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Trial record 1 of 23 for:    reminiscence therapy | Dementia
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Digital Reminiscence for People With Dementia (DTR)

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ClinicalTrials.gov Identifier: NCT03429686
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Holly Blake, University of Nottingham

Brief Summary:

The purpose of this study is to explore the feasibility and acceptability of a digital reminiscence therapy (DRT) intervention for people with dementia (PwD). The objectives of this study include:

  1. To determine whether DTR can be delivered as planned in the care of PwD in Jordanian care homes.
  2. To determine whether DTR is acceptable/tolerable to PwD and care home staff in Jordanian care homes
  3. To identify the most appropriate outcome measures to evaluate the delivery of DRT to PwD in Jordanian care homes to be used in a subsequent definitive trial.

Condition or disease Intervention/treatment Phase
Dementia Other: DRT Intervention Not Applicable

Detailed Description:

Reminiscence Therapy has been shown to be beneficial for people with dementia. The aim of this research is to develop and evaluate the feasibility of a digital application to aid reminiscence for people with dementia.

This study proposes to design an application, based upon reminiscence therapy, which can act as storage for personal and communal 'positive memories' in a range of media types. This includes pictures, videos and audio.

The target for this application is people with dementia and their staff caregivers. The study aims to recruit 40-50 participants (40 PwD and 10 staff caregivers). This research will look at the requirements for developing and evaluating a mobile application to see whether it might be used to aid reminiscence for people with dementia. Additionally, this research will ensure whether this digital reminiscence therapy can be delivered and accepted as planned in the care of people with dementia in Jordanian care homes. The acceptance of this digital reminiscence therapy will be assessed by using semi-structured interviews with approximately 15 people with dementia and staff care-givers. Quantitative measures will be used before and after the intervention to explore whether certain outcomes are sensitive to change. These outcomes include memory, communication, anxiety, depression, and quality of life.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A single group pre-post intervention feasibility study with process evaluation. Data will be collected from residents and staff in Jordanian care homes through questionnaires, from care home records, and qualitative interviews.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Digital Technology in Reminiscence Work With People With Dementia in Jordanian Care Homes: A Feasibility Study
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: DRT Intervention
Intervention: Individual digital reminiscence therapy programme.
Other: DRT Intervention
The digital reminiscence therapy intervention will run 12 sessions twice per week, for six weeks, for up to an hour at a time (this will depend on the participant's ability and willingness to participate). The sessions of reminiscence therapy will be culturally appropriate and based on the key stages in the life which most people will have experienced. These sessions are individual, face-to-face sessions.
Other Name: Digital Reminiscence Therapy Intervention




Primary Outcome Measures :
  1. Feasibility of the digital reminiscence therapy for PwD [ Time Frame: 3 months ]
    Assessed by recruitment rate


Secondary Outcome Measures :
  1. Acceptability of the digital reminiscence therapy for PwD [ Time Frame: 3 months ]
    Assessed by qualitative interview data - analysis will determine participant enjoyment of the intervention, barriers to programme use, and reasons for non-adherence and attrition

  2. Adherence to intervention [ Time Frame: 3 months ]
    Assessed by adherence rate (number of sessions completed)

  3. Study attrition [ Time Frame: 3 months ]
    Assessed by % lost to attrition

  4. Explore whether outcome measures are sensitive to change - for memory [ Time Frame: 3 months ]

    Pre-post changes in Arabic Version of Saint-Louis-University-Mental-Status (SLUMS; Abdelrahman & El Gaafary, 2014) it is a 30-point, 11 questions. The maximum score is 30 points.

    Cut-off scores based on high School Education:

    21-26 = Mild Neurocognitive Impairment, 1-20 = Dementia.

    Less than High School Education:

    20-24 = Mild Neurocognitive Impairment, 1-19 = Dementia.


  5. Explore whether outcome measures are sensitive to change - for quality of life [ Time Frame: 3 months ]
    Older People's Quality of Life Questionnaire (OPQOL-brief-13; Bowling et al., 2012) Each of the 13 items is scored from 1 to 5. The items are summed for a total OPQOL-Brief, then positive items are reverse coded, so that higher scores represented higher QoL.

  6. Explore whether outcome measures are sensitive to change - for anxiety and depression [ Time Frame: 3 months ]
    Arabic version of Hospital Anxiety and Depression Scale (Arabic HADS; Al Aseri et al., 2015) it comprises 7 questions for anxiety and 7 questions for depression. each subscale is ranged from 0 to 3. Cut-off scores for both is 8 separately; 8-10: mild, 11-14: moderate, 15-21: severe.

  7. Explore whether outcome measures are sensitive to change - for communication [ Time Frame: 3 months ]
    Holden Communication Scale for Persons with Dementia (HCS; Strøm et al., 2016). it includes 12 items. each subscale is scored from 0 to 4. The total scores range from 0-48 and the higher score the more difficulties.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • People who have been clinically diagnosed with dementia determined by psychiatrist in the selected care homes. The diagnosis will be recorded in their care home notes.
  • People who are residents in the designated care home and they are anticipated to be resident in the care home for the coming year.
  • People who have the capacity to understand and consent to participate in the study (including those who can consent in the moment), OR they will have a consultee who can be approached for their assent if they are not able to consent in the moment but meet the eligibility criteria.

Exclusion Criteria:

  • People who are deemed too unwell to participate determined by care home staff.
  • People with a diagnosis of an additional psychiatric disorder other that those identified in the inclusion criteria (e.g. schizophrenia, MDD) determined by care home staff.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429686


Locations
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United Kingdom
University of Nottingham
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Holly Blake, Dr University of Nottingham
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Responsible Party: Holly Blake, Associate Professor of Behavioural Science, Faculty of Medicine & Health Sciences, University of Nottingham
ClinicalTrials.gov Identifier: NCT03429686    
Other Study ID Numbers: 110-1709
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holly Blake, University of Nottingham:
dementia
reminiscence therapy
touch screen technology
digital reminiscence therapy
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders