DementiaNCT04026061
Pilot Study Person-centred Tablet Intervention
A study testing FMA group in people with Dementia and Mobile Applications, run by Saxion University of Applied Sciences at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Mobile Applications, Computers
- What is being tested?
- FMA group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Oct 2017to 22 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participation in another intervention trial
- Severe visual and/or physical impairment.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Saxion University of applied Sciences
Enschede, Overijssel, 7500 KB
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia, Mobile Applications, Computers, Neurological Rehabilitation, Activities of Daily Living
- Being tested
- FMA group, Control group
- Keywords
- Medical Research Framework, Hand-held touchscreen devices, Self-management, Meaningful activities
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMA groupBehavioural
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
Control groupBehavioural
Receiving an introductory tablet training and some links to websites that recommend usable apps for people with dementia in general
| Study group | Role | What they receive |
|---|---|---|
| FMA group | Experimental | Receiving the FMA training and tool Receives: Behavioral: FMA group |
| control group | Placebo comparator | Receiving a simple tablet training and some websites Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and post-intervention at 3 months follow up
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and post-intervention at 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start31 Oct 2017
- Primary completion12 Dec 2017
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saxion University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, Radboud University Medical Center, Amsterdam UMC, location VUmc
- Responsible party
- Sponsor
- Investigators
- Yvonne Kerkhof, MSc, Principal investigator, Saxion University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026061
- Sponsor's protocol ID
- FindMyApps
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30944726Kerkhof 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.
PubMed 27425002Kerkhof 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.
PubMed 31186930
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Feasibility Study Into FindMyApps; First Evaluation of a Tablet Intervention to Promote Self-management and Meaningful Activities in People With Mild Dementia
- ClinicalTrials.gov ID
- NCT04026061
- Acronym / sponsor ID
- FindMyApps
- Conditions
- Dementia, Mobile Applications, Computers, Neurological Rehabilitation, Activities of Daily Living
- Keywords
- Medical Research Framework, Hand-held touchscreen devices, Self-management, Meaningful activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saxion University of Applied SciencesUniversity, hospital or other
- Collaborators
- University of Twente, Radboud University Medical Center, Amsterdam UMC, location VUmc
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMA group | Experimental | Behavioral: FMA groupReceiving the FMA training and tool |
| control group | Placebo comparator | Behavioral: Control groupReceiving a simple tablet training and some websites |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Participation in another intervention trial
- Severe visual and/or physical impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMA groupA 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 | Behavioural | FMA group |
| Control groupReceiving an introductory tablet training and some links to websites that recommend usable apps for people with dementia in general | Behavioural | control group |
Primary outcome
Self-management abilities people with dementia
Time frame: At baseline and post-intervention at 3 months follow up
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.
Participation in daily and social activities people with dementia
Time frame: At baseline and post-intervention at 3 months follow up
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.
Participation in daily and social activities people with dementia
Time frame: At baseline and post-intervention at 3 months follow up
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.
Feeling of competence informal carers
Time frame: At baseline and post-intervention at 3 months follow up
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.
6 secondary outcomes
Perceived self-efficacy people with dementia
Time frame: At baseline and post-intervention at 3 months follow up
Perceived autonomy people with dementia
Time frame: At baseline and post-intervention at 3 months follow up
Quality of life people with dementia
Time frame: At baseline and post-intervention at 3 months follow up
Positive care experiences informal carers
Time frame: At baseline and post-intervention at 3 months follow up
Quality of life informal carers
Time frame: At baseline and post-intervention at 3 months follow up
Quality of life informal carers
Time frame: At baseline and post-intervention at 3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Background: PubMed 30944726Kerkhof 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.
- Background: PubMed 27425002Kerkhof 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.
- Background: PubMed 31186930Kerkhof 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.
- Information and enrollment site for future study FMALink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Kerkhof, MSc principal investigator
Saxion University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMA group in people with Dementia and Mobile Applications, run by Saxion University of Applied Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-management abilities people with dementia (time frame: At baseline and post-intervention at 3 months follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026061, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.