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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03429686
Other study ID # 110-1709
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 28, 2017
Est. completion date February 28, 2018

Study information

Verified date May 2018
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 28, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United Kingdom University of Nottingham Nottingham

Sponsors (1)

Lead Sponsor Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of the digital reminiscence therapy for PwD Assessed by recruitment rate 3 months
Secondary 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 3 months
Secondary Adherence to intervention Assessed by adherence rate (number of sessions completed) 3 months
Secondary Study attrition Assessed by % lost to attrition 3 months
Secondary 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.
3 months
Secondary 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. 3 months
Secondary 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. 3 months
Secondary 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. 3 months
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