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Набор скоро начнётся NCT06559514

Effect of Psycho-Educational Interventions in Communication Partners of Older Adults With Hearing Impairment

Без фазы С лечением Older Adults Hearing Impairment Nursing Communication Partners

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: Group-based multi-component psychoeducational inventions (GMC-PEIs).
Кому может быть актуально
Состояния в реестре: Older Adults, Hearing Impairment, Nursing, Communication Partners. Базовые параметры: от 18 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
Тайвань
Следующий шаг
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Официальное название

The Effectiveness of Group-based Multi-Component Psycho-Educational Interventions (GMC-PEIs) on Burden, Depression, Coping and Quality of Life in Communication Partners of Older Adults With Hearing Impairment

Обзор

Hearing impairment is a critical health problem throughout the world. In addition, having an impact on the biopsychosocial functioning of older adults, it places enormous stress and burden on communication partners who interact with older adults with hearing impairment every day. These communication partners generally have restrictions to their social lives and an increased communication burden, as well as symptoms of depression and adopting maladaptive coping and poorer quality of life. Therefore, group-based multi-component psycho-educational interventions are recommended. The purposes of this study are to examine the effects of group-based multi-component psycho-educational interventions (GMC-PEIs) on burden, depression, coping and quality of life in communication partners of older adults with hearing impairment. The single-blind, randomized control trial will include communication partners of older adults with hearing impairment. Participants will be randomized to either intervention groups or control groups.

Подробное описание

The study will be an experimental design featuring repeated measures, with data collected from a pretest, a posttest and a follow-up test. An estimated total of 92 participants will be randomly assigned to experimental and control groups. The experimental group will participate in a 6-week group-based multi-component psycho-educational interventions (GMC-PEIs), including provide information on communication skills training, clear speech training, psychosocial support, stress management and successful person testimonial, consisting of 60-minute sessions once per week, while the control group will be put on a waiting-list group. Each group will be assessed of the outcomes at 3 time points: baseline (T0), three months following the intervention (T1) and again at six months following the intervention (T2). The investigators will use the Significant Other Scale for Hearing Disability (SOS-HEAR), the 10-item version of the Center for Epidemiological Studies Depression Scale (10-Item CES-D), the Brief Coping Orientation to Problems Experienced Scale (B-COPE), the Short Form Health Survey (SF-12) and the International Outcome Inventory for Hearing Aids-Significant Other (IOI-HA-SO) as the outcome indicators. The principle of intention-to-treat (ITT) analysis will be used, and the result will be analyzed mainly by generalized estimating equation (GEE).

Вмешательства

  • Поведенческое Group-based multi-component psychoeducational inventions (GMC-PEIs)
    The participants were randomly assigned to either the experimental group, using a computer-generated list of random numbers.

Первичные конечные точки

  • Change from baseline the Significant Other Scale for Hearing Disability, at 3 months, and 6 months. [Срок оценки: baseline, 3th, 6th month]
  • Change from baseline the 10-item version of the Center for Epidemiological Studies Depression Scale at 3 months, and 6 months. [Срок оценки: baseline, 3th, 6th month]
  • Change from baseline the Brief Coping Orientation to Problems Experienced Scale at 3 months, and 6 months. [Срок оценки: baseline, 3th, 6th month]
  • Change from baseline the Short Form Health Survey(SF-12) at 3 months, and 6 months. [Срок оценки: baseline, 3th, 6th month]
  • Change from baseline the International Outcome Inventory for Hearing Aids-Significant Other at 3 months, and 6 months. [Срок оценки: baseline, 3th, 6th month]

Критерии участия

Критерии включения

  • being18 or older
  • living with older adults with hearing impairment
  • they were indicated that as primary communication partner
  • no known hearing loss
  • having normal cognitive function
  • articulate in the Mandarin Chinese language
  • signing a consent form to participate

Критерии исключения

  • severe psychiatric disorders
  • the communication partner who is hired as a caregiver

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

Тайвань · 1 центр
  • National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT06559514 · 202304022RINA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