DementiaNCT05341271
The Effect of Digital Reminiscence Therapy on People With Mild and Moderate Dementia
A study testing Experimental: digital reminiscence group (DRG) and Experimental: general reminiscence group (GRG) in people with Dementia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Experimental: digital reminiscence group (DRG) and Experimental: general reminiscence group (GRG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Jan 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taipei University of Nursing and Health Sciences
Taipei, Taipei City, 112303
Chia-Jung Hsieh, PhD, +886(2)2822-7101 ext. 3135, chiajung@ntunhs.edu.tw
Yi-Zhu Wang, BSN, +886(2)2822-7101 ext. 3135, reslisa127@gmail.com
About this study
Official title: The Effect of Digital Reminiscence Therapy on People With Mild and Moderate Dementia: A Randomized Controlled Trial.
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).
Read the 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.
- Conditions
- Dementia
- Being tested
- Experimental: digital reminiscence group (DRG), Experimental: general reminiscence group (GRG)
- Keywords
- dementia, digital technology, reminiscence group, neuropsychiatric symptoms, depression, life meaning, caregiver burden
- Medical subject headings
- Dementia, Depression, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: digital reminiscence group (DRG)Other
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
Experimental: general reminiscence group (GRG)Other
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
| Study group | Role | What they receive |
|---|---|---|
| digital reminiscence group (DRG) | Other | 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. Receives: Other: Experimental: digital reminiscence group (DRG) |
| general reminiscence group (GRG) | Other | 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 Receives: Other: Experimental: general reminiscence group (GRG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One month after the end of the intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start21 Jan 2022
- Primary completion20 Jan 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia Jung Hsieh, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341271
- Sponsor's protocol ID
- FJU-IRB C110100
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
PubMed 7991117Bejan A, Gundogdu R, Butz K, Muller N, Kunze C, Konig P. Using multimedia information and communication technology (ICT) to provide added value to reminiscence therapy for people with dementia : Lessons learned from three field studies. Z Gerontol Geriatr. 2018 Jan;51(1):9-15. doi: 10.1007/s00391-017-1347-7. Epub 2017 Dec 7.
PubMed 29218401BUTLER RN. The life review: an interpretation of reminiscence in the aged. Psychiatry. 1963 Feb;26:65-76. doi: 10.1080/00332747.1963.11023339. No abstract available.
PubMed 14017386Davison TE, Nayer K, Coxon S, de Bono A, Eppingstall B, Jeon YH, van der Ploeg ES, O'Connor DW. A personalized multimedia device to treat agitated behavior and improve mood in people with dementia: A pilot study. Geriatr Nurs. 2016 Jan-Feb;37(1):25-9. doi: 10.1016/j.gerinurse.2015.08.013. Epub 2015 Sep 26.
PubMed 26412509Etters L, Goodall D, Harrison BE. Caregiver burden among dementia patient caregivers: a review of the literature. J Am Acad Nurse Pract. 2008 Aug;20(8):423-8. doi: 10.1111/j.1745-7599.2008.00342.x.
PubMed 18786017Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Fuh JL, Liu CK, Mega MS, Wang SJ, Cummings JL. Behavioral disorders and caregivers' reaction in Taiwanese patients with Alzheimer's disease. Int Psychogeriatr. 2001 Mar;13(1):121-8. doi: 10.1017/s1041610201007517.
PubMed 11352329Huang HC, Chen YT, Chen PY, Huey-Lan Hu S, Liu F, Kuo YL, Chiu HY. Reminiscence Therapy Improves Cognitive Functions and Reduces Depressive Symptoms in Elderly People With Dementia: A Meta-Analysis of Randomized Controlled Trials. J Am Med Dir Assoc. 2015 Dec;16(12):1087-94. doi: 10.1016/j.jamda.2015.07.010. Epub 2015 Sep 1.
