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CompletedNCT03429686DTRUpdated May 2, 2018

Digital Reminiscence for People With Dementia

An interventional study of DRT Intervention in Dementia, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2018-05-02.

Sponsored by University of Nottingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Dementia

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Keywords

  • dementia
  • reminiscence therapy
  • touch screen technology
  • digital reminiscence therapy
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    DRT Intervention

    Intervention: Individual digital reminiscence therapy programme.

    Other: DRT Intervention

Interventions

  • OtherDRT 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.

    Also known as: Digital Reminiscence Therapy Intervention

05

What researchers measure

Primary outcomes

  1. Feasibility of the digital reminiscence therapy for PwD

    Assessed by recruitment rate

    Time frame: 3 months

Secondary outcomes

  1. Acceptability of the digital reminiscence therapy for PwD

    Assessed by qualitative interview data - analysis will determine participant enjoyment of the intervention, barriers to programme use, and reasons for non-adherence and attrition

    Time frame: 3 months

  2. Adherence to intervention

    Assessed by adherence rate (number of sessions completed)

    Time frame: 3 months

  3. Study attrition

    Assessed by % lost to attrition

    Time frame: 3 months

  4. Explore whether outcome measures are sensitive to change - for memory

    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.

    Time frame: 3 months

  5. Explore whether outcome measures are sensitive to change - for quality of life

    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.

    Time frame: 3 months

  6. Explore whether outcome measures are sensitive to change - for anxiety and depression

    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.

    Time frame: 3 months

  7. Explore whether outcome measures are sensitive to change - for communication

    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.

    Time frame: 3 months

06

Study locations

1 site
  • University of Nottingham
    Nottingham, NG7 2UH, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03429686
Lead sponsor
University of Nottingham
Responsible party
Holly Blake (Associate Professor of Behavioural Science, Faculty of Medicine & Health Sciences, University of Nottingham) — Principal investigator
First posted
Feb 12, 2018
Start date
Nov 28, 2017
Primary completion
Feb 28, 2018
Completion
Feb 28, 2018
Last update
May 2, 2018

Study contacts

Holly Blake, Dr
principal investigator · University of Nottingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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