Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
11 апреля 2019 г. обновлено: Douglas L. Weeks, St. Luke's Rehabilitation Institute
Each year over 12,000 spinal cord injuries (SCI) occur in the United States.
These injuries result in incredibly difficult, long-term, life adjustments both for patients and their caregivers.
Many families continue to struggle with the physical, emotional and social impacts of SCI for months and years after the injury.
Family education and support improves the outcomes of other challenging long-term conditions such as Traumatic Brain Injury, but little effort has been made to provide such interventions for persons with SCI and their caregivers.
The proposed study will address this problem by refining and testing a group treatment for SCI called Multi-family Group (MFG) intervention.
The groups will include people with SCI and their primary caregivers, and will be facilitated by an "educator" who is a health care provider who works with people with SCI.
By providing education about the management of SCI and support in an MFG format, quality of life for persons with SCI is predicted to be improved.
In turn, it is expected that caregivers will also benefit from the information, problem-solving activities, and social support that they receive from the educators and other group members.
The investigators will recruit 32 individuals with SCI who have been discharged from inpatient rehabilitation within the previous three years and their primary caregivers.
Participants will be randomized to the MFG intervention or to an education control condition and tested before and after treatment and 6 months following treatment.
It is hypothesized that participants receiving MFG-SCI will have better outcomes than controls on measures of quality of life, health, and adjustment.
The study will also test whether participants who are more recently discharged from inpatient rehabilitation will experience greater benefit from the MFG intervention or the education control intervention.
If the outcomes support the hypotheses, the MFG intervention should be made available to those with SCI and their caregivers.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
38
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
Washington
-
Spokane, Washington, Соединенные Штаты, 99202
- St. Luke's Rehabilitation Institute
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- For Person with SCI: quadriplegia or paraplegia due to an acquired injury with complete or incomplete lesion as defined by ASIA
- For person with SCI: discharge from inpatient rehabilitation within the previous 3 years
- For Person with SCI: age 18 years or older
- For Person with SCI: mobility impairment as the result of the SCI
- For Person with SCI: living in the community in a non-group setting after injury
- For Person with SCI: planning to remain in the geographic area for at least 12 months
- For Person with SCI: competency in English
- For Caregiver of Person with SCI: provision of instrumental or emotional support for a spouse, relative, partner, or friend with SCI for at least the past 6 months
- For Caregiver of Person with SCI: having regular contact with the individual with SCI (at least a minimum of 2 hours face-to-face contact per week)
- For Caregiver of Person with SCI: living with or near the individual with SCI
- For Caregiver of Person with SCI: over the age of 18
- For Caregiver of Person with SCI: having a telephone
- For Caregiver of Person with SCI: planning to remain in the geographic area for at least 12 months
- For Caregiver of Person with SCI: competency in English
Exclusion Criteria:
- For Person with SCI or Caregiver: terminal illness with life expectancy of less than 12 months
- For Person with SCI or Caregiver: in active treatment for cancer
- For Person with SCI or Caregiver: blind or deaf
- For Person with SCI or Caregiver: moderate to severe cognitive impairment (defined at screening as a score on the Short Portable Mental Status Questionnaire > 4 errors)
- For Person with SCI or Caregiver: severely high level of depression symptoms (defined at screening as a score on the CES-D >30)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: SCI Education Control Group
The SCIEC condition is a 16-session, highly structured educational intervention that provides information on how SCI affects the body; methods for maximizing function, coping, and living with SCI; and staying healthy with SCI.
It also includes general guidelines for improving health behavior.
Each SCIEC session follows the same structure, beginning with a presentation of the objectives for the current session and a brief review of material from the previous session before introducing the session's topic and presenting information on one or two key problem areas.
SCIEC utilizes a traditional didactic model with information delivered by an expert SCI educator in a classroom or lecture setting.
|
|
|
Экспериментальный: Multi-family Group Treatment
The MFG Program uses a structured problem-solving and skills training program to provide participants with SCI and their caregivers with tools and information to improve coping and help family members to connect through positive behavioral exchanges.
MFG educators are health professionals with experience in management of SCI, such as physical therapists, recreational therapists, occupational therapists, and psychologists.
MFG will last for 16 sessions across 9 months.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in ability to take action to improve one's health from baseline to end of treatment
Временное ограничение: 9 months
|
Ability to take action to improve one's health will be assessed with the Patient Activation Measure (PAM) and the 8-item Short-Form Health Survey (SF-8).
The PAM will measure the degree of individual's knowledge, confidence, and skill to participate in self-management.
A higher degree of patient activation has been associated with better health outcomes for adults with chronic conditions.
The SF-8 will assess self-reported general health, physical functioning, role-limitations due to physical health problems, bodily pain, and vitality.
|
9 months
|
|
Change in emotion regulation and interpersonal skills from baseline to end of treatment
Временное ограничение: 9 months
|
Emotion regulation and interpersonal skills will be assessed with the Anger Expression Scale (AXS), the Abbreviated Duke Social Support Index (ADSSI), and the Family Crisis Oriented Personal Evaluation Scales (F-COPES).
The AXS measures anger management including anger-in (suppression of angry feelings), anger-out (expression of anger towards property or people) and anger control (the frequency of attempts to control expressions of anger).
The ADSSI measures both subjective support and social network interactions.
The F-COPES assesses family-level coping including use of social/spiritual support, reframing negative events, and mobilizing the family to acquire/accept help.
|
9 months
|
|
Change in mental health and health behavior from baseline to end of treatment
Временное ограничение: 9 months
|
Mental health and health behavior will be assessed for the presence and severity of depressive symptoms, substance use, and in caregivers, burden of care, as these may influence benefits derived from treatment.
The 10-item Center for Epidemiologic Study of Depression (CESD-10) will measure depressive symptoms, and the Addiction Severity Index-Lite (ASI-L) will evaluate alcohol and substance use and related problems.
The Caregiver Burden Inventory (CBI) will evaluate caregiver burden in four areas: physical, social, emotional and time dependence burden.
|
9 months
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in ability to take action to improve one's health from baseline to 6-months post-treatment
Временное ограничение: 15 months
|
Ability to take action to improve one's health will be assessed with the Patient Activation Measure (PAM) and the 8-item Short-Form Health Survey (SF-8).
The PAM will measure the degree of individual's knowledge, confidence, and skill to participate in self-management.
A higher degree of patient activation has been associated with better health outcomes for adults with chronic conditions.
The SF-8 will assess self-reported general health, physical functioning, role-limitations due to physical health problems, bodily pain, and vitality.
|
15 months
|
|
Change in emotion regulation and interpersonal skills from baseline to 6-months post-treatment
Временное ограничение: 15 months
|
Emotion regulation and interpersonal skills will be assessed with the Anger Expression Scale (AXS), the Abbreviated Duke Social Support Index (ADSSI), and the Family Crisis Oriented Personal Evaluation Scales (F-COPES).
The AXS measures anger management including anger-in (suppression of angry feelings), anger-out (expression of anger towards property or people) and anger control (the frequency of attempts to control expressions of anger).
The ADSSI measures both subjective support and social network interactions.
The F-COPES assesses family-level coping including use of social/spiritual support, reframing negative events, and mobilizing the family to acquire/accept help.
|
15 months
|
|
Change in mental health and health behavior from baseline to 6-months post-treatment
Временное ограничение: 15 months
|
Mental health and health behavior will be assessed for the presence and severity of depressive symptoms, substance use, and in caregivers, burden of care, as these may influence benefits derived from treatment.
The 10-item Center for Epidemiologic Study of Depression (CESD-10) will measure depressive symptoms, and the Addiction Severity Index-Lite (ASI-L) will evaluate alcohol and substance use and related problems.
The Caregiver Burden Inventory (CBI) will evaluate caregiver burden in four areas: physical, social, emotional and time dependence burden.
|
15 months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Dennis G. Dyck, PhD, Washington State University
- Главный следователь: Douglas L. Weeks, PhD, St. Luke's Rehabilitation Institute
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Dyck DG, Weeks DL, Smith CL, Shaw M. Multiple family group intervention for spinal cord injury: Quantitative and qualitative comparison with standard education. J Spinal Cord Med. 2021 Jul;44(4):572-582. doi: 10.1080/10790268.2019.1710946. Epub 2020 Jan 21.
- Dyck DG, Weeks DL, Gross S, Lederhos Smith C, Lott HA, Wallace AJ, Wood SM. Comparison of two psycho-educational family group interventions for improving psycho-social outcomes in persons with spinal cord injury and their caregivers: a randomized-controlled trial of multi-family group intervention versus an active education control condition. BMC Psychol. 2016 Jul 26;4(1):40. doi: 10.1186/s40359-016-0145-0.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 сентября 2014 г.
Первичное завершение (Действительный)
1 апреля 2019 г.
Завершение исследования (Действительный)
1 апреля 2019 г.
Даты регистрации исследования
Первый отправленный
6 июня 2014 г.
Впервые представлено, что соответствует критериям контроля качества
10 июня 2014 г.
Первый опубликованный (Оценивать)
12 июня 2014 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
16 апреля 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 апреля 2019 г.
Последняя проверка
1 апреля 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CHNF-288318
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .