Digital Reminiscence for People With Dementia (DTR)

May 1, 2018 updated by: Holly Blake, University of Nottingham

The Use of Digital Technology in Reminiscence Work With People With Dementia in Jordanian Care Homes: A Feasibility Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Digital Reminiscence Therapy Intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of the digital reminiscence therapy for PwD
Time Frame: 3 months
Assessed by recruitment rate
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
3 months
Adherence to intervention
Time Frame: 3 months
Assessed by adherence rate (number of sessions completed)
3 months
Study attrition
Time Frame: 3 months
Assessed by % lost to attrition
3 months
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.
3 months
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.
3 months
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nottingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Holly Blake, Dr, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 110-1709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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