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Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia (MTD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677284
Recruitment Status : Suspended (Due to the situation of virus Covid-19, recruitment is paused from 7th April.)
First Posted : September 19, 2018
Last Update Posted : May 21, 2020
Sponsor:
Collaborators:
Karolinska Institutet
Dalarna University
Manipal University
National Rehabilitation Center for Persons with Disabilities, Japan
Information provided by (Responsible Party):
Gunnel Janeslätt, Uppsala University

Brief Summary:

Sweden, like most countries, is undergoing population ageing. This is accompanied by an epidemiologic transition of equal importance, leading to a greater number of people than ever before affected by dementia. Dementia affects thinking, memory, behavior and ability to perform everyday activities, including daily time management. Time orientation and daily management has been shown to influence well-being in older people. There is evidence suggesting that time assistive products can have positive effects on the well-being of both primary users and informal care givers, but this is not sufficient to provide evidence-based guidance for effective interventions, nor to develop innovative and effective solutions.

In order to contribute to the development and use of affordable and appropriate innovative assistive products and services for older people with mild or moderate dementia, the purposes of this project are to investigate and model the relationship between the use of time assistive products by older people with dementia, their daily time management and their well-being, and to devise strategies for the acceptance and use of such products by older people with dementia and informal caregivers.

A mixed longitudinal approach will be used to attain the first purpose, while the second purpose will be accomplished by applying a qualitative method. Women and men aged 65 or older diagnosed with early or moderate dementia (n=74), and their significant others will be eligible for inclusion.

Cooperation with researchers in India and Japan will generate a set of core data, which allows for cross-cultural comparisons of factors related to daily time management and well-being. The three-year project started September 2017, the main study in September 2018.

This project can be expected to contribute important knowledge that can advance the effectiveness of cornerstone social policies such as support for ageing in place and healthy and active ageing, and the reduction of social exclusion of older people.


Condition or disease Intervention/treatment Phase
Dementia Other: Time assistive products Other: Information brochure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Assessments at baseline (t1) is done for each person with dementia (PwD) with informed consent. The coding of each PwD is determined by the memory clinic (first two digits in the code, 10 - 70) and consecutive starting with 01 and on.

A stratified randomization will be prepared in advance by the researchers, in closed envelopes, for each memory clinic. When the assessment is done, the occupational therapist opens the top envelope marked with the code of the PwD to find out allocation to intervention or control.

Intervention will be provided by the occupational therapist at the memory clinic or at other out-patient service during three months. The second data collection (t2) will be done by research assistants. After the assessment (t2), the control group will be offered intervention with prescribed time assistive products, followed by a third assessment (t3) after another three months (6 months after baseline).

Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: The assessments at three and six months (for intervention group t2, for control group t2 and t3) will be performed by research assistants to avoid bias from the care providers (occupational therapists giving intervention). It is anticipated that the research assistant will not be informed of what group the PwD was allocated to.
Primary Purpose: Health Services Research
Official Title: Managing Time With Dementia: Effects of Time Assistive Products on Time-processing Ability, Daily Time Management and Well-being in People With Dementia
Actual Study Start Date : September 30, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Intervention group

Information brochure about daily time management, frequent problems, and suggested strategies to manage them.

Time assistive product. Time assistive products for time perception are products making the passage of time visible and understandable, to know for how long to perform an activity or how long to wait until the next activity starts e.g a time log.

Time assistive products for time orientation includes the use of schedules, calendars and other visual aids to promote orientation to the time of the day, week, or year.

Time assistive products for time management would compensate for deficits in time management and focus on self-scheduling skills.

Other: Time assistive products
The decision on the specific time assistive product to be prescribed will be decided based on current knowledge and the personal goal of the PwD.

Other: Information brochure
The information brochure will provide information frequent problems about daily time management and suggest strategies to manage them.

Active Comparator: Control group
Information brochure about daily time management, frequent problems, and suggested strategies to manage them.
Other: Information brochure
The information brochure will provide information frequent problems about daily time management and suggest strategies to manage them.




Primary Outcome Measures :
  1. Change from baseline in Canadian Occupational Performance Measure (COPM) [ Time Frame: 3 months ]
    COPM is used to identify and measure performance and satisfaction with performance of activities that are meaningful and important for the person with dementia to be able to carry out with support of an assistive product. The one - three prioritized activities are rated on a scale ranging from 1 to 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction. COPM was used for persons with Alzheimers disease and can measure change (Clare et al 2010). Change over time in performance and satisfaction with performance on each activity are deemed to be clinically significant when a change of >2 points occurs (Lindqvist et al., 2013).

