Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04988880 |
| Other study ID # |
PR(AG)334/2021 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
July 31, 2024 |
Study information
| Verified date |
October 2022 |
| Source |
Hospital Universitari Vall d'Hebron Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction: Multiple sclerosis (MS) affects about 50,000 people in Spain, so it is
essential to implement health interventions that meet their needs and demands. Expert patient
programs facilitate health-related empowerment through peer learning. From a study of focus
groups that identified the characteristics and contents of an expert patient program for MS
and the ongoing pilot tests, the need for implementation in the different reference units of
Catalonia is established.
Hypothesis: The territorial implementation in Catalonia of a Catalonia® Expert Patient
Program for people with MS (PPEC-EM) based on peer learning will improve the quality of life,
knowledge and self-management related to the health process of the participants.
Objective: To deploy and evaluate the territorial implementation of a PPEC-EM based on peer
learning regarding the quality of life, knowledge and self-management related to the health
process of the participants.
Methodology: Pre-post intervention multicenter clinical study. This study will begin after
the approval of the respective Ethics Committees. The deployment will consist of 12 groups of
patients (2 per unit): 6 groups with people with recurrent MS and 6 groups with people with
progressive MS. A patient with MS previously trained by a team of health professionals will
lead 9 educational group sessions (1 weekly session for 9 weeks) with 12 people with the same
disease in order to improve the impact and self-management according to the health process.
The main variable is the improvement of the quality of life and the secondary ones are the
emotional impact, activation of the person, knowledge on the MS, fatigue, habits and
lifestyles, use of the sanitary services and program-related experience of participants. All
variables will be measured before and after the intervention and after 6 and 12 months. A
pre-post comparability analysis will be developed in relation to the variables studied.
Description:
Scope. The study will be carried out in 6 specialized reference units in Catalonia for the
group of patients diagnosed with MS. All these units are multidisciplinary reference units in
Girona, Barcelona, Tarragona and Lleida for the group of patients diagnosed or suspected of
demyelinating disease and specifically MS.
Design. Pre-post intervention multicenter clinical study to evaluate the territorial
implementation of a specific Multiple Sclerosis Expert Patient Program of Catalonia (PPEC-EM)
based on peer learning regarding quality of life, knowledge and self-management related to
the health process of participants in 6 areas in Catalonia. It will start after the approval
of the respective Ethics Committees. The deployment will consist of 12 groups of patients (2
per unit): 6 groups with people with recurrent MS and 6 with people with progressive MS.
Population. All people with a diagnosis of MS treated in the 6 reference units of Catalonia
for people with MS will be eligible to be recruited to participate in the deployment of the
PPEC-EM.
Recruitment. The diagnosis and follow-up of patients is carried out in the respective units
and involves therapeutic support by the multidisciplinary team in the clinical consultation,
the day care clinic or through a spontaneous consultation. Once a clinical visit has been
made by a healthcare professional, where lack of knowledge regarding MS or the need for
support to perform an effective self-management are detected, patient will be referred to the
centre's study coordinator to explain the study, its purpose and to provide complete
information to the patient. In case of acceptance, the professional will assess whether IC /
EC are met. If so, the study coordinator will ask participants for their informed consent.
Sample size. It is intended to constitute 12 groups of patients (6 for people with remitting
and 6 for progressive MS; one of each type per unit). Based on the methodology used in the
program, the recruitment target will be 12 subjects per group (144 individuals in total).
This is expected to compensate for possible losses during the intervention to ensure a
minimum presence of 8-10 subjects per group throughout the program (96-120 individuals).
Study variables Dependents: quality of life, emotional impact, fatigue, activation of the
person, knowledge of MS, habits and lifestyles, use of health services (number of primary
care visits; number of emergency department visits; number visits unscheduled in the MS
unit), medication, nutrition, exercise and program-related experience of the EP and the
participants.
Independent variables
- Sociodemographic: year of birth (YYYY); sex (woman / man); marital status (single /
married or in a couple); family support (yes / no); level of education (no studies /
basic / Professional Training-Baccalaureate / higher education); employment situation
(student / active / retired - with a disability).
- Of the disease. Baseline. Date of diagnosis (DD / MM / YYYY); type of MS (recurrent /
progressive); EDSS (X.X); family history of MS (yes / no); treatment (with MS treatment
/ no treatment); type of medication (self-administered / hospital-administered); name of
the active ingredient; percentage of medication collected at a pharmacy or drug
administered (XX.XX%).
- Of the disease. Follow-up. treatment (with MS treatment / no treatment); type of
medication (self-administered / hospital-administered); name of the active ingredient;
percentage of medication collected at a pharmacy or drug administered (XX.XX%);
medication change during the program (yes / no); number of new relapses according to
medical history (XX); EDSS (X.X).
