Идёт набор NCT06951919

HOBSCOTCH-MS-Efficacy Trial

Без фазы С лечением Multiple Sclerosis Cognitive Dysfunction Memory Disorders Memory Impairment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS).
Кому может быть актуально: Состояния в реестре: Multiple Sclerosis, Cognitive Dysfunction, Memory Disorders, Memory Impairment. Базовые параметры: 20 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS) - Efficacy Trial

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-MS is an adaptation of the HOBSCOTCH program specifically for people who have multiple sclerosis. It incorporates education about these conditions

Первичные конечные точки

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. [Срок оценки: Baseline and 3 months post-intervention]
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. [Срок оценки: Baseline and 3 months post-intervention]
Change in Caregiver participants caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention. [Срок оценки: Baseline and 3 months post-intervention]

Вторичные конечные точки (12)

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). [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Recorded daily and compared between baseline and 3 months post-intervention]

Критерии участия

Критерии включения

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

Критерии исключения

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