4 items), emotional support (8 items), affective support (3 items) and positive support (3 items).
Change from Baseline: Burns Relationship Satisfaction Scale (Person with Multiple Sclerosis) Up to 8 months from enrollment The Burns Relationship Satisfaction Scale will be used to assess the MS participant's self-reported level of satisfaction in various areas of the relationship with the support partner for spousal dyads. The BRSS has seven items. Each item describes a relationship area: communication and openness, conflict resolution, degree of caring and affection, intimacy and closeness, satisfaction with roles in relationship, and overall relationship satisfaction. The MS participant is asked to rate their degree of satisfaction in each of these areas. Response options range from 0 (very dissatisfied) to 6 (very satisfied).
Change from Baseline: Sense of Competence Questionnaire (Support Partner) Up to 8 months from enrollment The Sense of Competence Questionnaire will be used to measure the support partner's sense of competence in caring for a person with MS. The measure has twenty-seven items. Each item is a statement which the support partner is asked to endorse using a 5-point scale. Response options range from 1 (Yes, completely agrees) to 5 (no, completely disagrees). The three subscales are: satisfaction with care recipient (7 items), satisfaction with one's performance as a support partner (12 items), and consequences of involvement in care for the personal life of the support partner (8 items).
Change from Baseline: Perceived Stress (Support Partner) Up to 8 months from enrollment The Perceived Stress Survey (PSS) will be used to measure the support partner's perceptions about the nature of events and their relationship to the support partner's values and perceived coping resources. The PSS has 14 items total. Each item is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Very often).
Change from Baseline: Positive and Negative Affect Schedule (Support Partner) Up to 8 months from enrollment The Positive and Negative Affect Schedule will be used to measure the support partner's self-reported experience of positive and negative affect in the past week. The full PANAS has 20 items total. Each item describes an emotion, the recent experience of which (currently at the time of reporting or within the past week) the support partner is asked to endorse using a 5-point scale. Response options range from 1 (feeling the emotion slightly or not at all) or 5 (feeling the emotion often). Ten items describe positive emotion and ten items describe negative emotion.
Change from Baseline: Burns Relationship Satisfaction Scale (Support Partner) Up to 8 months from enrollment The Burns Relationship Satisfaction Scale (BRSS) will be used to assess the support partner's self-reported level of satisfaction in various areas of the relationship with the care recipient for spousal dyads. The BRSS has seven items. Each item describes a relationship area: communication and openness, conflict resolution, degree of caring and affection, intimacy and closeness, satisfaction with roles in relationship, and overall relationship satisfaction. The support partner is asked to rate their degree of satisfaction in each of these areas. Response options range from 0 (very dissatisfied) to 6 (very satisfied).
Change from Baseline: Relationship Assessment Scale (Support Partner) Up to 8 months from enrollment The Relationship Assessment Scale (RAS) will be used to assess the support partner's self-reported level of satisfaction with their relationship with the care recipient. The RAS will only be used in the case of non-spousal dyads. The RAS has seven items. Each item is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 1 (low) to 5 (high). Items 4 and 7 are reverse-scored. Scoring is kept continuous; the higher the score, the more satisfied the respondent is with his/her relationship.
Change from Baseline: Relationship Assessment Scale (Person with Multiple Sclerosis) Up to 8 months from enrollment The Relationship Assessment Scale will be used to assess the MS participant's self-reported level of satisfaction with their relationship with the support partner. The RAS will only be used in the case of non-spousal dyads. The RAS has seven items. Each item is a statement which the MS participant is asked to endorse using a 5-point scale. Response options range from 1 (low) to 5 (high). Items 4 and 7 are reverse-scored. Scoring is kept continuous; the higher the score, the more satisfied the respondent is with his/her relationship.
Trial Locations
- Locations (1)
Healios, Inc.
🇺🇸Flemington, New Jersey, United States