- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03429686
Digital Reminiscence for People With Dementia (DTR)
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:
- To determine whether DTR can be delivered as planned in the care of PwD in Jordanian care homes.
- To determine whether DTR is acceptable/tolerable to PwD and care home staff in Jordanian care homes
- 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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nottingham, United Kingdom, NG7 2UH
- University of Nottingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: DRT Intervention
Intervention: Individual digital reminiscence therapy programme.
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Investigators
- Principal Investigator: Holly Blake, Dr, University of Nottingham
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110-1709
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Dementia
-
Benjamin Rose Institute on AgingNational Institute on Aging (NIA)RecruitingMild Dementia | Moderate DementiaUnited States
-
Yaolin PeiNational Institutes of Health (NIH)RecruitingEnd of Life Decision Making | Dementia Caregivers | Advanced DementiaUnited States
-
Benuvia Therapeutics Inc.MandaraNot yet recruiting
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityCompletedDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeActive, not recruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
The University of Hong KongNot yet recruiting
-
Temple UniversityCompletedDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
Clinical Trials on DRT Intervention
-
Auburn UniversityCompletedBullying of ChildUnited States
-
Stanford UniversityTerminatedAutism Spectrum Disorder | AutismUnited States
-
Umraniye Education and Research HospitalUnknownThyroid Neoplasms | Thyroid Cancer | Thyroiditis | Thyroid Goiter | Dysphagia, Oral Phase | Dysphagia, Esophageal | Dysphagia Comes and Goes | Thyroid Nodule (Benign)Turkey
-
Stanford UniversityJohn and Marcia Goldman FoundationNot yet recruitingAutism | Autism Spectrum Disorder (ASD)United States
-
University of Central FloridaEnrolling by invitation
-
NYU Langone HealthCompletedParkinson's Disease | Tremor, EssentialUnited States
-
Universidade Federal de PernambucoNot yet recruitingGastroesophageal Reflux Disease (GERD)Brazil
-
University of Massachusetts, WorcesterHarvard Medical School (HMS and HSDM); National Institute of Mental Health... and other collaboratorsRecruitingMental Health Disorder | Opioid Use DisorderUnited States
-
NYU Langone HealthArthritis FoundationCompletedRheumatoid ArthritisUnited States
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada