HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS) - Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change in quality of life in MS participants as measured by comparing PROMIS-10 Global Health scores at baseline and at 3 months post-intervention.
研究概览
简要总结
The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-MS to improve the quality of life and cognitive function in Service Members, Veterans and civilians who have multiple sclerosis with cognitive and memory problems (MS participants). This study will also assess the ability of the HOBSCOTCH-MS program to improve quality of life in caregivers of patients with multiple sclerosis and to reduce caregiver burden. Enrolling with a Caregiver is optional for MS participants.
Investigators will compare two groups of MS participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOTCH-MS immediately (Group 1) and another group that will receive HOBSCOTCH-MS (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total.
HOBSCOTCH-MS involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a "pre" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. MS participants are asked to do short homework assignments and both MS and Caregiver participants are asked to keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study).
After completing the intervention, MS Participants and their Caregivers may also participate in an optional one-time Key Informant Interview for qualitative analysis in an effort to further adapt and improve the HOBSCOTCH-MS in the future.
详细描述
The investigators' hypothesis is that the telehealth delivered evidence-based intervention HOBSCOTCH-MS can be delivered by telehealth to improve QOL and neurocognitive function in PwMS. The innovative integration of care partner participation in the proposed coproduced adapted intervention, HOBSCOTCH-MS, will reduce care partner burden and increase care partner knowledge of their loved one's disease and the cognitive challenges they face, leading to an improvement in care partner QOL.
SPECIFIC AIMS: The investigators will test their hypothesis by pursuing the following specific aims:
Aim 1. Evaluate the efficacy of HOBSCOTCH-MS in persons with MS. The investigators' working hypothesis is that treatment will be associated with gains in QOL and subjective cognition in people with multiple sclerosis. The investigators also expect to see improvements in problem-solving ability, objective cognition, knowledge, self-efficacy, and mood. We will examine predictors of response to treatment, including baseline cognition, mood, fatigue, and demographic and disease variables, and mediators including problem-solving abilities and self-efficacy.
Aim 2. Evaluate the efficacy of HOBSCOTCH-MS in care partners (caregivers). The investigators' working hypothesis is that care partners (caregivers) will have improvement in health-related QOL, care partner burden, knowledge, self-efficacy, and mood as a result of their family member with MS participating in the intervention, and by their own participation in education and mindfulness exercises.
Aim 3: Collect and synthesize key informant interview data from a subset of participating people with multiple sclerosis (MS participants) and their Care Partners (Caregiver participants) to inform a future larger scale trial. The investigators' working hypothesis is this qualitative data will assist with refinements to materials and/or program delivery that would recognize and validate key input from people with multiple sclerosis and their care partners (caregivers), allowing the investigators to plan for future large scale research trials and program dissemination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria - MS Participant
- •Age 20 - 75 years
- •Diagnosis of relapsing or progressive MS
- •Education of at least Grade 12 or GED
- •Fluent in English
- •Subjective cognitive and memory challenges
- •Internet access
- •Telephone access
- •Inclusion Criteria - Caregiver Participant
- •20 years +
- •Fluent in English
- •Caregiver to a MS Participant
- •Participant MS has given permission to Caregiver to enroll with them
- •Internet access
- •Telephone access
排除标准
- •Exclusion Criteria MS Participant
- •Current diagnosed psychiatric disorders (e.g., schizophrenia, bipolar disorder or substance use disorder).
- •Other neurological disorder such as epilepsy, brain tumor, severe brain injury or mild to moderate brain injury with a history of 30 or more minutes' loss of consciousness, or other disorder that would confound the focus on MS
- •Diagnosed developmental attention, learning, or intellectual disorder; sensory, motor, or physical disability that would prevent engagement with the intervention or render the person unable complete study outcome measures
- •Exacerbation of MS symptoms (relapse) or ongoing steroid treatment within three months of study enrollment
- •Significant visual impairment precluding reading or writing
- •Lack of access to the technical resources (e.g., internet access, telephone) required for participation
- •Exclusion Criteria - Caregiver Participant
- •Significant visual impairment precluding reading or writing
- •No reliable telephone or internet access
研究组 & 干预措施
MS Participant Group 1
MS Participant Group 1 will receive the HOBSCOTCH-MS intervention consisting of 1:1 sessions delivered once per week including:
- 1 pre-HOBSCOTCH
- Session (on webcam)
- 1 educational session (on webcam)
- 6 telephone sessions
- 1 wrap-up session (webcam or telephone)
干预措施: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS) (Behavioral)
MS Participant Group 2
MS Participant Group 2 will be on a 3-month wait list after which they will receive HOBSCOTCH-MS consisting of 1:1 sessions delivered once per week including:
- 1 pre-HOBSCOTCH
- Session (on webcam)
- 1 educational session (on webcam)
- 6 telephone sessions
- 1 wrap-up session (webcam or telephone)
干预措施: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS) (Behavioral)
MS Caregiver Group 1
Caregiver Group 1 will receive an adapted version of HOBSCOTCH-MS by attending the introductory session and session 1 of the HOBSCOTCH-MS (virtual) program with their MS participant as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the MS patient to focus on program wrap-up and maintenance planning.
干预措施: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS) (Behavioral)
MS Caregiver Group 2
Caregiver Group 2 will be on a 3 month wait list with their MS participant after which time they will receive an adapted version of HOBSCOTCH-MS by attending the introductory session and session 1 of the HOBSCOTCH-MS (virtual) program with their MS patient as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the MS patient to focus on program wrap-up and maintenance planning.
