Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia

NCT03677284 | Unknown

• 1 other identifier: FORTE 2017-00029
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Intervention study; Assistive products; Elderly people

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Canadian Occupational Performance Measure (COPM)

  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).

  3 months

• Change from baseline in Kit for Time-processing ability (KaTid)

  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.

  3 months

Secondary Outcomes (6)

• Change from baseline in Time-Selfrating (Time-S)

  3 months

• Change from baseline in Time-Proxy

  3 months

• Change from baseline in World Health Organisation Well-being Index (WHO-5)

  3 months

• Change from baseline in Carers of Older People in Europe (COPE) Index

  3 months

• Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (Quest)

  3 months

Other Outcomes (2)

• Mini Mental State Examination (MMSE)

  Baseline

• Clinical Dementia Rating Worksheet (CDR)

  Baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

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; Other: Information brochure

Control group

ACTIVE COMPARATOR

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

Other: Information brochure

Interventions

Time assistive products OTHER

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.

Intervention group

Information brochure OTHER

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

Control group; Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead
• Karolinska Institutet: collaborator
• Dalarna University: collaborator
• Manipal University: collaborator
• National Rehabilitation Center for Persons with Disabilities, Japan: collaborator

Study Sites (1)

Center fro Clinical Research in Dalarna

Falun, Dalarna County, SE-791 82, Sweden

Location

Related Publications (8)

• Janeslatt G, Lindstedt H, Adolfsson P. Daily time management and influence of environmental factors on use of electronic planning devices in adults with mental disability. Disabil Rehabil Assist Technol. 2015;10(5):371-7. doi: 10.3109/17483107.2014.917124. Epub 2014 May 8.

  PMID: 24805929 BACKGROUND

• Boman IL, Nygard L, Rosenberg L. Users' and professionals' contributions in the process of designing an easy-to-use videophone for people with dementia. Disabil Rehabil Assist Technol. 2014 Mar;9(2):164-72. doi: 10.3109/17483107.2013.769124. Epub 2013 Apr 23.

  PMID: 24512219 BACKGROUND

• Balducci C, Mnich E, McKee KJ, Lamura G, Beckmann A, Krevers B, Wojszel ZB, Nolan M, Prouskas C, Bien B, Oberg B. Negative impact and positive value in caregiving: validation of the COPE index in a six-country sample of carers. Gerontologist. 2008 Jun;48(3):276-86. doi: 10.1093/geront/48.3.276.

  PMID: 18591353 BACKGROUND

• Clare L, Linden DE, Woods RT, Whitaker R, Evans SJ, Parkinson CH, van Paasschen J, Nelis SM, Hoare Z, Yuen KS, Rugg MD. Goal-oriented cognitive rehabilitation for people with early-stage Alzheimer disease: a single-blind randomized controlled trial of clinical efficacy. Am J Geriatr Psychiatry. 2010 Oct;18(10):928-39. doi: 10.1097/JGP.0b013e3181d5792a.

  PMID: 20808145 BACKGROUND

• Lindqvist E, Larsson TJ, Borell L. Experienced usability of assistive technology for cognitive support with respect to user goals. NeuroRehabilitation. 2015;36(1):135-49. doi: 10.3233/NRE-141201.

  PMID: 25547777 BACKGROUND

• Lindqvist E, Nygard L, Borell L. Significant junctures on the way towards becoming a user of assistive technology in Alzheimer's disease. Scand J Occup Ther. 2013 Sep;20(5):386-96. doi: 10.3109/11038128.2013.766761. Epub 2013 Feb 11.

  PMID: 23394183 BACKGROUND

• Wennberg B, Janeslatt G, Kjellberg A, Gustafsson PA. Effectiveness of time-related interventions in children with ADHD aged 9-15 years: a randomized controlled study. Eur Child Adolesc Psychiatry. 2018 Mar;27(3):329-342. doi: 10.1007/s00787-017-1052-5. Epub 2017 Sep 27.

  PMID: 28956183 BACKGROUND

• Arntzen C, Holthe T, Jentoft R. Tracing the successful incorporation of assistive technology into everyday life for younger people with dementia and family carers. Dementia (London). 2016 Jul;15(4):646-62. doi: 10.1177/1471301214532263. Epub 2014 Apr 29.

  PMID: 24784941 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Gunnel Janeslätt, PhD

  Centre for Clinical Research Dalarna, Nissers väg 3, SE-791 82 Falun, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Principal Investigator, Occupational Therapist (reg), Researcher

Model Details: 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).

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: September 19, 2018
• Study Start: September 30, 2018
• Primary Completion: November 15, 2022
• Study Completion: December 31, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)