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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341271
• Other study ID #: FJU-IRB C110100
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2022
• Source: National Taipei University of Nursing and Health Sciences
• Contact: Chia-Jung Hsieh, PhD
• Phone: +886(2)2822-7101
• Email: chiajung[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: July 31, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• The conditions for accepting cases for families with dementia are as follows:

1. Family caregivers must meet the following conditions:

?Age 20 years old or above

?Have 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

2. Dementia patients must meet the following conditions:

• Those who currently live at home and regularly go to the Rizhao Center to participate in activities ?Patients 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 ? Those who have a clear consciousness, can express in Chinese and Taiwanese, or communicate with others in words without hindrance ? 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:

1. The exclusion conditions for family caregivers are:

• A history of mental illness diagnosed by a psychiatrist, such as major depression ? Those who are not of their own nationality.

2. The exclusion conditions for patients with dementia are:

• Confusion or delirium ? Dementia cases who will be referred to long-term care institutions or nursing homes within one month.

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Taiwan	National Taipei University of Nursing and Health Sciences	Taipei	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

References & Publications (35)

Bejan A, Gündogdu R, Butz K, Müller N, Kunze C, König 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 — View Citation

BUTLER RN. The life review: an interpretation of reminiscence in the aged. Psychiatry. 1963 Feb;26:65-76. — View Citation

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. — View Citation

Davison 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 — View Citation

Etters 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. Review. — View Citation

Folstein 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. — View Citation

Fuh 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. — View Citation

GBD 2016 Dementia Collaborators. Global, regional, and national burden of Alzheimer's disease and other dementias, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Jan;18(1):88-106. doi: 10.1016/S1474-4422( — View Citation

Huang 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 — View Citation

Joddrell 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. Review. — View Citation

Jones 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. [Epub ahead of print] — View Citation

Ko 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. — View Citation

Laver 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 pract — View Citation

Lazar 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. Review. — View Citation

Liu 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. — View Citation

Lorenz 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: 10.1177/14713012176916 — View Citation

Marshall F, Gordon A, Gladman JRF, Bishop S. Care homes, their communities, and resilience in the face of the COVID-19 pandemic: interim findings from a qualitative study. BMC Geriatr. 2021 Feb 5;21(1):102. doi: 10.1186/s12877-021-02053-9. — View Citation

Martinsson L, Strang P, Bergström J, Lundström S. Dying from COVID-19 in nursing homes-sex differences in symptom occurrence. BMC Geriatr. 2021 May 6;21(1):294. doi: 10.1186/s12877-021-02228-4. — View Citation

McCauley CO, Bond RB, Ryan A, Mulvenna MD, Laird L, Gibson A, Bunting B, Ferry F, Curran K. Evaluating User Engagement with a Reminiscence App Using Cross-Comparative Analysis of User Event Logs and Qualitative Data. Cyberpsychol Behav Soc Netw. 2019 Aug; — View Citation

Moon S, Park K. The effect of digital reminiscence therapy on people with dementia: a pilot randomized controlled trial. BMC Geriatr. 2020 May 6;20(1):166. doi: 10.1186/s12877-020-01563-2. — View Citation

Neal I, du Toit SHJ, Lovarini M. The use of technology to promote meaningful engagement for adults with dementia in residential aged care: a scoping review. Int Psychogeriatr. 2020 Aug;32(8):913-935. doi: 10.1017/S1041610219001388. Epub 2019 Sep 24. Revie — View Citation

Park K, Lee S, Yang J, Song T, Hong GS. A systematic review and meta-analysis on the effect of reminiscence therapy for people with dementia. Int Psychogeriatr. 2019 Nov;31(11):1581-1597. doi: 10.1017/S1041610218002168. Epub 2019 Feb 4. — View Citation

Penning MJ, Wu Z. Caregiver Stress and Mental Health: Impact of Caregiving Relationship and Gender. Gerontologist. 2016 Dec;56(6):1102-1113. Epub 2015 Apr 17. — View Citation

Robinson L, Clare L, Evans K. Making sense of dementia and adjusting to loss: psychological reactions to a diagnosis of dementia in couples. Aging Ment Health. 2005 Jul;9(4):337-47. — View Citation

Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24. — View Citation

Stinson CK. Structured group reminiscence: an intervention for older adults. J Contin Educ Nurs. 2009 Nov;40(11):521-8. doi: 10.3928/00220124-20091023-10. — View Citation

Subramaniam P, Woods B. Digital life storybooks for people with dementia living in care homes: an evaluation. Clin Interv Aging. 2016 Sep 16;11:1263-1276. eCollection 2016. — View Citation

Tuijt R, Frost R, Wilcock J, Robinson L, Manthorpe J, Rait G, Walters K. Life under lockdown and social restrictions - the experiences of people living with dementia and their carers during the COVID-19 pandemic in England. BMC Geriatr. 2021 May 10;21(1): — View Citation

Wang JJ. Group reminiscence therapy for cognitive and affective function of demented elderly in Taiwan. Int J Geriatr Psychiatry. 2007 Dec;22(12):1235-40. — View Citation

Whitehead BR, Torossian E. Older Adults' Experience of the COVID-19 Pandemic: A Mixed-Methods Analysis of Stresses and Joys. Gerontologist. 2021 Jan 21;61(1):36-47. doi: 10.1093/geront/gnaa126. — View Citation

Woods B, O'Philbin L, Farrell EM, Spector AE, Orrell M. Reminiscence therapy for dementia. Cochrane Database Syst Rev. 2018 Mar 1;3:CD001120. doi: 10.1002/14651858.CD001120.pub3. Review. — View Citation

Woods RT, Bruce E, Edwards RT, Elvish R, Hoare Z, Hounsome B, Keady J, Moniz-Cook ED, Orgeta V, Orrell M, Rees J, Russell IT. REMCARE: reminiscence groups for people with dementia and their family caregivers - effectiveness and cost-effectiveness pragmati — View Citation

Yeung DY, Chung EKH, Lam AHK, Ho AKK. Effects of subjective successful aging on emotional and coping responses to the COVID-19 pandemic. BMC Geriatr. 2021 Feb 17;21(1):128. doi: 10.1186/s12877-021-02076-2. — View Citation

Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. — View Citation

Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.105 — View Citation

* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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 a 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)
Primary	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)
Primary	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)
Primary	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)
Primary	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 a 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)
Primary	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)
Primary	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)
Primary	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)
Primary	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 a 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)

External Links

•   World Health Organization (2021). Dementia.