NCT03429686

Brief 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. 1.To determine whether DTR can be delivered as planned in the care of PwD in Jordanian care homes.
  2. 2.To determine whether DTR is acceptable/tolerable to PwD and care home staff in Jordanian care homes
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

January 24, 2018

Last Update Submit

May 1, 2018

Conditions

Keywords

dementiareminiscence therapytouch screen technologydigital reminiscence therapy

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the digital reminiscence therapy for PwD

    Assessed by recruitment rate

    3 months

Secondary Outcomes (7)

  • Acceptability of the digital reminiscence therapy for PwD

    3 months

  • Adherence to intervention

    3 months

  • Study attrition

    3 months

  • Explore whether outcome measures are sensitive to change - for memory

    3 months

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

    3 months

  • +2 more secondary outcomes

Study Arms (1)

DRT Intervention

EXPERIMENTAL

Intervention: Individual digital reminiscence therapy programme.

Other: DRT Intervention

Interventions

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
DRT Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • People who are deemed too unwell to participate determined by care home staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Holly Blake, Dr

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A single group pre-post intervention feasibility study with process evaluation. Data will be collected from residents and staff in Jordanian care homes through questionnaires, from care home records, and qualitative interviews.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Behavioural Science, Faculty of Medicine & Health Sciences

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 12, 2018

Study Start

November 28, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations