Dementia Clinical Trial
Official title:
Feasibility Randomised Controlled Trial (RCT) of Advanced Cognitive Stimulation Therapy Hong Kong (ACST-HK) for People With Moderate to Severe Dementia
This study is a feasibility randomized controlled trial (RCT) for an evidence-based intervention for people with moderate to severe dementia in Hong Kong. The psychosocial intervention is adapted from Cognitive Stimulation Therapy (CST), translated and adapted for the Hong Kong Chinese population, and developed within the Medical Research Council (MRC) framework.
Status | Not yet recruiting |
Enrollment | 32 |
Est. completion date | November 1, 2022 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age = 18 2. Diagnosis of dementia, according to the DSM-V 3. CMMSE = 12 4. Ability to communicate in English 5. Ability to complete outcome measures 6. Not having major physical illness or disability that affects participation 7. Consultee willing and able to provide written informed consent, if participant is not able to provide consent. 8. Ability to remain in a group for around an hour (e.g. no challenging behaviour) Exclusion Criteria: 1. Illness and disability that affects participation (as deemed by researcher or attending 2. care home staff) 3. CMMSE < 5 4. Participation in other psychosocial intervention studies |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University College, London | The University of Hong Kong |
Albert M, Cohen C. The Test for Severe Impairment: an instrument for the assessment of patients with severe cognitive dysfunction. J Am Geriatr Soc. 1992 May;40(5):449-53. — View Citation
Chiu H, Lee HC, Chung WS, Kwong PK. Reliability and validity of the Cantonese Version of Mini-Mental State Examination - a preliminary study. JHKCPsych. 1994;4(2).
Cohen-Mansfield J, Hai T, Comishen M. Group engagement in persons with dementia: The concept and its measurement. Psychiatry Res. 2017 May;251:237-243. doi: 10.1016/j.psychres.2017.02.013. Epub 2017 Feb 6. — View Citation
Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. Review. — View Citation
Holden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.
Kinney JM, Rentz CA. Observed well-being among individuals with dementia: Memories in the Making, an art program, versus other structured activity. Am J Alzheimers Dis Other Demen. 2005 Jul-Aug;20(4):220-7. — View Citation
Leung VP, Lam LC, Chiu HF, Cummings JL, Chen QL. Validation study of the Chinese version of the neuropsychiatric inventory (CNPI). Int J Geriatr Psychiatry. 2001 Aug;16(8):789-93. — View Citation
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. — View Citation
Wood S, Cummings JL, Hsu MA, Barclay T, Wheatley MV, Yarema KT, Schnelle JF. The use of the neuropsychiatric inventory in nursing home residents. Characterization and measurement. Am J Geriatr Psychiatry. 2000 Winter;8(1):75-83. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment (feasibility of ACST-HK) | Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period. | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | |
Primary | Retention rate (feasibility of ACST-HK) | Retention rate of at least 75% of participants at 8-week follow-up. | Descriptive data will be collected during the study and analysed post-intervention; at 8-week follow-up | |
Primary | Negative of adverse events (acceptability of ACST-HK) | Any negative or adverse events related to the intervention | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | |
Primary | Intervention fidelity (acceptability of ACST-HK) | Facilitator's completion of the fidelity checklist following each session | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | |
Primary | Intervention fidelity (acceptability of ACST-HK) | Video recording of all sessions and an independent researcher rating fidelity with a random 10% of the recordings. | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | |
Secondary | Change in cognitive function | Exploratory primary outcome; measured pre and post intervention with Standardised Mini-Mental State Examination (Molloy & Standish, 1997) and Test for Severe Impairment (Albert & Cohen, 1992). SMMSE has 11 questions with scores from 0 to 30, where a low score indicates poor performance. TSI has six domains: motor performance, language comprehension, language production, memory, general knowledge, and conceptualisation. Each domain has a maximum score of 4, and a higher score indicates better cognitive ability. | Pre test (baseline: week 0) and post test (week 8) | |
Secondary | Change in quality of life | Exploratory primary outcome; measured pre and post test with Quality of Life in Alzheimer's Disease (QoL-AD) (Logsdon et al., 2002). QoL-AD has 13-items, and a sum score range from 13 to 52; higher score denotes better quality of life. | Pre test (baseline: week 0) and post test (week 8) | |
Secondary | Change in behaviour | Exploratory secondary outcome; measured pre and post test with the Cantonese Version of Neuropsychiatric Inventory (CNPI) (Cummings et al., 1997; Leung et al., 2001). CNPI consists of 12 domains. Each question asks for a frequency of symptoms on a 4-point score, severity on a 3-point score, and distress on a 5-point scale. Higher score denotes higher frequency and severity. | Pre test (baseline: week 0) and post test (week 8) | |
Secondary | Change in engagement | Exploratory secondary outcome; measured with the Group Observational Measurement of Engagement Tool (Cohen-Mansfield et al., 2017). GOME consists of 5-domains: attendance, engagement, active participation, attitude, and sleep. Each item is measured on a 4- or 7-point Likert scale from 0, none of the time, to 6, all of the time. | Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months | |
Secondary | Change in overall well-being | Exploratory secondary outcome; measured with the Adapted Greater Cincinnati Chapter Well-Being Observation Tool (Adapted GCCWBOT) (Kinney & Rentz, 2005). The facilitator or independent researcher will assess 4 participants at a time. Each evaluation will be 62 minutes, and 8 domains will be assessed: interest, attention, pleasure, self-esteem, normalcy, disengagement, sadness, and negative affect. | Evaluated by assessor through video recordings for every session; week 1 to until end of study | |
Secondary | Change in communication abilities | Exploratory secondary outcome; measured pre and post test with the Holden Communication Scale (Holden & Woods, 1995). Each item contains is on a 5 point scale, and the questionnaire has a maximum score of 48, where a higher score indicates difficulties in communication. | Pre test (baseline: week 0) and post test (week 8) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05686486 -
Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes
|
N/A | |
Terminated |
NCT05451693 -
Outreach-ER: A Dementia Care Intervention Program
|
||
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Enrolling by invitation |
NCT06040294 -
Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills
|
N/A | |
Completed |
NCT05114187 -
An Internet-Based Education Program for Care Partners of People Living With Dementia
|
N/A | |
Recruiting |
NCT06322121 -
Vascular Aspects in Dementia: Part 2
|
||
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT04426838 -
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
|
N/A | |
Recruiting |
NCT03462485 -
Pilot Study of the Effects of Playing Golf on People With Dementia
|
N/A | |
Active, not recruiting |
NCT03677284 -
Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia
|
N/A | |
Completed |
NCT03849937 -
Changing Talk Online (CHATO) Study
|
N/A | |
Recruiting |
NCT06284213 -
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
|
||
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT05080777 -
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
|
N/A | |
Completed |
NCT04571697 -
A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Recruiting |
NCT06033066 -
Financial Incentives and Recruitment to the APT Webstudy
|
N/A | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT05684783 -
Dementia Champions in Homecare
|
||
Completed |
NCT03147222 -
Function Focused Care: Fracture Care at Home
|
N/A |