A Pilot Single-Center Study of a Manualized Resilience-Based Telehealth Program for Support Partners of Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Healios Inc.
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Feasibility: Recruitment (i.e. willingness to participate in program)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •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
- •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
排除标准
- •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.
- •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.
- •Current suicidal intent as screened by CORE-OM and CORE Therapy Assessment Form v.
- •Currently participating in couple or family therapy.
- •An intellectual or developmental disability as screened by CORE Therapy Assessment Form v.
- •Evidence of significant brain injury or medical condition leading to cognitive impairment (e.g. accident, tumor) as screened by CORE Therapy Assessment Form v.
- •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:
- •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.
- •Able to speak, read, and understand English.
- •Reside in the U.S.
- •Cognitive difficulty as screened by the PDQ Cognitive Function (score greater than 20).
- •Live with Support Partner who meets all study 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
- •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:
- •Dementia, including Alzheimer's and Lewy Bodies Dementia, as screened by CORE Therapy Assessment Form v.
- •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.
- •Current suicidal intent as screened by CORE-OM and CORE Therapy Assessment Form v.
- •Currently participating in couple or family therapy.
- •Diagnosis of intellectual or developmental disability as screened by CORE Therapy Assessment Form v.
- •Significant brain injury or medical condition leading to cognitive impairment (e.g. accident, tumor) as screened by CORE Therapy Assessment Form v.
- •Self-report of any change in medication treating MS, including a change dosage, in the previous 3 months.
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
研究组 & 干预措施
PwMS and their Support Partner
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.
干预措施: Resilience-Based Program for Support Partners of PwMS (Behavioral)
结局指标
主要结局
Feasibility: Recruitment (i.e. willingness to participate in program)
时间窗: 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
时间窗: 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.
时间窗: 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).
次要结局
- 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)
研究者
Elizabeth Halstead
Principal Investigator
Healios Inc.