DEM, Dementia, Dementia Frontal, Dementia, Mixed, Dementia Moderate, Dementia of Alzheimer Type, Dementia Severe, Dementia, Vascular, Dementia With Lewy Bodies
Conditions
Keywords
Dementia, Randomized Controlled Trial, Cognitive Stimulation, Moderate to severe dementia
Brief summary
This study is a feasibility randomised controlled trial (RCT) for an evidence-based intervention for people with moderate to severe dementia. The psychosocial intervention is adapted from Cognitive Stimulation Therapy (CST) and developed within the Medical Research Council (MRC) framework.
Detailed description
The World Health Organization calls for an increase of psychosocial interventions for dementia-a global epidemic. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the National Institute for Health and Care Excellence for improving cognition for mild to moderate dementia. However, there is little guidance on how to maximise cognition for severe dementia. Advanced Cognitive Stimulation Therapy (ACST) will be the first evidence-based complex intervention for moderate to severe dementia developed within the Medical Research Council (MRC) framework and building upon CST's key principles. This feasibility randomised controlled trial (RCT) aims to 1) evaluate the feasibility of ACST 2) explore if ACST can improve the cognitive function, and QoL, as well as other outcomes including behaviour, engagement, and communication, for people with moderate to severe dementia. A sample of 32 participants will be recruited, where 16 will be randomly allocated to ACST, and 16 to treatment as usual (TAU). Data will be collected pre and post the 7-week intervention period. Improving cognition and QoL for people with moderate to severe dementia is vital because dementia's prevalence is projected to reach 152 million by 2050, resulting in excessive excess disability.
Interventions
OTHERAdvanced Cognitive Stimulation Therapy
An adapted version of Cognitive Stimulation Therapy for people with moderate to severe dementia.
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single-blind. Assessor will be blinded to the study. Due to the nature of the intervention, the facilitator and participants cannot be blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. Diagnosis of dementia, according to the DSM-IV 3. SMMSE ≤ 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 is willing and able to provide written informed consent if the 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 the researcher or attending care home staff) 2. SMMSE \< 5 3. Participation in other psychosocial intervention studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment (feasibility of ACST) | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period. |
| Retention rate (feasibility of ACST) | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | Retention rate of at least 75% of participants at 8-week follow-up. |
| Negative or adverse events (acceptability of ACST) | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | Any negative or adverse events related to the intervention |
| Intervention fidelity (acceptability of ACST) | Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years | Facilitator's completion of the fidelity checklist following each session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in engagement | Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months | 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. |
| Change in cognitive function | Pre test (baseline: week 0) and post test (week 8) | 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. |
| Change in overall well-being | Evaluated by assessor through video recordings for every session; through study completion, 2 years | 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. |
| Change in quality of life | Pre test (baseline: week 0) and post test (week 8) | 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. |
| Change in behaviour | Pre test (baseline: week 0) and post test (week 8) | Exploratory secondary outcome; measured pre and post test with the Neuropsychiatric Inventory (Cummings et al., 1997). NPI 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. |
| Change in communication abilities | Pre test (baseline: week 0) and post test (week 8) | 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. |
Contacts
Primary ContactEsther K Hui, BSc
Outcome results
None listed