Learning and Coping With Early Stage Dementia

May 13, 2025 updated by: Helse Stavanger HF

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A 12-week health promotion course
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: A 12-week health promotion course
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive function
Time Frame: Baseline, 3 months
Measured by The Mini Mental State Examination (MMSE)
Baseline, 3 months
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.
Baseline, 3 months
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".
Baseline, 3 months
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.
Baseline, 3 months
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.
Baseline, 3 months
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.
Baseline, 3 months
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.
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

The Dam Foundation
Nasjonalforeningen for folkehelsen

Investigators

  • Principal Investigator: Ingelin Testad, PhD, Helse Stavanger

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2014

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 10, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sus2018mk01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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