Dementia Clinical Trial
— DTROfficial title:
The Use of Digital Technology in Reminiscence Work With People With Dementia in Jordanian Care Homes: A Feasibility Study
| Verified date | May 2018 |
| Source | University of Nottingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Nottingham | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nottingham |
United Kingdom,
| 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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