干预措施: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS) (Behavioral)
结局指标
主要结局
Change in quality of life in MS participants as measured by comparing PROMIS-10 Global Health scores at baseline and at 3 months post-intervention.
时间窗: Baseline and 3 months post-intervention
PROMIS Global-10 Global Health is a validated 10-question survey and part of the Patient-Reported Outcomes Measurement Information System (PROMIS) used to assess health care-related quality of life. Measures include overall health, pain, fatigue, social health, mental health, and physical health. 9 of the items are scored on a Likert Scale of 1 - 5 with 5 representing the best health care-related quality of life; higher scores are associated with better quality of life. One item related to pain is measured on a scale of 1 - 10 with 10 being the worst possible pain.
Change in subjective cognitive function in MS participants as measured by comparing scores on the Cognitive Function Sub-Scale (Item Bank 2.0) of the Neuro-QOL at baseline and at 3 months post-intervention.
时间窗: Baseline and 3 months post-intervention
The Cognitive Function sub-scale of the Neuro-QOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Change in Caregiver participants caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention.
时间窗: Baseline and 3 months post-intervention
The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5 point Likert scale is used with a higher score indicating a greater level of perceived burden.
次要结局
- HOBSCOTCH-MS fidelity as measured by MS participant's compliance with weekly homework assignments.(Week 1 through Week 8 of HOBSCOTCH-MS intervention.)
- Changes in MS and Caregiver participants' knowledge of relationship between the condition of MS and cognition and memory as measured by comparing scores on the HOBSCOTCH-MS Knowledge Questionnaire at baseline and at 6 months (end of study).(Baseline and at 6 months (end of study))
- Change in MS participants quality of life as measured by comparing FAMS-Functional Assessment of Multiple Sclerosis v4.0 scores at base line and at 3 months post-HOBSCOTCH-MS intervention.(Baseline and 3 months post-intervention)
- Change in MS participants objective cognitive processing speed as measured by comparing Symbol-Digit Modalities Test scores (orally) at base line and at 3 months post-HOBSCOTCH-MS intervention.(Baseline and 3 months post-intervention)
- Change in MS participants verbal learning and memory as measured by comparing California Verbal Learning Test-III scores at baseline and 3 months post-HOBSCOTCH-MS intervention(Baseline and 3 months post-intervention)
- Change in MS participants visuospatial learning and memory as measured by comparting Brief Visuospatial Memory Test-Revised (BVMT-R) scores at baseline and 3 months post-HOBSCOTCH-MS intervention(Baseline and 3 months post-intervention)
- Changes in MS participants executive function as measured by comparing scores on the self-reported Behavior Inventory of Executive Function-Adult Version (BRIEF-A) at baseline and 3-months post intervention.(Baseline and 3 months post-intervention)
- Changes in MS participants self-efficacy as measured by comparing scores on the PROMIS (Patient-Reported Outcomes Measurement Information System) Item Bank v1.0 General Self-Efficacy assessment at baseline and 3-months post-intervention.(Baseline and 3 months post-intervention)
- Changes in MS participants and Caregiver participants mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.(Baseline and 3 months post-intervention)
- Changes in MS participants and Caregiver participants anxiety as measured by comparing score on the Generalized Anxiety Disorder-7 (GAD-7) at baseline and at 3-months post-intervention.(Baseline and 3 months post-intervention)
- Changes in MS participants' symptom frequency as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention)
- Changes in MS participants' medication adherence as measured by a daily self-reported diary of compared at baseline and at 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention)
- Changes in MS participants' use of memory strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention)
- Changes in Caregiver participants use of quick relaxation strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention)
- Changes in MS participants and MS Caregiver participants self-reports of wellbeing as measured by comparing daily reports of well-being in a diary at baseline and at 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention)
- Engagement and Satisfaction for MS participants as measured by analyzing study attrition and a Participant Satisfaction Survey at the end of the study.(At 6 months (end of study participation))
- Engagement and Satisfaction for MS Participants as measured by CollaboRATE post-study completion.(At 6 months (end of study participation).)
- Changes in MS Caregiver participants self-reported health status as measured by comparing scores on the Short-Form Health Survey 36 (SF-36) at baseline and 3 months-post HOBSCOTCH MS intervention.(Baseline and 3 months post-intervention)
- Feasibility of HOBSCOTCH-MS program for Caregivers as measured by study attrition and a Participant Satisfaction Survey.(At 6 months (end of study participation))
- Sustainability of improvement on primary outcome measure of quality of life for Group 1 MS Participants by comparing scores on the PROMIS 10-Global Health at 3 months and 6 months post-intervention.(3 months and 6 months post intervention)
- Sustainability of improvement on primary outcome measure of quality of life for Group 1 MS Participants by comparing scores on the Neuro-QOL at 3 months and 6 months post-intervention.(3 months and 6 months post intervention)
- Sustainability of improvement on primary outcome measures for Group 1 Caregiver Participants by comparing scores on the Zarit Caregiver Burden at 3 months and 6 months post-intervention.(3 months and 6 months post intervention)
研究者
Elaine T. Kiriakopoulos
Elaine T. Kiriakopoulos, MD, MPH, MSc Assistant Professor of Neurology, Geisel School of Medicine at Dartmouth Director, HOBSCOTCH Institute for Cognitive Health & Well-Being Dartmouth Hitchcock Epilepsy Center
Dartmouth-Hitchcock Medical Center