Clinical trial NCT03741543: Learning and Coping With Early Stage Dementia
Official title: Learning and Coping With Dementia - User Experiences From an Educative Intervention in Early Stage Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Vascular Dementia
Keywords: health promotion
early-stage dementia
psychosocial
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: The Dam Foundation
name: The National Association for Public Health, Norway
First posted: 2018-11-15
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a 12-week health promotion course
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall aim of this study is to investigate how home dwelling people with early-stage dementia cope with their disease, explored through their participation in a 12-week health promotion course, through 3 sub-studies; 1) The users' experience in gaining information about dementia and meeting others in the same situation, 2) observation of the group interactions and support processes, and 3) investigate the effect of the 12-week health promotion course for people with early stage dementia on their cognitive function, psychosocial function and health behaviour.

Detailed description: In this study, the investigators build on a health promotion intervention originally developed by Buettner and Fitzimmons (2009), called "Health Promotion for the Mind, Body, and Spirit". The Health Promotion intervention consists of 12 weekly 2-hour sessions. Each group has up to 6 participants, and the groups are facilitated by two professional group leaders. The course has been designed to provide information on the disease process and on healthy behaviours to prevent problems that are common later in the disease. The 12-week course includes nutrition, cognitive fitness, stress reduction, communication, information about the course of the disease, and coping strategies. During the first class session, each participant received a nametag and a booklet. This booklet is a critical component of the educational method for the participants. The booklet contains 12 dividers for the 12 modules that the instructor taught during the course. The caregiver is not present at the course, however the participants are encouraged to share the booklet provided at the course with the caregiver between sessions.

Design: a quasi-experimental study with multiple methods:

1. assessment of cognitive function, psychosocial function and health behaviour is collected at baseline (prior to attending the 12-week course) and follow-up interviews are arranged shortly after the 12-week course. For each participant a caregiver also has to take part for proxy interviews.
2. the users' experience of attending the 12-week health promotion course will be collected through qualitative individual interviews with the participants and their caregiver after attending the course.
3. over the duration of the course a moderate participant observation will be carried out to explore changes over the 12-week course, in-session behaviour, social interaction and to capture motivational and empowering aspects of the course.

Eligibility criteria: Inclusion Criteria:

* 65 years of age or older
* A diagnosis of early or moderate stage dementia
* Capable of reading and writing
* Hearing and vision which are sufficiently good to work in a group setting
* Proficient in the language in which the course is provided

Exclusion Criteria:

* A diagnosis of alcohol abuse
* A limited life expectancy due to any terminal disease or other serious illness
* Chemotherapy or radiation treatment ongoing at enrolment
* Head injuries
* Epilepsy
* Parkinson's disease
* A history of psychiatric illness
* A history of a diagnosis of subnormal intelligence
* Prior participation in health promotion or cognitive training programs

Primary outcomes:
measure: The users experiences from an educative intervention in early-stage dementia
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in cognitive function
timeFrame: Baseline, 3 months
measure: Change in depressive symptoms
timeFrame: Baseline, 3 months
measure: Change in self-rated health
timeFrame: Baseline, 3 months
measure: Change in managing personal activities of daily life
timeFrame: Baseline, 3 months
measure: Change in managing instrumental activities of daily life
timeFrame: Baseline, 3 months
measure: Change in neuropsychiatric symptoms
timeFrame: Baseline, 3 months
measure: Change in carer stress/burden
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Helse Stavanger
name: Ingelin Testad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buettner LL, Fitzsimmons S. Promoting health in early-stage dementia: evaluation of a 12-week course. J Gerontol Nurs. 2009 Mar;35(3):39-49. doi: 10.3928/00989134-20090301-02.
citation: Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.
citation: Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
citation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
citation: Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
citation: Testad I, Kajander M, Gjestsen MT, Dalen I. Health promotion intervention for people with early-stage dementia: A quasi-experimental study. Brain Behav. 2020 Dec;10(12):e01888. doi: 10.1002/brb3.1888. Epub 2020 Oct 16.
citation: Kajander, M., Gjestsen, M. T., Vagle, V., Meling, M., Henriksen, A. T., & Testad, I. (2022). Health promotion in early-stage dementia-user experiences from an educative intervention. Educational Gerontology, 48(9), 391-403.
citation: Kajander M, Gjestsen MT, Ballard C, Naess H, Testad I. Health Promotion in Early-Stage Dementia: A Focused Ethnographic Study of a 12-Week Group-Based Educational Intervention. SAGE Open Nurs. 2024 Jul 25;10:23779608241266686. doi: 10.1177/23779608241266686. eCollection 2024 Jan-Dec.
citation: Kajander M, Gjestsen M T, Ballard C, Naess H, Tovar-Rios D A, Fossey J, Testad I. Health promotion in early-stage dementia: Exploring associations between sociodemographic characteristics and outcomes of a 12-week group-based educational intervention. Educational Gerontology. 2024; 1-14. doi: https://doi.org/10.1080/03601277.2024.2358620