跳至主要内容
临床试验/NCT05341271
NCT05341271Unknown不适用

The Effect of Digital Reminiscence Therapy on People With Mild and Moderate Dementia: A Randomized Controlled Trial.

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2022年1月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
186
试验地点
2
主要终点
Cornell Scale for Depression in Dementia; CSDD

研究概览

简要总结

In the post-epidemic era, it is necessary to develop support programs for families with dementia in empirical care. The reminiscence therapy was adopted by patients with mild and moderate dementia those intervention have had good memory stimulation and emotional support effects in the previous studies. However, the application of digital reminiscence therapy that cross spatial and geographic constraints, but related research still has limitations on the knowledge of this topic.

To use the official Line @ account as a media platform to develop a digital reminiscence group program (DRG), and to investigate the effects of mobile-application-based DRG on the psychoneurological symptoms, depression, life meaning and burden of family caregiver in people with mild and moderate dementia (PMMD).

详细描述

In the post-epidemic era, it is necessary to develop support programs for families with dementia in empirical care. The reminiscence therapy was adopted by patients with mild and moderate dementia those intervention have had good memory stimulation and emotional support effects in the previous studies. However, the application of digital reminiscence therapy that cross spatial and geographic constraints, but related research still has limitations on the knowledge of this topic.

To use the official Line @ account as a media platform to develop a digital reminiscence group program (DRG), and to investigate the effects of mobile-application-based DRG on the psychoneurological symptoms, depression, life meaning and burden of family caregiver in people with mild and moderate dementia (PMMD).

This will be the first digital reminiscence group constructed specifically for family's people with mild and moderate dementia in our country. The investigators expected to have a positive effect. It can be used as a reference for the development of empirical care programs for family caregivers with PMMD in the community.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The conditions for accepting cases for families with dementia are as follows:
  • Family caregivers must meet the following conditions:
  • ①Age 20 years old or above
  • ②Have experience in caring for the dementia case in the past year, and live together
  • Have a smart phone and have experience in using line APP
  • Dementia patients must meet the following conditions:
  • Those who currently live at home and regularly go to the Rizhao Center to participate in activities ②Patients with dementia (Alzheimer's disease) diagnosed by a physician with DSM 5 or in line with NINCDS/ADRDA, their CDR score is 1~2 points ③ Those who have a clear consciousness, can express in Chinese and Taiwanese, or communicate with others in words without hindrance ④ Those who have normal vision and hearing, and can operate digital mobile phones or tablets

排除标准

  • The exclusion criteria for families with dementia are:
  • The exclusion conditions for family caregivers are:
  • A history of mental illness diagnosed by a psychiatrist, such as major depression ② Those who are not of their own nationality.
  • The exclusion conditions for patients with dementia are:
  • Confusion or delirium ② Dementia cases who will be referred to long-term care institutions or nursing homes within one month.

结局指标

主要结局

Cornell Scale for Depression in Dementia; CSDD

时间窗: One month after the end of the intervention (T2)

For patients with dementia who cannot communicate properly with others through oral expressions, making it difficult to identify their depressive symptoms, the application of this observation scale can effectively and appropriately detect depression in the elderly with cognitive impairment. The Kappa value of the two-week rater-ask agreement reliability (inter-rater agreement) was .43, indicating that all items were significantly stable; and the Cronbach's alpha of the internal consistency reliability was .84, this scale The source of the assessment was primarily asking the patient's family caregiver.

Purpose in Life Test:

时间窗: One month after the end of the intervention (T2)

This scale is used to assess the extent to which the elderly perceive the meaning and purpose of their life. There are 9 questions in two aspects (personal value and success of children and grandchildren), which are answered on a four-point scale. Among them, questions 5 and 6 are reverse questions. The total score ranges from 9 to 36 points. The higher the total score, the more positive and meaningful the subject feels about life. This scale has content validity completed by experts and scholars, and the internal consistency Cronbach α value of the scale is .75. After factor analysis, the explained variation of the two factors of shaping can reach 54.4%, indicating that this scale has good performance. reliability and validity.

Mini-Mental State Examination; MMSE

时间窗: One month after the end of the intervention (T2)

The content of the test includes orientation, immediate memory, recent memory, concentration or attention, etc. The full score is 30 points. It is currently used in clinical and research, and is often used for cognitive evaluation of the elderly, and is widely used.

Neuropsychiatric Inventory, NPI

时间窗: One month after the end of the intervention (T2)

The content of the scale is to ask primary caregivers about new behaviors or changes in behavior since the onset of the patient, whether in the past four weeks or within a specified period of time. NPI includes 12 psycho-behavioral symptom items. The scoring method first uses screening questions to determine whether there is a change in behavior, then in-depth understanding of the changed behavior, and finally determines the frequency, severity and caregiver distress of the behavior according to each behavior degree. In terms of reliability and validity of the scale, the Cronbach's alpha for Chinese was 0.76, and the test-retest reliabilities of severity frequency and caregiver stress in the scale were 0.82, 0.85 and 0.79 respectively. It also has good reliability and validity (Fuh, Liu, Mega, Wang, \& Cummings, 2001), and the assessment source of this scale is mainly asking the family caregivers of the patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chia Jung Hsieh

Ph.D., RN, Associate Professor

National Taipei University of Nursing and Health Sciences

研究点 (2)

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