NCT04026061

Brief Summary

First evaluation of FindMyApps, a tablet intervention consisting of a selection tool for usable apps for self-management and meaningful activities and a training that supports informal carers to help people with dementia to learn how to use the tablet and the tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

October 31, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

July 9, 2019

Last Update Submit

July 18, 2019

Conditions

Keywords

Medical Research FrameworkHand-held touchscreen devicesSelf-managementMeaningful activities

Outcome Measures

Primary Outcomes (4)

  • Self-management abilities people with dementia

    Measured with the revised 30-item Self-Management Ability Scale (SMAS-30). Change/ difference between baseline and post-intervention. It consists of six subscales: Taking Initiative, Self-efficacy, Investing, Positive Perspective, Multifunctionality, and Variety. Each subscale consists of five items scored on a 5-point or 6-point Likert-type scale. A 5-point scale is used for 'Self-efficacy' (1 = I certainly do not think so, 5 = I certainly think so) and 'Positive Perspective' (1 = No!, 5 = Yes!), and a 6-point scale is used for 'Taking Initiative', 'Investing', and 'Multifunctionality' (1 = never, 6 = very often), and 'Variety' (1 = none, 6 = more than six). Item scores are transformed into scores ranging from 0 to 20. Mean subscale scores range from 0 to 100, as does the total score, which is the mean score of the six subscales. A higher score indicates more self-management abilities.

    At baseline and post-intervention at 3 months follow up

  • Participation in daily and social activities people with dementia

    Measured with a short version of the Pleasant Activities List (PAL). Change/ difference between baseline and post-intervention. The PAL was used to assess the frequency and enjoyability of daily and social activities. In this study, the PAL was shortened from its original 139 item to 31 items divided into two subscales: Social Activities (SA), such as visiting family, and Domestic Activities (DA), such as gardening. Shortening was done for two reasons: the length of the original version was thought to be not feasible for the PwDs and a focus on social and domestic activities was more in line with this study. Items relate to the frequency of engagement and the subjective enjoyability, which are scored on a 5-point Likert-type scale ranging from 1 (not at all) to 5 (very much). A higher score indicates that activities are done more often and enjoyed more.

    At baseline and post-intervention at 3 months follow up

  • Participation in daily and social activities people with dementia

    Measured with one item of the Adult Social Care Outcomes Toolkit (ASCOT). Change/ difference between baseline and post-intervention. Responses on this item are given on a scale ranging from 1 ('I have as much social contact as I want with people I like') to 4 ('I have little social contact with people and feel socially isolated'). A higher score indicates less social participation.

    At baseline and post-intervention at 3 months follow up

  • Feeling of competence informal carers

    Measured with the Short Sense of Competence Scale (SSCQ). Change/ difference between baseline and post-intervention.The SSCQ contains of seven statements. Informal caregivers had answered these questions on a 5-point-likert scale which ranges from 'agree very strongly' to 'disagree very strongly'. For feeling of competence, the scores on all items were summed to get a sum-score. The sum-score ranges between 7 and 35 and a higher score indicates a greater feeling of competence.

    At baseline and post-intervention at 3 months follow up

Secondary Outcomes (6)

  • Perceived self-efficacy people with dementia

    At baseline and post-intervention at 3 months follow up

  • Perceived autonomy people with dementia

    At baseline and post-intervention at 3 months follow up

  • Quality of life people with dementia

    At baseline and post-intervention at 3 months follow up

  • Positive care experiences informal carers

    At baseline and post-intervention at 3 months follow up

  • Quality of life informal carers

    At baseline and post-intervention at 3 months follow up

  • +1 more secondary outcomes

Study Arms (2)

FMA group

EXPERIMENTAL

Receiving the FMA training and tool

Behavioral: FMA group

control group

PLACEBO COMPARATOR

Receiving a simple tablet training and some websites

Behavioral: Control group

Interventions

FMA groupBEHAVIORAL

A person-centred, tailored tablet intervention, called FindMyApps (FMA). The intervention consists of the FMA training to use the tablet and the FMA selection tool to help users find apps for self-management and meaningful activities that fit their needs, wishes and abilities

FMA group
Control groupBEHAVIORAL

Receiving an introductory tablet training and some links to websites that recommend usable apps for people with dementia in general

control group

Eligibility Criteria

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

You may qualify if:

  • Eligible dyads had to be community dwelling.
  • Persons with dementia had Mild Cognitive Impairment or mild dementia with a score of 3 to 4 on the Global Deterioration Scale (GDS; 45), with or without a confirmed diagnosis.
  • Availability of an informal carer or volunteer to provide support.

You may not qualify if:

  • Participation in another intervention trial
  • Severe visual and/or physical impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saxion University of applied Sciences

Enschede, Overijssel, 7500 KB, Netherlands

Location

Related Publications (3)

  • Kerkhof Y, Pelgrum-Keurhorst M, Mangiaracina F, Bergsma A, Vrauwdeunt G, Graff M, Droes RM. User-participatory development of FindMyApps; a tool to help people with mild dementia find supportive apps for self-management and meaningful activities. Digit Health. 2019 Mar 26;5:2055207618822942. doi: 10.1177/2055207618822942. eCollection 2019 Jan-Dec.

    PMID: 30944726BACKGROUND
  • Kerkhof YJ, Graff MJ, Bergsma A, de Vocht HH, Droes RM. Better self-management and meaningful activities thanks to tablets? Development of a person-centered program to support people with mild dementia and their carers through use of hand-held touch screen devices. Int Psychogeriatr. 2016 Nov;28(11):1917-1929. doi: 10.1017/S1041610216001071. Epub 2016 Jul 18.

    PMID: 27425002BACKGROUND
  • Kerkhof Y, Bergsma A, Graff M, Droes RM. Selecting apps for people with mild dementia: Identifying user requirements for apps enabling meaningful activities and self-management. J Rehabil Assist Technol Eng. 2017 Jun 2;4:2055668317710593. doi: 10.1177/2055668317710593. eCollection 2017 Jan-Dec.

    PMID: 31186930BACKGROUND

Related Links

MeSH Terms

Conditions

Dementia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Yvonne Kerkhof, MSc

    Saxion University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 19, 2019

Study Start

October 31, 2017

Primary Completion

December 12, 2017

Study Completion

March 22, 2018

Last Updated

July 19, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations