Learning and Coping With Early Stage Dementia
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|ClinicalTrials.gov Identifier: NCT03741543|
Recruitment Status : Active, not recruiting
First Posted : November 15, 2018
Last Update Posted : March 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer Disease Vascular Dementia||Other: A 12-week health promotion course||Not Applicable|
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.
|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|
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
- 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.
- Change in cognitive function [ Time Frame: Baseline, 3 months ]Measured by The Mini Mental State Examination (MMSE)
- 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.
- 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".
- 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.
- 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.
- 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.
- 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.
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
|Principal Investigator:||Ingelin Testad, PhD||Helse Stavanger|