Dementia Clinical Trial
Official title:
Pilot Evaluation of Technology-enhanced Horticultural Activities Among the People With Dementia and Their Family Caregivers
Horticultural therapy is one of the effective interventions for the person with dementia(PWD) which could increase their time engaging in leisure activities and decrease their time doing nothing. However, there are some limitations and constraints for PWD to participate in the horticultural therapy especially in the high-density cities (e.g. Hong Kong). This study aims to investigate the feasibility and preliminary effects of adopting home-based technology-enhanced horticultural activities. The program will consist of three face-to-face (F-T-F) horticultural activity training session for a group of 6-8 participants and then biweekly telephone follow-up for 8-week home-based horticultural intervention. Program evaluation will be conducted through focus groups with 15 participants with different levels of stress reduction after the intervention. It is hypothesized that the PWD and their caregiver will have a significant improvement in the cognitive function and behavioral symptoms of the PWD, an increase in the positive caregiving experience in the family caregivers, a reduction of the caregivers' level of stress and depressive symptoms, and enhancement of the quality of life of the family caregivers after the intervention.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 30, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. The PWD 1. Aged 65 or above who had been diagnosed with any type of dementia at the early to moderate stage 2. Are Community-dwelling (i.e., non-institutionalized), 3. Are Able to understand Cantonese and follow simple instruction 2. The family caregivers 1. Aged 18 years or above; 2. the blood or by-marriage relatives (e.g. spouses, siblings, children, and grandchildren) of a person who has been clinically diagnosed with dementia, regardless of its types and these relatives are taking up the caring responsibilities ranging from physical aids to emotional supports, in the form of transportation, financial assistance, personal hygiene, and decision-making.; 3. Providing most of the daily care and support for PWD (daily contact for at least four hours); and 4. Able to speak Cantonese Exclusion Criteria: The PWD and the family caregivers 1. Are diagnosed with a mental disorder such as bipolar disorder, schizophrenia, dementia, or depression; and/or, 2. Are taking anticonvulsants, or any kind of psychotropic drugs, and/or identified with a self-reported suicidal thought or drug abuse in the past 6 months. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Hong Kong Polytechnic Univeristy | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
Chin WY, Choi EP, Chan KT, Wong CK. The Psychometric Properties of the Center for Epidemiologic Studies Depression Scale in Chinese Primary Care Patients: Factor Structure, Construct Validity, Reliability, Sensitivity and Responsiveness. PLoS One. 2015 Aug 7;10(8):e0135131. doi: 10.1371/journal.pone.0135131. eCollection 2015. — View Citation
Chu, L. C., & Kao, H. S. (2005). The moderation of meditation experience and emotional intelligence on the relationship between perceived stress and negative mental health (Vol. 47).
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation
Laver K, Milte R, Dyer S, Crotty M. A Systematic Review and Meta-Analysis Comparing Carer Focused and Dyadic Multicomponent Interventions for Carers of People With Dementia. J Aging Health. 2017 Dec;29(8):1308-1349. doi: 10.1177/0898264316660414. Epub 2016 Jul 25. — View Citation
Leung DY, Lam TH, Chan SS. Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010 Aug 25;10:513. doi: 10.1186/1471-2458-10-513. — View Citation
Lin Y, Lin R, Liu W, Wu W. Effectiveness of horticultural therapy on physical functioning and psychological health outcomes for older adults: A systematic review and meta-analysis. J Clin Nurs. 2022 Aug;31(15-16):2087-2099. doi: 10.1111/jocn.16095. Epub 2021 Oct 24. Review. — View Citation
Lou VW, Lau BH, Cheung KS. Positive aspects of caregiving (PAC): scale validation among Chinese dementia caregivers (CG). Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):299-306. doi: 10.1016/j.archger.2014.10.019. Epub 2014 Nov 7. — View Citation
Lu LC, Lan SH, Hsieh YP, Yen YY, Chen JC, Lan SJ. Horticultural Therapy in Patients With Dementia: A Systematic Review and Meta-Analysis. Am J Alzheimers Dis Other Demen. 2020 Jan-Dec;35:1533317519883498. doi: 10.1177/1533317519883498. Epub 2019 Nov 5. — View Citation
Ng KST, Sia A, Ng MKW, Tan CTY, Chan HY, Tan CH, Rawtaer I, Feng L, Mahendran R, Larbi A, Kua EH, Ho RCM. Effects of Horticultural Therapy on Asian Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Aug 9;15(8). pii: E1705. doi: 10.3390/ijerph15081705. — View Citation
Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007. Review. — View Citation
Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement, 1(3), 385-401.
Van't Leven N, Prick AE, Groenewoud JG, Roelofs PD, de Lange J, Pot AM. Dyadic interventions for community-dwelling people with dementia and their family caregivers: a systematic review. Int Psychogeriatr. 2013 Oct;25(10):1581-603. doi: 10.1017/S1041610213000860. Epub 2013 Jul 24. Review. — View Citation
Wong A, Cheng ST, Lo ES, Kwan PW, Law LS, Chan AY, Wong LK, Mok V. Validity and reliability of the neuropsychiatric inventory questionnaire version in patients with stroke or transient ischemic attack having cognitive impairment. J Geriatr Psychiatry Neurol. 2014 Dec;27(4):247-52. doi: 10.1177/0891988714532017. Epub 2014 Apr 24. — View Citation
Wong A, Nyenhuis D, Black SE, Law LS, Lo ES, Kwan PW, Au L, Chan AY, Wong LK, Nasreddine Z, Mok V. Montreal Cognitive Assessment 5-minute protocol is a brief, valid, reliable, and feasible cognitive screen for telephone administration. Stroke. 2015 Apr;46(4):1059-64. doi: 10.1161/STROKEAHA.114.007253. Epub 2015 Feb 19. — View Citation
Wong A, Xiong YY, Kwan PW, Chan AY, Lam WW, Wang K, Chu WC, Nyenhuis DL, Nasreddine Z, Wong LK, Mok VC. The validity, reliability and clinical utility of the Hong Kong Montreal Cognitive Assessment (HK-MoCA) in patients with cerebral small vessel disease. Dement Geriatr Cogn Disord. 2009;28(1):81-7. doi: 10.1159/000232589. Epub 2009 Aug 11. — View Citation
Yu R, Chau PH, McGhee SM, Cheung WL, Chan KC, Cheung SH, Woo J. Trends in prevalence and mortality of dementia in elderly Hong Kong population: projections, disease burden, and implications for long-term care. Int J Alzheimers Dis. 2012;2012:406852. doi: 10.1155/2012/406852. Epub 2012 Oct 14. — View Citation
Zhao Y, Liu Y, Wang Z. Effectiveness of horticultural therapy in people with dementia: A quantitative systematic review. J Clin Nurs. 2022 Jul;31(13-14):1983-1997. doi: 10.1111/jocn.15204. Epub 2020 Feb 20. Review. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Chinese version of Positive Aspect of Caregiving scale (PAC) | The PAC scale demonstrates the acceptable levels of internal consistency Cronbach's alpha 0.85 among the family caregivers of PWD in Hong Kong. Higher scores indicating more positive self-perceptions of caregiving. Comparisons of changes of Positive Aspect of Caregiving scale (PAC)will be considered as follows: T0 - T1 | At baseline (T0) and 11th week (immediately post- intervention; T1 | |
Primary | The Chinese version of Perceived Stress Scale (PSS) | Perceived Stress Scale contains 10 items with 5-point Likert-type scale rating from 0 (never) to 4 (very often). The total score can range from 0 to 40 with higher scores indicating higher perceived stress. Comparisons of changes of Perceived Stress Scale will be considered as follows: T0 - T1 | At baseline (T0) and 11th week (immediately post- intervention; T1 | |
Primary | The WHOQOL-OLD BREF (HK) | The WHOQOL-OLD BREF (HK) comprised 28 items and each item is rated on a 5-point Likert-type scale that ranged from 1 (very dissatisfied) to 5 (very satisfied), with a higher score indicating a better QoL. Comparisons of changes of The WHOQOL-OLD BREF (HK) will be considered as follows: T0 - T1 | At baseline (T0) and 11th week (immediately post- intervention; T1 | |
Primary | The Chinese version of Center for Epidemiological Studies Depression scale(CESDS) | The Chinese version of Center for Epidemiological Studies Depression scale is a self-reported measure of depression containing 20 items. Comparisons of changes of Center for Epidemiological Studies Depression scale will be considered as follows: T0 - T1 | At baseline (T0) and 11th week (immediately post- intervention; T1 | |
Primary | MoCA-5-min | MoCA-5-min assess participants' cognitive function over the telephone. MoCA-5-min comprises four domains: attention, executive function/language, orientation, and memory.Comparisons of changes of MoCA-5-min will be considered as follows: T0 - T1 | At baseline (T0) and 11th week (immediately post- intervention; T1 | |
Primary | The Chinese version of the Neuropsychiatric Inventory-Questionnaire (NPI-Q) | The Neuropsychiatric Inventory-Questionnaire evaluates the frequency, severity, and caregiver distress of 12 neuropsychiatric symptoms by using a 5-point rating scale..Comparisons of changes of the Neuropsychiatric Inventory-Questionnaire will be considered as follows: T0 - T1 | At baseline (T0) and 11th week (immediately post- intervention; T1 |
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