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Advanced Cognitive Stimulation Therapy (ACST)

Primary Purpose

DEM, Dementia, Dementia, Vascular

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Advanced Cognitive Stimulation Therapy
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DEM focused on measuring Dementia, Randomized Controlled Trial, Cognitive Stimulation, Moderate to severe dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Advanced Cognitive Stimulation Therapy

    Treatment as usual

    Arm Description

    Advanced Cognitive Stimulation Therapy (ACST), a psychosocial intervention, is the modified version of CST for people with moderate and severe dementia. Activities consist of more multisensory stimulation elements than the original CST. ACST will be prescribed to participants 45-minutes per week, biweekly for 7 weeks. The intervention will be delivered by two facilitators, such as a research staff, clinical psychologist trainee or care home staff.

    Standard care in care homes

    Outcomes

    Primary Outcome Measures

    Recruitment (feasibility of ACST)
    Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
    Retention rate (feasibility of ACST)
    Retention rate of at least 75% of participants at 8-week follow-up.
    Negative or adverse events (acceptability of ACST)
    Any negative or adverse events related to the intervention
    Intervention fidelity (acceptability of ACST)
    Facilitator's completion of the fidelity checklist following each session
    Intervention fidelity (acceptability of ACST)
    Video recording of all sessions and an independent researcher rating fidelity with a random 10% of the recordings.

    Secondary Outcome Measures

    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.
    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.
    Change in behaviour
    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
    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.
    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.
    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.

    Full Information

    First Posted
    September 1, 2020
    Last Updated
    September 10, 2020
    Sponsor
    University College, London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04550975
    Brief Title
    Advanced Cognitive Stimulation Therapy (ACST)
    Official Title
    Feasibility Randomised Controlled Trial (RCT) of Advanced Cognitive Stimulation Therapy (ACST) for People With Moderate to Severe Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    March 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University College, London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    DEM, Dementia, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies, Dementia Frontal, Dementia Severe, Dementia Moderate, Dementia of Alzheimer Type
    Keywords
    Dementia, Randomized Controlled Trial, Cognitive Stimulation, Moderate to severe dementia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    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
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Advanced Cognitive Stimulation Therapy
    Arm Type
    Experimental
    Arm Description
    Advanced Cognitive Stimulation Therapy (ACST), a psychosocial intervention, is the modified version of CST for people with moderate and severe dementia. Activities consist of more multisensory stimulation elements than the original CST. ACST will be prescribed to participants 45-minutes per week, biweekly for 7 weeks. The intervention will be delivered by two facilitators, such as a research staff, clinical psychologist trainee or care home staff.
    Arm Title
    Treatment as usual
    Arm Type
    No Intervention
    Arm Description
    Standard care in care homes
    Intervention Type
    Other
    Intervention Name(s)
    Advanced Cognitive Stimulation Therapy
    Intervention Description
    An adapted version of Cognitive Stimulation Therapy for people with moderate to severe dementia.
    Primary Outcome Measure Information:
    Title
    Recruitment (feasibility of ACST)
    Description
    Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
    Time Frame
    Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
    Title
    Retention rate (feasibility of ACST)
    Description
    Retention rate of at least 75% of participants at 8-week follow-up.
    Time Frame
    Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
    Title
    Negative or adverse events (acceptability of ACST)
    Description
    Any negative or adverse events related to the intervention
    Time Frame
    Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
    Title
    Intervention fidelity (acceptability of ACST)
    Description
    Facilitator's completion of the fidelity checklist following each session
    Time Frame
    Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
    Title
    Intervention fidelity (acceptability of ACST)
    Description
    Video recording of all sessions and an independent researcher rating fidelity with a random 10% of the recordings.
    Time Frame
    Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
    Secondary Outcome Measure Information:
    Title
    Change in cognitive function
    Description
    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.
    Time Frame
    Pre test (baseline: week 0) and post test (week 8)
    Title
    Change in quality of life
    Description
    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.
    Time Frame
    Pre test (baseline: week 0) and post test (week 8)
    Title
    Change in behaviour
    Description
    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.
    Time Frame
    Pre test (baseline: week 0) and post test (week 8)
    Title
    Change in communication abilities
    Description
    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.
    Time Frame
    Pre test (baseline: week 0) and post test (week 8)
    Title
    Change in engagement
    Description
    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.
    Time Frame
    Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months
    Title
    Change in overall well-being
    Description
    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.
    Time Frame
    Evaluated by assessor through video recordings for every session; through study completion, 2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 Diagnosis of dementia, according to the DSM-IV SMMSE ≤ 12 Ability to communicate in English Ability to complete outcome measures Not having major physical illness or disability that affects participation Consultee is willing and able to provide written informed consent if the participant is not able to provide consent. Ability to remain in a group for around an hour (e.g. no challenging behaviour) Exclusion Criteria: Illness and disability that affects participation (as deemed by the researcher or attending care home staff) SMMSE < 5 Participation in other psychosocial intervention studies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Esther K Hui, BSc
    Phone
    +447460285290
    Email
    esther.hui.19@ucl.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aimee Spector, PhD, DClinPsych
    Organizational Affiliation
    University College, London
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Study results and IPD will be published in a doctoral thesis, peer-reviewed journals, and presented at conferences, and disseminated to the public through information sheets. Participants who indicate their interest in receiving further information regarding dissemination will be sent a letter with the main findings of the study upon completion. Other researchers can email authors for IPD.
    IPD Sharing Time Frame
    Upon study completion
    IPD Sharing Access Criteria
    Email authors
    Citations:
    PubMed Identifier
    9447431
    Citation
    Molloy DW, Standish TI. A guide to the standardized Mini-Mental State Examination. Int Psychogeriatr. 1997;9 Suppl 1:87-94; discussion 143-50. doi: 10.1017/s1041610297004754.
    Results Reference
    background
    PubMed Identifier
    12021425
    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. doi: 10.1097/00006842-200205000-00016.
    Results Reference
    background
    PubMed Identifier
    1634695
    Citation
    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. doi: 10.1111/j.1532-5415.1992.tb02009.x.
    Results Reference
    background
    PubMed Identifier
    9153155
    Citation
    Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
    Results Reference
    background
    PubMed Identifier
    10648298
    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. doi: 10.1097/00019442-200002000-00010.
    Results Reference
    background
    PubMed Identifier
    28214783
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16136845
    Citation
    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. doi: 10.1177/153331750502000406.
    Results Reference
    background
    Citation
    Holden UP, Woods RT. Positive approaches to dementia care. Edinburgh: Churchill Livingstone, 1995.
    Results Reference
    background

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    Advanced Cognitive Stimulation Therapy (ACST)

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