PubMed 26341034Joddrell P, Astell AJ. Studies Involving People With Dementia and Touchscreen Technology: A Literature Review. JMIR Rehabil Assist Technol. 2016 Nov 4;3(2):e10. doi: 10.2196/rehab.5788.
PubMed 28582254Jones C, Sung B, Moyle W. Engagement of a Person with Dementia Scale: Establishing content validity and psychometric properties. J Adv Nurs. 2018 May 17. doi: 10.1111/jan.13717. Online ahead of print.
PubMed 29772602Ko KT, Yip PK, Liu SI, Huang CR. Chinese version of the Zarit caregiver Burden Interview: a validation study. Am J Geriatr Psychiatry. 2008 Jun;16(6):513-8. doi: 10.1097/JGP.0b013e318167ae5b.
PubMed 18515696Laver K, Cumming RG, Dyer SM, Agar MR, Anstey KJ, Beattie E, Brodaty H, Broe T, Clemson L, Crotty M, Dietz M, Draper BM, Flicker L, Friel M, Heuzenroeder LM, Koch S, Kurrle S, Nay R, Pond CD, Thompson J, Santalucia Y, Whitehead C, Yates MW. Clinical practice guidelines for dementia in Australia. Med J Aust. 2016 Mar 21;204(5):191-3. doi: 10.5694/mja15.01339.
PubMed 26985848Lazar A, Thompson H, Demiris G. A systematic review of the use of technology for reminiscence therapy. Health Educ Behav. 2014 Oct;41(1 Suppl):51S-61S. doi: 10.1177/1090198114537067.
PubMed 25274711Liu Y, Yan LM, Wan L, Xiang TX, Le A, Liu JM, Peiris M, Poon LLM, Zhang W. Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis. 2020 Jun;20(6):656-657. doi: 10.1016/S1473-3099(20)30232-2. Epub 2020 Mar 19. No abstract available.
PubMed 32199493Lorenz K, Freddolino PP, Comas-Herrera A, Knapp M, Damant J. Technology-based tools and services for people with dementia and carers: Mapping technology onto the dementia care pathway. Dementia (London). 2019 Feb;18(2):725-741. doi: 10.1177/1471301217691617. Epub 2017 Feb 8.
PubMed 28178858
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Digital Reminiscence Therapy on People With Mild and Moderate Dementia: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05341271
- Acronym / sponsor ID
- FJU-IRB C110100
- Conditions
- Dementia
- Keywords
- dementia, digital technology, reminiscence group, neuropsychiatric symptoms, depression, life meaning, caregiver burden
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 20 Jan 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digital reminiscence group (DRG) | Other | Other: Experimental: digital reminiscence group (DRG)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. |
| general reminiscence group (GRG) | Other | Other: Experimental: general reminiscence group (GRG)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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The conditions for accepting cases for families with dementia are as follows:
- ①Age 20 years old or above
- ②Have experience in caring for the dementia case in the past year, and live together
Key exclusion criteria (5 listed)
- The exclusion criteria for families with dementia are:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: digital reminiscence group (DRG)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 | Other | digital reminiscence group (DRG) |
| Experimental: general reminiscence group (GRG)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 | Other | general reminiscence group (GRG) |
Primary outcome
Mini-Mental State Examination; MMSE
Time frame: Pre-intervention(T0)
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
Time frame: Pre-intervention(T0)
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.
Cornell Scale for Depression in Dementia; CSDD
Time frame: Pre-intervention(T0)
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:
Time frame: Pre-intervention(T0)
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
Time frame: two momths after intervention(T1)
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
Time frame: two momths after intervention(T1)
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.
Cornell Scale for Depression in Dementia; CSDD
Time frame: two momths after intervention(T1)
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:
Time frame: two momths after intervention(T1)
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
Time frame: 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
Time frame: 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.
