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Completed

NCT Number: NCT03741543

Learning and Coping With Early Stage Dementia

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.

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Key information

Conditions

Dementia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Vascular Dementia Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A 12-week health promotion course

Other

The Health Promotion intervention consists of 12 weekly 2-hour sessions with a group of up to six participants and two course facilitators. Teaching methods includes lecture, questions- and answer periods, and interactive hands-on learning. During the class sessions, the facilitators encourages the participants to ask questions and make comments about the lecture at any time. During the first class session, each participant receives a booklet with the course material.

Other names: Psychosocial intervention, group based

Primary outcomes

  1. The users experiences from an educative intervention in early-stage dementia

    Time frame: Baseline, 3 months

    Qualitative data will be collected through semi-structured individual interviews with both participants and their caregiver (proxy), and through moderate participant observations following the participants over the duration of the 12-week course. The interview guide and observational protocol consist of pre-selected topics, including (1) communication, (2) participant engagement, (3) social interaction within the group, (4) peer support (5) change in perception of living with dementia and (6) educational outcome. The qualitative data will be explored using content analysis.

Secondary outcomes

  1. Change in cognitive function

    Time frame: Baseline, 3 months

    Measured by The Mini Mental State Examination (MMSE)

  2. Change in depressive symptoms

    Time frame: Baseline, 3 months

    Depressive symptoms will be measured by the Cornell Scale for Depression in Dementia (CSDD) (Alexopoulos et al., 1988).The CSDD is an assessment of signs and symptoms of depression in people with dementia. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). Sum score above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 are associated with absence of significant depressive symptoms.

  3. Change in self-rated health

    Time frame: Baseline, 3 months

    Self-rated health will be measured by The EuroQol visual analogue scale (VAS) (The EuroQol group, 1990). The EQ VAS measures the participants self-rated Health-Related Quality of Life on a vertical, visual analogue scale, form 0-100. Where 0 presents "worst imaginable health state" and 100 represents "best-imagined health state".

  4. Change in managing personal activities of daily life

    Time frame: Baseline, 3 months

    The levels of personal functioning in daily life will be measured by Lawton and Brody's Physical Self-Maintenance Scale. The sum-score is based on six items (range 0-30), with higher scores indicating a lower function.

  5. Change in managing instrumental activities of daily life

    Time frame: Baseline, 3 months

    The levels of instrumental functioning in daily life will be measured by Instrumental Activities of Daily Living Scale (I-ADL) (Lawton et al, 1969). The I-ADL sum-score is based on eight items (range 0-31), with higher scores indicating a lower function.

  6. Change in neuropsychiatric symptoms

    Time frame: Baseline, 3 months

    Neuropsychiatric symptoms will be assessed using The Neuropsychiatric Inventory (NPI) (Cummings, et al., 1994), a 12-item questionnaire developed to assess behavioural disturbances in people with dementia. Scores are entered for the frequency and degree of seriousness of each symptom over the last four weeks, and subsequently multiplied into a symptom score. The total possible maximum score is 144. A higher score reflects increased frequency and severity of the disturbances.

  7. Change in carer stress/burden

    Time frame: Baseline, 3 months

    To measure caregiver burden the Relative Stress Scale (RSS), will be used. RSS assesses the caregiver burden for people caring for individuals with dementia. The RSS has 15 different questions, each scored 0-4 (0=never/not at all, 1=rarely/a little, =sometimes/moderately, 3=frequently/quite a lot, 4=always/considerably perceived burden), with a total score range of 0-60. Higher scores reflect a higher reported caregiver burden.

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • The Dam Foundation
  • The National Association for Public Health, Norway

Registry information

Official study title

Learning and Coping With Dementia - User Experiences From an Educative Intervention in Early Stage Dementia

Important dates

Study start
2014
Primary completion
2019
Study completion
2024
First posted
Nov 15, 2018
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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