Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04443621 |
| Other study ID # |
NU20-07-00100 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
September 2020 |
| Source |
Palacky University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Dignity is an integral part of quality of life (QoL). Older adults often face with situations
that are related with the development of dementia and that might significantly affect their
feeling of personal dignity. The aim of the project is to investigate the changes in the
perception of personal dignity amongst older adults with dementia (OAwD) over the course of
three years and to define factors that threaten their dignity. A mixed methods design
(longitudinal prospective study) will be used. In the quantitative part, a battery of Czech
questionnaires will be used, and a translation and validation of a Czech version of the
ACE-III will be carried out. The qualitative part will include in-depth interviews (narrative
and semi-structured). The sample will comprise of OAwD living in home setting. Knowledge of
the changes in the perception of personal dignity and related factors may aid the healthcare
staff in choosing interventions that support and preserve dignity of OAwD as a significant
part of their QoL. The project is a follow-up of a previous project No. 16-28628A.
Description:
A. Introduction to project, current state of art As the population ages, an increasing number
of people will be diagnosed with dementia. At present, there are some 47 million people
living with dementia worldwide. In Czech Republic, there are about 156,000 people suffering
from dementia. Regional estimates of dementia prevalence in people aged 60 years and over now
range from 4.6% in Central Europe to 8.7% in North Africa and the Middle East. It is
estimated up to 131 million people with dementia will live in the world by 2050. Thus, there
is a need of sensitive and specific cognitive assessment tools to detect cognitive
impairment. It enables to provide timely intervention to delay the disease progression,
prolong independence, and enhance the quality of life (QoL) and personal dignity of the
individual with dementia.
Dementia is neurodegenerative disease characterized by progressive, irreversible and still
incurable cognitive decline. People suffering from dementia retain their positive personality
traits and character. However, as the illness progresses, symptoms such as memory loss,
speech impairment, disorientation, difficulties with activities of daily living, and
self-neglect are common. This leads to a significant interference with everyday social and
work activities and has a negative impact on subjective perception of dignity. At present,
the Mini Mental State Examination (MMSE) is used in the Czech Republic to diagnose dementia.
Due to copyright issues with the MMSE (similar to the Montreal Cognitive Assessment [MoCA]
questionnaire), there is a need for another valid tool to be free available in the country.
Currently, the most frequently used tool in the world is the Addenbrooke's Cognitive
Examination III (ACE-III), which is composed of five domains: orientation and attention;
memory; fluency; language, and visuospatial function. The ACE-III-J is a sensitive and
specific screening test to diagnose dementia, and it was better than the MMSE in accuracy for
identifying dementia.
Dignity is described as an integral part of QoL. Similarly to QoL, dignity can also be
understood as a multidimensional concept including: dignity of identity
(self-worth/worthiness, integrity, trust); dignity as a human right (equality, freedom of
choice); and dignity as expression of autonomy (independence, control. There are three main
dimensions essential for constituting dignity: A historical dignity-dimension, acknowledging
one's own life projects and history; an intrapersonal dignity-dimension, recognizing one's
own human worth, and living according to individual values; and an interpersonal
dignity-dimension, experiencing being part of a caring and confirming society.
Jacobson (2007) says that dignity exists in two complementary, yet disparate forms. It is
understood as a dualistic concept incorporating absolute and relative dignity, objective and
subjective dignity, and personal and social dignity. Personal dignity is a type of dignity
that is subjectively perceived by an individual and is linked to a sense of worthiness.
However, personal dignity is also contingent and contextual, and can be influenced both by an
internal aspect, which is the worth and self-respect one ascribes to oneself, as well as by
an external aspect, which is the worth and value ascribed to the individual by others.
Patients with a severe chronic disease (such as neurodegenerative) experience existential
concerns related to changes in the self because of the disease, as well as the social
consequences of the disease (e.g. embarrassment, role changes, loss of independence, and
stigmatization), which can severely affect the sense of personal dignity.
Older adults with dementia (OAwD) are often experiencing an ongoing loss of personal dignity,
value and security, and experiencing cognitive decline can be a threat towards self-respect
and the sense of dignity. The key element of the dementia experience is the effort to
preserve one's identity or sense of self and to preserve a meaningful life. Multiple personal
losses and changes such as increased dependency, loss of autonomy and gradual loss of
abilities or competencies can have a negative impact on the sense of self and the self-esteem
of dementia sufferers. Thus, OAwD are in risk of personal dignity loss due to both impact of
the disease on their identity and self-esteem, and indirectly through negative social
interactions and experiences. Before entering the stage of severe dementia individuals are
aware of the progressive decline in their abilities and actively try to cope with this
decline. A sound sense of personal dignity is essential to the individual's overall
experience of well-being and his/her QoL. Investigation of the factors that maintain and
strengthen personal dignity needs to incorporate data collected from those afflicted.
However, research how having dementia may impact personal dignity into person's subjective
experience of mild to moderate dementia is only very recent.
Pilot data The proposed grant project builds on results of a previous project Trajectories of
quality of life by the elderly in in early-stage dementia (No. 16-28628A). The findings of
the project confirm that OAwD assess their QoL better when they have a greater sense of
personal dignity. The validated Czech version of Patient Dignity Inventory (PDI-CZ) created
and tested in our project No. 16-28628A will be used in the proposed project.
B. Project objectives, project timeline and description of methods and approaches To define
the factors that pose a threat to personal dignity gives an opportunity for a deeper
understanding of these issues. This can subsequently assist healthcare staff with choosing
the optimum interventions supporting QoL amongst OAwD. The proposed project responds to a
society-wide need to identify and solve psychosocial needs of an ageing population with
emphasis on neurodegenerative diseases.
The objective of the project is to investigate the changes in the perception of personal
dignity of OAwD. The opportunity to define risk factors threatening personal dignity over the
course of dementia will contribute to a deeper understanding of patients' needs. This will
help healthcare workers choose the optimum psychosocial interventions in accordance with
Evidence Based Practice and thus protect dignity of OAwD as a major component of QoL. This
may have a positive effect on the psycho-social dimension of QoL amongst OAwD and may lower
the frequency and length of hospitalizations as well as save costs on healthcare and social
services.
The main aim is to ascertain how the subjective perception of personal dignity in OAwD
changes throughout the course of this disease (trajectory of personal dignity perception) and
which factors affect it. Because different types of dementia might have different perceptions
of personal dignity related to specific disturbances of cognitive domains, post-hoc subgroup
analysis in different forms of dementia will be performed. For the assessment of cognition
and diagnosis of dementia, the Addenbrooke's Cognitive Examination III (ACE-III), POBAV, and
ALBA questionnaires will be used. For this reason, we need to create and validate a Czech
version of the ACE-III as the first stage of the project.
In order to achieve the main aim, five sub-aims were identified which should make it possible
to ascertain subjective perception of personal dignity and factors which affect in amongst
OAwD:
1. to create a Czech version of the ACE-III and to conduct a psychometric validation;
2. to ascertain how the assessment of personal dignity changes over the course of 2 years;
3. to identify sociodemographic and clinical factors perceived as a threat to dignity;
4. post-hoc subgroup analysis of results among the different types of dementia;
5. to define the differences in the perception of personal dignity among OAwD when using
quantitative (PDI-CZ) and qualitative (in-depth interview) methods.
C. Methodology In order to reach the set aims, a mixed methods research design (quantitative
survey first follow by qualitative interview) will be used to carry out a longitudinal,
prospective study.
In the quantitative phase of the project using a battery of standardized questionnaires (3
stages). Research nurse gave QAwD the questionnaires and explained how to complete them. The
questionnaires will be completed on project enrolment and then two more times at a 12-month
interval.
In the qualitative phase of the research, individual in-depth interviews with OAwD on the
topic of dignity (two interviews with each respondent at a 12-month interval) will be
conducted, recorded, and transcribed with a subsequent interpretative phenomenological
analysis. Two psychologists will be undertaking the interviews, in order to ensure that the
interviews are conducted in the most sensitive manner. Informed consent will be secured
before each interview. This will be carried out throughout project lifetime.
Questionnaire battery will be included: Addenbrooke's Cognitive Examination III (ACE-III),
Amnesia Light and Brief Assessment (ALBA), POBAV, Patient Dignity Inventory (PDI-CZ), Bristol
Activities of Daily Living Scale (BADLS-CZ), Geriatric Depression Scale (GDS), and a batch of
socio-demographic and clinical characteristics (including age, sex, level of education,
living arrangement, social life, frequency of social visits, telephone contact with
relatives/friends, and the daytime spent alone, illnesses, medication, etc).
Sample The sample will consist of community-dwelling (i.e., living at home) older adults.
They will be addressed together with their family caregivers in neurologic and geriatric
outpatient offices.
Sample size:
First sample (quantitative research) will comprise of 500 respondents (310 OAwD for the
longitudinal, three-stage study and 190 older adults for the validation study ACE-III).
Second sample (qualitative research) - after evaluating the 1st stage of the quantitative
research, we will select 10 OAwD from the sample group with high level (average scale more
than 3) and 10 OAwD who have low level of dignity to understand the different perspectives of
perception of personal dignity. The exact number of respondents will depend on the thematic
saturation in the course of interviewing.
Data from the quantitative research (validation study, and longitudinal study) will be
gathered using a questionnaire from 310 OAwD (longitudinal study) and 190 older adults (half
with dementia and half without dementia; validation study ACE-III) in neurologic and
geriatric outpatients' departments in four regions of the Czech Republic. All data will be
inserted into CASTOR database, from which they will be exported for statistical processing.
Data from the qualitative phase will be gathered using in-depth interviews with 20 OAwD.
These respondents we will select after evaluation the 1st stage of the quantitative research
(10 OAwD with high and 10 OAwD with low levels of dignity to understand the different
perspectives in perception of personal dignity). An interpretative phenomenological analysis
(IPA) will be applied. The IPA is an approach of a qualitative research, which is used to
examine how people make sense of their major life experiences. The method is often used to
study patients' lived experience. The data will be coded in NVivo 12 software for analysis.
To assure reliability of the analysis, two researchers will code the interviews independently
and they will confront their results for similarities and differences.
