Budowanie odporności w diadach pacjentów z ANI przyjętych na Neuro-OIOM i ich nieformalnych opiekunów
Wspólna rekonwalescencja: budowanie odporności w parach pacjentów z ostrym uszkodzeniem mózgu przyjętych na oddział intensywnej terapii neurologicznej i ich nieformalnych opiekunów
The purpose of the present investigation is to test the efficacy of a brief (6 sessions) dyadic (patient and caregiver together) intervention to prevent chronic emotional distress in at risk dyads admitted to a Neuroscience Intensive Care Unit with an acute brain injury. Through this study, we seek to solve the unmet need of preventing chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads through a feasible, acceptable and credible program, and ideally improve the recovery trajectory and dyads' overall quality of life.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
The goals of this study are to: 1) demonstrate the efficacy of Recovering Together for improving self-reported emotional distress (primary outcome), and post traumatic stress, mindfulness, coping, social support and other relevant outcomes (secondary outcomes); and 2) assess mechanisms (mediators and moderators) of improvement after intervention. We will enroll and randomly assign 194 at risk dyads (97 per study group) to receive either the active intervention or educational control. The trial is single blinded (assessors, patients and staff). The trial will take place at the Massachusetts General Hospital NICU using our established methodology successfully implemented during the R21 pilot study. Study clinicians will deliver 6, 30 minute sessions of active intervention or educational control (2 at bedside and 4 via live video after discharge) to each patient-caregiver dyad. All participants will complete measures at baseline, after completion of program (6 weeks) and 3 months later. They will also complete measures of emotional distress weekly, as well as measures assessing home practice.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02114
- Massachusetts General Hospital (MGH)
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age 18 or older
- English fluency and literacy
- Patient with an informal caregiver available and willing to participate
- Hospitalized with any ANI within 6 weeks (patient) OR informal caregiver of a patient currently admitted with any ANI
- Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores > 7)
Exclusion Criteria:
- Permanent cognitive impairment (including severe hearing impairment) or aphasia that makes participation impossible
- Short form of Mini-Mental State Exam (SMMSE) score <4 (If SMMSE <4, nursing team decides whether or not the patient can meaningfully participate)
- Glasgow Coma Scale (GCS) score <10
- Terminal diagnosis
- Lack of access to internet and/or a device with a camera
- Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Experimental Patient-Caregiver Dyads
There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily skills. |
In the skills-based intervention group, sessions focus on developing skills to cope and manage ANI related stressors. The intervention will be tailored consistent with AHA recommendations for ANI skills-based interventions and will include 2 general and 4 specific modules. It is anticipated that the intervention will have 6 sessions with 2 general sessions delivered, in person if possible, within the NICU, or through live video using Zoom if patients leave the hospital before sessions occur, and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom.
Inne nazwy:
Those in the educational program will receive general health information that mimics the skills-based intervention, but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. There will also be 6 sessions, 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits following discharge. The educational program group will not have the opportunity to specify which modules they would like to take; the modules will be predetermined. All participants will receive medical care as determined by their medical team.
Inne nazwy:
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Aktywny komparator: Control Patient-Caregiver Dyads
There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily educational. |
In the skills-based intervention group, sessions focus on developing skills to cope and manage ANI related stressors. The intervention will be tailored consistent with AHA recommendations for ANI skills-based interventions and will include 2 general and 4 specific modules. It is anticipated that the intervention will have 6 sessions with 2 general sessions delivered, in person if possible, within the NICU, or through live video using Zoom if patients leave the hospital before sessions occur, and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom.
Inne nazwy:
Those in the educational program will receive general health information that mimics the skills-based intervention, but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. There will also be 6 sessions, 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits following discharge. The educational program group will not have the opportunity to specify which modules they would like to take; the modules will be predetermined. All participants will receive medical care as determined by their medical team.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Emotional Distress
Ramy czasowe: 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months
|
Hospital Depression and Anxiety Scale total score (HADS); 0-21 for each subscale (anxiety and depression), higher scores indicate greater anxiety or depression |
0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Post-Traumatic Stress
Ramy czasowe: 0 weeks, 6 weeks, 3 months
|
Post-Traumatic Stress Disorder Checklist - Specific Event (PCL-S); 17-85, higher scores indicate greater post-traumatic stress |
0 weeks, 6 weeks, 3 months
|
|
Change in Resiliency Factors (Mindfulness - curiosity and de-centering)
Ramy czasowe: 0 weeks, 6 weeks, 3 months
|
Toronto Mindfulness Scale-Trait (TMS-Trait); 0-52, higher scores indicate greater perceived mindfulness (specifically curiosity and de-centering) |
0 weeks, 6 weeks, 3 months
|
|
Change in Resiliency Factors (Mindfulness)
Ramy czasowe: 0 weeks, 6 weeks, 3 months
|
Cognitive and Affective Mindfulness Scale (CAMS); 12-48, higher scores indicate greater perceived mindfulness |
0 weeks, 6 weeks, 3 months
|
|
Change in Resiliency Factors (Individual Coping)
Ramy czasowe: 0 weeks, 6 weeks, 3 months
|
Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope |
0 weeks, 6 weeks, 3 months
|
|
Change in Resiliency Factors (Dyadic Coping)
Ramy czasowe: 0 weeks, 6 weeks, 3 months
|
Dyadic Coping Inventory (DCI); 35-175; higher scores indicate greater perceived coping in the context of a relationship |
0 weeks, 6 weeks, 3 months
|
|
Change in Interpersonal Factors (perceived social support)
Ramy czasowe: 0 weeks, 6 weeks, 3 months
|
Interpersonal Support Evaluation List-12 (ISEL-12); 0-48, higher scores indicate greater perceived social support |
0 weeks, 6 weeks, 3 months
|
|
Change in Interpersonal Factors (avoidant or anxious communication)
Ramy czasowe: 0 weeks, 6 weeks, 3 months
|
Experiences in Close Relationships Scale short form (ECR-S); 7-42, higher scores indicate greater avoidant or anxious communication |
0 weeks, 6 weeks, 3 months
|
|
Change in Interpersonal Factors (dyadic strain and positive interpersonal interactions)
Ramy czasowe: 0 weeks, 6 weeks, 3 months
|
Dyadic Relationship Scale (DRS); Patient version: 10-40, caregiver version: 11-44, dyadic strain subscale: higher scores indicate greater levels of strain, positive dyadic interaction subscale: higher scores indicate greater levels of positive interaction |
0 weeks, 6 weeks, 3 months
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Demographic Factors (potential moderators)
Ramy czasowe: 0 weeks
|
Age; biological sex; gender; race/ethnicity; educational level; employment status; occupation; income; marital status; prior ANI status; mental health history; psychotropic medications; medical comorbidities; satisfaction with medical staff (analog scale 0-10) |
0 weeks
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Change in Independence in activities of daily living (potential moderator)
Ramy czasowe: 0 weeks, 6 weeks, 3 months
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Barthel Score; 0-100, higher scores indicate greater independence |
0 weeks, 6 weeks, 3 months
|
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Change in Degree of disability or dependence (potential moderator)
Ramy czasowe: 0 weeks, 6 weeks, 3 months
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Modified Rankin; 0-6, higher scores indicate greater disability |
0 weeks, 6 weeks, 3 months
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2021P001943
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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