Learning and Coping With Dementia - User Experiences From an Educative Intervention in Early Stage Dementia
Phase: NA
Conditions: Dementia, Alzheimer Disease, Vascular Dementia
Sponsor: Helse Stavanger HF

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PROTOCOL 
 
 
 
 
 
Health promotion and quality of life in dementia – User 
experiences from an educative intervention in early 
stage dementia 
 
 
 
Protocol: Version 4 
10/05/2017 
 
 
 
 
Investigators 
Dr Ingelin Testad, RN, PhD 
Centre for Age-Related Medicine (SESAM) 
Stavanger university hospital 
Gerd-Ragna Bloch Thorsensgate 8, 4011 Stavanger, Norway 
 
Martine Kajander, RN, Msc 
Centre for Age-Related Medicine (SESAM) 
Stavanger university hospital 
Gerd-Ragna Bloch Thorsensgate 8, 4011 Stavanger, Norway 
 
 
 
 
 
 
 
 
 
 

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STUDY SUMMARY 
 
 
 
 
TITLE  
Learning and Coping With Dementia - User Experiences From an Educative Intervention in 
Early Stage Dementia 
 
DESIGN  
A quasi-experimental study with multiple methods 
 
AIMS  
The overall aim 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 
 
TARGET POPULATION  
Home dwelling persons with early-stage dementia 
 
SAMPLE SIZE  
100 people over the age of 65  
 
STUDY START 
March 3, 2014 
 
STUDY COMPLETION 
December 31, 2021 [Anticipated] 
 
ETHICAL APPROVAL 
2013/2266 
Regional Committees for Medical and Health Research Ethics, Norway  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Introduction 
There are more than 35 million people living with dementia around the world and these 
numbers are expected to nearly double every 20 years (Prince et al., 2013). Dementia is the 
leading chronic condition among older adults. In Norway there are few services available for 
older adults in early or moderate stages of dementia, and there are few evaluated treatment 
protocols. The Norwegian government´s national Dementia plan 2020: a more dementia 
friendly society (2015) emphasizes the need for educational programmes for people with 
dementia and meeting places for people with dementia for mutual support and the exchange 
of experiences. There is a growing emphasis on providing information and support for people 
diagnosed with dementia. Information and support provided after a diagnosis of dementia may 
lead to health behavior changes that prevent excess disability or premature loss of function 
and institutionalization (Bossen, Specht, McKenzie, 2009; Buettner & Fitzsimmons, 2009). 
 
Dementia is a brain organic syndrome, usually chronic and progressive and defined as 
cognitive impairment of sufficient severity to impair daily functioning, deterioration in 
emotional control, and social behaviour (Engedal & Haugen, 2008). The most common forms 
of dementia are Alzheimer's disease and vascular dementia (Engedal & Haugen, 2008). There 
is currently no treatment that can cure the disease, medications can temporarily slow the 
worsening of symptoms. However, people with dementia are still able to learn new things and 
benefits from challenging their brain, which can help preserving cognitive skills (Martin et al., 
2015; Laakkonen et al., 2016). 
 
Much of the literature on early stage dementia is focused on the caregiver’s perspective, while 
little is known about the perspective of the person with dementia such as the process of 
learning to live with the chronic condition (Testad et al., 2016). In a review by Quinn et al. 
(2016), 15 studies focused on group-based psychosocial interventions developed for people 
with dementia and people with mild cognitive impairment were included. The studies were 
published between 1995 and 2013, and several had methodological limitations, such as few 
participants and lack of robust design. 12 of the studies included interventions for people with 
dementia, while 3 were for people with mild cognitive impairment. Out of the 12 studies there 
were only 3 who had a psychoeducative perspective and 2 who used a self-management 
program. The remaining 7 studies covered support groups and did not have a structured 
educative programme (Quinn et al., 2016). There is a clear need for more research in this area 
and knowledge on whether a structured educative intervention can help people with early-
stage dementia better cope with their disease. Increased knowledge about learning and coping 
with early-stage dementia will be useful in delivering future services. 
 
 
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 behavior. 
 
 
Methods and design 
The design of the study is quasi-experimental with multiple methods: 

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a) 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. 
b) 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. 
c) 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. 
 
The inclusion criteria were as follows: 
• 
65 years of age or older 
• 
Home dwelling 
• 
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. 
 
Recruitment 
Posters advertising the project will be distributed in doctor’s offices and local newspapers 
inviting persons with dementia, family members and/or health care professionals to contact 
the researchers if they were or knew anyone interested in taking part in the study. Participants 
will also be recruited from memory clinics. To ensure participants voluntarily attending the 
study, health care professionals will only hand over eligible participants contact information 
and a research nurse will contacted the participant to go through the inclusion criteria and 
invite them to the study.  
 
Description of the intervention 
An innovative college course for individuals with a newly diagnosed dementia called Health 
Promotion for the Mind, Body, and Spirit has been designed to provide information on the 
disease process and on healthy behaviours to prevent problems that are common later in the 
disease (Fitzsimmons & Buettner, 2009).  
 
The 12-week course includes nutrition, cognitive fitness, stress reduction, communication, 
information about the course of the disease, and coping strategies (Fitzsimmons & Buettner, 
2009). Based on this a Norwegian version of the Health Promotion for the Mind, Body, and 
Spirit called “Dementia school” (Demensskolen) has been developed by this research group 
and tested in a small group of participants. 

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Structure of the course: 
To provide consistency and familiarity, the lead instructors of the course will teach the 
modules, and be present during all classes. The teachers will be retired nurses with great 
experience in education and guidance of people in need for health services. The course will be 
offered in nice surroundings once a week from 10:00 AM to 12:00 noon, for 12 weeks. 
During the first class session participants are provided with name tags and a booklet with the 
course material. 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 session. 
Teaching methods include lecture, question and answer periods, and interactive hands-on 
learning. 
 
Measures 
 
Demographics: 
Standard demographic information will be collected, including age, gender, marital status, 
education, ethnicity, number of hospitalization and nursing home placement. 
 
Cognitive function: 
The Clinical Dementia Rating (CDR) scale (Morris, 1993).The CDR is a validated scale used 
to quantify the severity of symptoms of dementia. Using a structured-interview, six domains 
are assessed in terms of person’s cognitive and functional performance. These include 
memory, orientation, judgment & problem solving, community affairs, home & hobbies, and 
personal care. CDR ratings are 0 for healthy people, 0.5 for questionable dementia and 1, 2 
and 3 for mild, moderate and severe dementia. Scores in each of these are combined to obtain 
a composite score ranging from 0 (none) through 3 (severe). 
 
The Mini Mental State Examination (MMSE) (Folstein, Folstein, & McHuch, 1975).The 
MMSE is a widely used method for assessing cognitive mental status. As a clinical tool, it has 
been used to detect impairment, follow the course of an illness, and monitor response to 
treatment. The MMSE represents a brief, standardized method by which to grade cognitive 
mental status. It assesses orientation, attention, immediate and short-term recall, language, 
and the ability to follow simple verbal and written commands. Additionally, it provides a total 
score that places the individual on a scale of cognitive function. 
 
Mental health status: 
The Neuro Psychiatric Inventory (NPI) (Cummings, et al., 1994) is a validated structured 
interview assessment with the informant (care staff), that assesses behavioural disturbances in 
patients with dementia. This 12-item version consists of 10 behavioural and two 
neurovegetative areas. It provides both a total score as well as scores for a number of sub- 
scales (e.g., delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, 
disinhibition, elation/euphoria, apathy/indifference, irritability/lability, aberrant motor 
activity, sleep, and appetite/eating disorders). The frequency, severity and caregiver distress 
for each domain are measured. The total possible maximum score is 144. A higher score 
reflects increased frequency and severity of the disturbances. This specific version is 
developed for use in nursing homes (NPI-NH), with adapted questions in the standardized 
interview and the caregiver distress assessment is adapted to occupational disruptiveness. 
 

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Cornell Scale for Depression in Dementia (CSDD) (Alexopoulos et al., 1988). The CSDD is 
an assessment of signs and symptoms of major depression in patients with dementia. The 
CSDD uses a comprehensive interviewing approach that derives information via semi-
structured interviews with the participant and the care staff. In this study, relatives will be 
asked instead of care staff. Many of the items during the patient interview can be filled after 
direct observation of the patient. The final ratings of the CSDD items represent the rater's 
clinical impression rather than the responses of the informant or the patient. Each item is rated 
for severity on a scale of 0-2 (0=absent, 1=mild or intermittent,2=severe). The item scores are 
added. Scores above 10 indicate a probable major depression. Scores above 18 indicate a 
definite major depression. Scores below 6 as a rule are associated with absence of significant 
depressive symptoms. 
 
Health and functional status: 
The levels of personal an instrumental functioning was measured by Lawton and Brody’s 
Physical Self-Maintenance Scale (P-ADL) and Instrumental Activities of Daily Living Scale 
(I-ADL) (Lawton et al, 1988). The P-ADL sum-score is based on six items (range 0-30) and 
the I-ADL is based on eight items (range 0-31), with higher scores indicating a lower 
function. 
 
Relative Stress Scale: 
The Relative Stress Scale (RSS), developed by Greene (Greene et al., 1982) 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 (Ulstein et al.,2007). 
 
Administration of assessment tools: 
The diagnostic instruments, psychosocial functioning tests and health behaviour questionnaire 
will be administered at baseline and 3 months.  
 
 
Individual interviews: 
To identify promoting and hindering factors of the intervention qualitative data will be 
collected through semi-structured individual interviews with both participants and their 
caregiver (proxy). 5-8 groups consisting of up to 6 participants will be chosen for qualitative 
interviews after the 12-week course. The caregivers role is to contributed with additional 
information as they were the ones observing the person on a daily basis during the 12-weeks. 
There will be used an interview guide with open-ended questions. The questions were 
designed to encourage the participants and their caregiver to express their experiences after 
participating at the 12-week course. The interviews will be recorded by handwritten notes 
which later will be transcribed into reflective, reconstructed field notes.  
 
 
Observational study: 
To study the educational situations, we observe 2-5 groups consisting of up to 6 participants 
over the duration of the course (12-weeks). Data will be collected through moderate 
participant observations (Dewalt & DeWalt, 2011). combined with individual interviews. 
Participants and their caregiver will interviewed prior to attending the 12-week course, over 
the duration of the course a moderate participant observation will be carried out, and shortly 
after the 12-week course individual semi-structured interviews will be arranged with both the 

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participant and their caregiver. The caregivers role is to contributed with additional 
information and support as they were the ones observing the person on a daily basis during 
the 12-weeks. 
 
After each session, the observer discusses the day’s session with the course leaders to clarify 
and validate the observers understanding of the interaction between group participants, the 
peer discussion/ peer support and the participant’s progress. The observations will be recorded 
through handwritten field notes and transcribed immediately after each session. 
 
The 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.  
 
 
Relevance and significance 
Dementia is a major challenge to society, and the societal burden will increase markedly due 
to future demographic changes (Alzheimer Europe, 2014; Vossius et al., 2015). Despite these 
large numbers, there is a huge amount we still don´t know about the condition. There is a 
growing emphasis on providing information and support for people diagnosed with dementia. 
Information and support provided after a diagnosis of dementia may lead to health behavior 
changes that prevent excess disability or premature loss of function and institutionalization 
(Bossen, Specht, McKenzie, 2009; Buettner & Fitzsimmons, 2009). Therefore, given the high 
and growing prevalence of dementia and the tremendous costs of dementia care (Vossius et 
al., 2015), efforts to improve quality of life in early and moderate stages for community 
dwelling persons with dementia and thereby potentially set the stage for a possible improved 
course of the disease, and possible prevention of nursing home placement is of tremendous 
importance to persons with dementia, their caregivers and the society.  
 
 
Patient and Public Involvement  
Service users and carers will play an integral role throughout this program of research to 
ensure the work is based on the principles of Patient and Public Involvement (PPI). Active 
involvement of service users can lead to research of greater quality and relevance owing to the 
unique perspective that users can bring to a research project (Brett et al., 2014). Individuals 
will be identified according to their experiences, with a focus on ensuring a broad 
representative PPI approach. These individuals will be involved throughout each stage of the 
study, as participants of the trials expert group. A group of users will be invited to contribute 
to data analysis and interpretation through workshops with a research team. This will ensure 
that the outcomes and deliverables are accessible and relevant to the people with dementia, 
their caregivers and the health care sector in general. A dedicated dissemination plan will be 
developed in conjunction with users to promote the findings. A close collaboration with users 
will ensure that the lay perspective is covered in presentation of the results. This can increase 
the perceived relevance and acceptance of findings and might lead to optimization of 
implementation of research findings. 
 
Data analysis 
Statistical analyses will be performed using the IBM SPSS statistical package, version 24 for 
Windows®. Baseline characteristics will be explored using descriptive statistics. Differences 
between follow-up and baseline will be tested with Wilcoxon Signed Rank test (paired) and t-
test (paired) for to assess the effectiveness of the intervention. 

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The qualitative data from both individual interviews and observations will be explored using 
content analysis. 
 
Ethical aspects 
The study received formal approval from the Committee for Medical and Health Research 
Ethics of Norway (REC no. 2013/2266). All participants will receive written information 
about the study before taking part. At the day of the screening all participants will provide 
written consent after the study procedures has been explained in detail to the participant and 
their caregiver. 
 
Sponsor 
Helse Stavanger HF will act as the sponsor for this study. 
 
Funding 
Norwegian Extra Foundation for Health and Rehabilitation through Nasjonalforeningen for 
folkehelsen are funding this study.  
 
 
 
References 
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