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Learning and Coping With Early Stage Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03741543
Recruitment Status : Active, not recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
Norwegian Extra Foundation for Health and Rehabilitation
Nasjonalforeningen for folkehelsen
Information provided by (Responsible Party):
Helse Stavanger HF

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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Vascular Dementia Other: A 12-week health promotion course Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: a 12-week health promotion course
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Learning and Coping With Dementia - User Experiences From an Educative Intervention in Early Stage Dementia
Actual Study Start Date : March 3, 2014
Estimated Primary Completion Date : June 14, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
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 Name: Psychosocial intervention, group based




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741543


Sponsors and Collaborators
Helse Stavanger HF
Norwegian Extra Foundation for Health and Rehabilitation
Nasjonalforeningen for folkehelsen
Investigators
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Principal Investigator: Ingelin Testad, PhD Helse Stavanger
  Study Documents (Full-Text)

Documents provided by Helse Stavanger HF:
Study Protocol  [PDF] May 10, 2017


Publications:
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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT03741543     History of Changes
Other Study ID Numbers: sus2018mk01
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helse Stavanger HF:
health promotion
early-stage dementia
psychosocial

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