  2. Change from baseline in Kit for Time-processing ability (KaTid) [ Time Frame: 3 months ]
    KaTid is a standardized and validated instrument. The items, ranging from easy to hard items, in a flip-page format, most items with pictures to make the instrument accessible for people with cognitive and physical disabilities. The instrument operationalizes the concepts of International Classification of Functioning (ICF): Time perception, time orientation and time management. The items in time perception compare the duration of everyday activities. The items measuring time orientation locating today, time concepts, telling time and quantity of time. The items in time management includes questions about what one would have time to do in a set period, when and for how long to do it. The KaTid in original has good psychometric properties (Cronbach's alpha.78 - .86) (Janeslätt, 2012can be used to evaluate interventions (Wennberg et al., 2018). In this study, a short version with 29 items that fit the capacity of people with mild or moderate dementia will be used.


Secondary Outcome Measures :
  1. Change from baseline in Time-Selfrating (Time-S) [ Time Frame: 3 months ]
    Self-rating of daily time management; evaluated in adults with psychiatric and neuropsychiatric disabilities and was found to have acceptable psychometric properties (Janeslätt et al., 2015).

  2. Change from baseline in Time-Proxy [ Time Frame: 3 months ]
    Time-Proxy is a proxi-rating for caregivers rating the daily time management of the person with Dementia. A version for parents rating the daily time management of children with similar questions had acceptable psychometric properties (Cronbach Alpha of 0.79 - 0.86) and was used as primary outcome in an randomized controlled study with positive results (Wennberg et al., 2017).

  3. Change from baseline in World Health Organisation Well-being Index (WHO-5) [ Time Frame: 3 months ]
    WHO-5 will be used to measure well-being (Heun et al., 2001), a five item scale producing a score range of 0-25, with higher scores indicating greater psychological well-being.

  4. Change from baseline in Carers of Older People in Europe (COPE) Index [ Time Frame: 3 months ]
    COPE Index (Balducci et al., 2008), measuring negative impact of care, positive value of care, and quality of support

  5. Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (Quest) [ Time Frame: 3 months ]
    Quest 2.0 is used to evaluate user satisfaction of an assistive product. The questionnaire consists of 12 items. A scale ranging from 1 to 5 is used, where 1 indicates not satisfied at all with the device and 5 very satisfied with the device.

  6. Demographic data [ Time Frame: Baseline ]
    A study specific questionnaire of demographic data including age, gender, caregiving characteristics and circumstances, country, cultural features (e.g., mono/polychronic) etc.) will be collected from the PwD and from the informal caregiver.


Other Outcome Measures:
  1. Mini Mental State Examination (MMSE) [ Time Frame: Baseline ]
    From patient records to know level of Dementia; mild or moderate.

  2. Clinical Dementia Rating Worksheet (CDR) [ Time Frame: Baseline ]
    From patient records to know level of Dementia; mild or moderate.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild or moderate dementia (as determined by MMSE or CDR score)
  • Self-rated difficulties in daily time management or difficulties identified by caregivers.
  • The person with dementia should know of their disease and feel comfortable discussing experiences related it.
  • The persons should be interested in trying out an assistive product as support in everyday activities for a six-month period.
  • For each person with dementia, one informal caregiver involved in providing support to the person with dementia (PwD), will be included.

Exclusion Criteria:

  • Severe Dementia, ≤ 9 MMSE
  • Mental health problems or psychiatric disorders not connected to dementia status,
  • High levels of physical frailty,
  • Inability to communicate verbally

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677284


Locations
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Sweden
Center fro Clinical Research in Dalarna
Falun, Dalarna, Sweden, SE-791 82
Sponsors and Collaborators
Uppsala University
Karolinska Institutet
Dalarna University
Manipal University
National Rehabilitation Center for Persons with Disabilities, Japan
Investigators
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Principal Investigator: Gunnel Janeslätt, PhD Centre for Clinical Research Dalarna, Nissers väg 3, SE-791 82 Falun, Sweden
Publications:

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Responsible Party: Gunnel Janeslätt, PhD, Principal Investigator, Occupational Therapist (reg), Researcher, Uppsala University
ClinicalTrials.gov Identifier: NCT03677284    
Other Study ID Numbers: FORTE 2017-00029
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gunnel Janeslätt, Uppsala University:
Intervention study
Assistive products
Elderly people
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders