Pilot Study Person-centred Tablet Intervention

Randomised Controlled Feasibility Study Into FindMyApps; First Evaluation of a Tablet Intervention to Promote Self-management and Meaningful Activities in People With Mild Dementia

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.

Study Overview

• Status: Completed
• Conditions: Neurological Rehabilitation; Dementia; Mobile Applications; Activities of Daily Living; Computers
• Intervention / Treatment: Behavioral: FMA group; Behavioral: Control group

Detailed Description

Testing the feasibility and mechanism of impact of FindMyApps, a tablet intervention consisting of a selection tool to help persons with dementia find usable apps for self-management and meaningful activities and a training that supports informal carers to employ errorless learning principles to help people with dementia to learn how to use the tablet and the tool.

An exploratory pilot randomized controlled trial was carried out with a mixed-methods design. Twenty persons with mild dementia and carer dyads were randomly assigned to the FindMyApps group (n = 10) that used the FindMyApps training and selection tool, or a control condition that just got a tablet (n = 10). After informal carers had received the training, the dyads in the experimental group started with the three-month intervention. Pre and post-test measurements consisted of questionnaires and post-test semi-structured interviews.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7500 KB
      • Saxion University of applied Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMA group; Receiving the FMA training and tool	Behavioral: FMA group; 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
Placebo Comparator: control group; Receiving a simple tablet training and some websites	Behavioral: Control group; Receiving an introductory tablet training and some links to websites that recommend usable apps for people with dementia in general

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived self-efficacy people with dementia	Measured with the Dutch version of the 10-item General Self-Efficacy Scale (D-GSE scale). Change/ difference between baseline and post-intervention. Responses are structured on a 4-point scale ranging from 1 (not at all true) to 4 (exactly true). A total score ranging between 10 and 40 is obtained by summing the responses on all ten items; a higher score indicates more self-efficacy.	At baseline and post-intervention at 3 months follow up
Perceived autonomy people with dementia	Measured with the 12-item Experienced Autonomy List (EAL). Change/ difference between baseline and post-intervention. Responses are scored on a 5-point Likert scale ranging from 1 (totally disagree) to 5 (totally agree). Responses to negatively worded items are reverse-coded. The scores on all items were summed to get a sum-score. The sum-score ranges between 12 and 60. A higher score indicates more perceived autonomy.	At baseline and post-intervention at 3 months follow up
Quality of life people with dementia	Measured with the Dementia Quality of Life scale (DQoL). Change/ difference between baseline and post-intervention. It consists of 29 items that are focused on five domains: self-esteem, positive affect, negative affect, feelings of belonging, and sense of aesthetics. All items are rated on a 5-point Likert-type scale. Responses on 'sense of aesthetics' relate to enjoyment and range from 1 (not at all) to 5 (a lot). Responses on the four other subscales relate to frequency and range from 1 (never) to 5 (very often). Scores for the subscales are calculated by computing the mean score. In addition, the DQoL contains one global item to assess overall quality of life on a scale from 1 (bad) to 5 (excellent). A higher score on both the subscales and the global item indicates a higher quality of life.	At baseline and post-intervention at 3 months follow up
Positive care experiences informal carers	Measured with the Positive Experience Scale (PES). Change/ difference between baseline and post-intervention. The PES is an 8-item scale. The answer categories were: (1) agree , not agree/not disagree and disagree, whereby not agree/not disagree are took together as (0) disagree. The scores on all items were summed to get a sum-score. The sum-score ranges between 0 and 8, whereby a higher score indicates more positive care experiences.	At baseline and post-intervention at 3 months follow up
Quality of life informal carers	Measured with the EuroQol-5 Dimensions-5 Levels scale (EQ-5D-5L). Change/ difference between baseline and post-intervention. The EQ-5D-5L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Informal caregivers had the following answer options on these dimensions: (1) no problems, (2) slight problems, (3) moderate problems, (4) severe problems or (5) extreme problems. A mean sum-score was calculated on these dimensions which ranges from 1 till 5, whereby a higher score indicates more problems. Besides that, the EQ-5D-5L consists of the EuroQol Vertical Visual Analogue Scale (EQ VAS), which contains of a 20 centimeter vertical scale ranging from 0 till 100. Informal caregivers rated their health on this scale, whereby a higher score indicates a better health.	At baseline and post-intervention at 3 months follow up
Quality of life informal carers	Measured with The Older Persons and Informal Caregivers Survey Minimum DataSet (TOPICS-MDS). Change/ difference between baseline and post-intervention. In the quality of life topic of TOPICS-MDS informal caregivers were asked to rate their current quality of life on a five-level response scale which ranges from 1 (excellent) till 5 (poor). Besides that, informal carers rated their quality of life in comparison with the previous year on a five-level response scale which ranges from to 1 (much better) till 5 (much worse), whereby a lower score indicates a better quality of life. The last question which informal caregivers answered was about their perceived quality of life. Informal carers answered this question by rating their present life on a scale of 0 till 10, whereby a higher score indicates a better life.	At baseline and post-intervention at 3 months follow up

Collaborators and Investigators

• Sponsor: Saxion University of Applied Sciences
• Collaborators: Radboud University Medical Center; Amsterdam UMC, location VUmc; University of Twente
• Investigators: Principal Investigator: Yvonne Kerkhof, MSc, Saxion University of applied Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Information and enrollment site for future study FMA

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): December 12, 2017
• Study Completion (Actual): March 22, 2018

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Self-management; Medical Research Framework; Hand-held touchscreen devices; Meaningful activities
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: FindMyApps

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