The Effect of Digital Reminiscence Therapy on People With Mild and Moderate Dementia

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

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

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Other: Experimental: digital reminiscence group (DRG)
* Other: Experimental: general reminiscence group (GRG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: digital reminiscence group (DRG)<br>Experiment group A accepted the planned digital nostalgic group activities using the official account platform of line as a medium, one class per week, 45-50 minutes each time, lasting 8 times. | Other: Experimental: digital reminiscence group (DRG)<br>* Experiment group A accepted the digital reminiscence group planned by the official account platform of line as the medium, the theme and content, it is planned to consider the development of the life cycle, and the experience of the thematic review will induce the motivation of the participants, since childhood life, study The design of eight unit themes such as stage, work and emotional family and festival life, and special life events; at the same time, it can adapt to the psychological adaptation behavior of the participants, review their life development stages according to the life development process, and pay attention to the interpersonal interaction carried out by the current group Negative emotional or symptomatic behavior with dialogue, and directing and dealing with life experiences<br>|
| Other: general reminiscence group (GRG)<br>Experiment group B participated in a general traditional nostalgic group, using actual nostalgic objects or utensils to carry out nostalgic activities, one class per week, 45-50 minutes each time, lasting 8 times | Other: Experimental: general reminiscence group (GRG)<br>* Experiment group B participated in general reminiscence group (GRG) , using actual nostalgic objects or utensils to carry out activities. The theme and content are intended to be considered in the context of life cycle development, and the experience of thematic retrospectives induces the motivation of participants, since childhood. The design of eight unit themes, including the stage of study, work and emotional family and festival life, and special events in life; at the same time, it can adapt to the psychological adaptation behavior of the participants, review their life development stages according to the life development process, and pay attention to the current group activities. Interpersonal interaction and dialogue, and negative emotional or symptomatic behaviors that guide and process life experiences<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination; MMSE | 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. | Pre-intervention(T0) | 
| Neuropsychiatric Inventory, NPI | 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. | Pre-intervention(T0) | 
| Cornell Scale for Depression in Dementia; CSDD | 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. | Pre-intervention(T0) | 
| Purpose in Life Test: | 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. | Pre-intervention(T0) | 
| Mini-Mental State Examination; MMSE | 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. | two momths after intervention(T1) | 
| Neuropsychiatric Inventory, NPI | 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. | two momths after intervention(T1) | 
| Cornell Scale for Depression in Dementia; CSDD | 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. | two momths after intervention(T1) | 
| Purpose in Life Test: | 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. | two momths after intervention(T1) | 
| Mini-Mental State Examination; MMSE | 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. | One month after the end of the intervention (T2) | 
| Neuropsychiatric Inventory, NPI | 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. | One month after the end of the intervention (T2) | 
| Cornell Scale for Depression in Dementia; CSDD | 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. | One month after the end of the intervention (T2) | 
| Purpose in Life Test: | 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. | One month after the end of the intervention (T2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dementia, digital technology, reminiscence group, neuropsychiatric symptoms, depression, life meaning, caregiver burden