Cornell Scale for Depression in Dementia; CSDD
Time frame: 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:
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Background: PubMed 7991117Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
- Results publication: PubMed 29218401Bejan A, Gundogdu R, Butz K, Muller N, Kunze C, Konig P. Using multimedia information and communication technology (ICT) to provide added value to reminiscence therapy for people with dementia : Lessons learned from three field studies. Z Gerontol Geriatr. 2018 Jan;51(1):9-15. doi: 10.1007/s00391-017-1347-7. Epub 2017 Dec 7.
- Results publication: PubMed 14017386BUTLER RN. The life review: an interpretation of reminiscence in the aged. Psychiatry. 1963 Feb;26:65-76. doi: 10.1080/00332747.1963.11023339. No abstract available.
- Results publication: PubMed 26412509Davison TE, Nayer K, Coxon S, de Bono A, Eppingstall B, Jeon YH, van der Ploeg ES, O'Connor DW. A personalized multimedia device to treat agitated behavior and improve mood in people with dementia: A pilot study. Geriatr Nurs. 2016 Jan-Feb;37(1):25-9. doi: 10.1016/j.gerinurse.2015.08.013. Epub 2015 Sep 26.
- Results publication: PubMed 18786017Etters L, Goodall D, Harrison BE. Caregiver burden among dementia patient caregivers: a review of the literature. J Am Acad Nurse Pract. 2008 Aug;20(8):423-8. doi: 10.1111/j.1745-7599.2008.00342.x.
- Results publication: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Results publication: PubMed 11352329Fuh JL, Liu CK, Mega MS, Wang SJ, Cummings JL. Behavioral disorders and caregivers' reaction in Taiwanese patients with Alzheimer's disease. Int Psychogeriatr. 2001 Mar;13(1):121-8. doi: 10.1017/s1041610201007517.
- Results publication: PubMed 26341034Huang HC, Chen YT, Chen PY, Huey-Lan Hu S, Liu F, Kuo YL, Chiu HY. Reminiscence Therapy Improves Cognitive Functions and Reduces Depressive Symptoms in Elderly People With Dementia: A Meta-Analysis of Randomized Controlled Trials. J Am Med Dir Assoc. 2015 Dec;16(12):1087-94. doi: 10.1016/j.jamda.2015.07.010. Epub 2015 Sep 1.
- Results publication: PubMed 28582254Joddrell P, Astell AJ. Studies Involving People With Dementia and Touchscreen Technology: A Literature Review. JMIR Rehabil Assist Technol. 2016 Nov 4;3(2):e10. doi: 10.2196/rehab.5788.
- Results publication: PubMed 29772602Jones C, Sung B, Moyle W. Engagement of a Person with Dementia Scale: Establishing content validity and psychometric properties. J Adv Nurs. 2018 May 17. doi: 10.1111/jan.13717. Online ahead of print.
- Results publication: PubMed 18515696Ko KT, Yip PK, Liu SI, Huang CR. Chinese version of the Zarit caregiver Burden Interview: a validation study. Am J Geriatr Psychiatry. 2008 Jun;16(6):513-8. doi: 10.1097/JGP.0b013e318167ae5b.
- Results publication: PubMed 26985848Laver K, Cumming RG, Dyer SM, Agar MR, Anstey KJ, Beattie E, Brodaty H, Broe T, Clemson L, Crotty M, Dietz M, Draper BM, Flicker L, Friel M, Heuzenroeder LM, Koch S, Kurrle S, Nay R, Pond CD, Thompson J, Santalucia Y, Whitehead C, Yates MW. Clinical practice guidelines for dementia in Australia. Med J Aust. 2016 Mar 21;204(5):191-3. doi: 10.5694/mja15.01339.
- World Health Organization (2021). Dementia.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: digital reminiscence group (DRG) and Experimental: general reminiscence group (GRG) in people with Dementia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Jung Hsieh, PhD (+886(2)2822-7101 ext. 3135, chiajung@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination; MMSE (time frame: Pre-intervention(T0)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05341271, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.