Pilot Study Person-centred Tablet Intervention
Primary Purpose
Dementia, Mobile Applications, Computers
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
FMA group
Control group
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Medical Research Framework, Hand-held touchscreen devices, Self-management, Meaningful activities
Eligibility Criteria
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.
Sites / Locations
- Saxion University of applied Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FMA group
control group
Arm Description
Receiving the FMA training and tool
Receiving a simple tablet training and some websites
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04026061
First Posted
July 9, 2019
Last Updated
July 18, 2019
Sponsor
Saxion University of Applied Sciences
Collaborators
University of Twente, Radboud University Medical Center, Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT04026061
Brief Title
Pilot Study Person-centred Tablet Intervention
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
March 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saxion University of Applied Sciences
Collaborators
University of Twente, Radboud University Medical Center, Amsterdam UMC, location VUmc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Mobile Applications, Computers, Neurological Rehabilitation, Activities of Daily Living
Keywords
Medical Research Framework, Hand-held touchscreen devices, Self-management, Meaningful activities
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMA group
Arm Type
Experimental
Arm Description
Receiving the FMA training and tool
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Receiving a simple tablet training and some websites
Intervention Type
Behavioral
Intervention Name(s)
FMA group
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Receiving an introductory tablet training and some links to websites that recommend usable apps for people with dementia in general
Primary Outcome Measure Information:
Title
Self-management abilities people with dementia
Description
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.
Time Frame
At baseline and post-intervention at 3 months follow up
Title
Participation in daily and social activities people with dementia
Description
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.
Time Frame
At baseline and post-intervention at 3 months follow up
Title
Participation in daily and social activities people with dementia
Description
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.
Time Frame
At baseline and post-intervention at 3 months follow up
Title
Feeling of competence informal carers
Description
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.
Time Frame
At baseline and post-intervention at 3 months follow up
Secondary Outcome Measure Information:
Title
Perceived self-efficacy people with dementia
Description
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.
Time Frame
At baseline and post-intervention at 3 months follow up
Title
Perceived autonomy people with dementia
Description
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.
Time Frame
At baseline and post-intervention at 3 months follow up
Title
Quality of life people with dementia
Description
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.
Time Frame
At baseline and post-intervention at 3 months follow up
Title
Positive care experiences informal carers
Description
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.
Time Frame
At baseline and post-intervention at 3 months follow up
Title
Quality of life informal carers
Description
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.
Time Frame
At baseline and post-intervention at 3 months follow up
Title
Quality of life informal carers
Description
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.
Time Frame
At baseline and post-intervention at 3 months follow up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Kerkhof, MSc
Organizational Affiliation
Saxion University of Applied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saxion University of applied Sciences
City
Enschede
State/Province
Overijssel
ZIP/Postal Code
7500 KB
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30944726
Citation
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.
Results Reference
background
PubMed Identifier
27425002
Citation
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.
Results Reference
background
PubMed Identifier
31186930
Citation
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.
Results Reference
background
Links:
URL
http://findmyapps.onderzoek.io/
Description
Information and enrollment site for future study FMA
Learn more about this trial
Pilot Study Person-centred Tablet Intervention
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