- Program variables: Attendance at all program sessions (yes / no); number of sessions
attended (0-9); attendance at session 1 (yes / no); attendance at session 2 (yes / no);
attendance at session 3 (yes / no); attendance at session 4 (yes / no); attendance at
session 5 (yes / no); attendance at session 6 (yes / no); attendance at session 7 (yes /
no); attendance at session 8 (yes / no); attendance at session 9 (yes / no); attendance
at the M6 follow-up session (yes / no); attendance at the M12 follow-up session (yes /
no).
Description of the questionnaires and test
1. Quality of life. Multiple Sclerosis Quality of Live - 54 items (MSQoL-54) (Vickrey,
Hays, Harooni, Myers, & Ellison, 1995) and its Spanish adaptation by Aymerich in 2006
(Aymerich et al., 2006). It is a self-administered questionnaire, filled in
approximately 15 minutes. It consists of 54 items, 36 correspond to the generic SF-36
questionnaire and the remaining 18 are specific to MS. The items are distributed in 12
dimensions and 2 individual items that measure changes in health status (comparison
between current health and previous year) and satisfaction with sexual function. In
addition, two subtotals corresponding to two scales are obtained: mental and physical
health. Therefore, the MSQoL54 questionnaire is a relevant tool for assessing the impact
of the PPEC-EM on participants 'quality of life.
2. Emotional impact. The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith,
1983) and the Catalan version made by Soto in 2018 (Soto, Gras, & Planes, 2008) is a
specific instrument for detecting the level of anxiety or depression of an individual in
the last 7 days. It consists of a self-administered questionnaire of 14 items, 7
corresponding to the anxiety subscale and 7 to the depression subscale. Each of the
items has a rating from 0 to 3 (0 being the minimum affectation and 3 the maximum). A
score from 0 to 7 indicates no disorder, 8 to 10 is a questionable case, and ratings
above 11 clearly indicate the presence of anxiety or depressive disorder respectively.
For all this it is a useful tool to detect those individuals with a condition that would
indicate the need for a referral to a health professional for assessment and care
(exclusion criteria) and to evaluate the effectiveness of the program on MS-related
emotional impact.
3. Cognitive impairment. The Brief International Cognitive Assessment for Multiple
Sclerosis (BICAMS) battery was proposed in 2012 (Langdon et al., 2012) as a cognitive
election screening tool in MS it is used widely internationally. It was translated into
Spanish (Vanotti, Smerbeck, Benedict, & Caceres, 2016) and there are scales to determine
whether a patient with MS has significant cognitive impairment. As described in the
literature, if a patient has a score of -1.5 SD of the population mean in one of the 3
subtests administered, cognitive impairment is estimated. Patients who exceed this point
will be excluded from the study.
4. Fatigue. The Fatigue Severity Scale (FSS) (Krupp, LaRocca, Muir-Nash, & Steinberg, 1989)
and its Spanish translation by Tola in 1998 (Tola, Yugueros, Fernández-Buey, &
Fernández-Herranz, 1998) is an instrument that assesses the impact of fatigue on a
person's daily life. It consists of a self-administered questionnaire of 9 items, each
with a rating from 1 to 7 (with 1 strongly disagreeing and 7 strongly disagreeing).
Therefore, it will be possible to evaluate the impact of the program on the management
of the fatigue of the participants.
5. Patient activation (engagement). The 13-item Patient Activation Measure (PAM-13) and its
validation in Spanish by Moreno-Chico in 2017 (Moreno-Chico et al., 2017) is an
instrument that assesses knowledge, skills and people's confidence in self-management of
their health and medical care. It consists of a self-administered questionnaire of 13
items, each with a rating from 1 to 4 (with 1 strongly disagreeing and 4 strongly
disagreeing). Therefore, it allows us to evaluate the impact of the program on the
activation and involvement of the participants.
6. Knowledge of MS. The panel of experts of the PPEC developed a specific questionnaire
about the knowledge of MS that includes information related to the disease and specific
aspects identified by the target population through a study of focus groups
(Robles-Sanchez et al., 2020) identified as essential to empower themselves regarding
the health condition. This questionnaire will assess the impact of the program on the
knowledge acquired.
7. Habits and lifestyles. The PPEC coordinating panel developed a specific questionnaire to
assess habits and lifestyles, this questionnaire has already been used in other variants
of the program demonstrating its usefulness in assessing changes due to participation in
this program.
8. Socio-demographic and disease variables. The PPEC coordinating panel developed a
specific questionnaire for each of these variables specifically for this study.
9. Patient Reported Experience. The panel of experts of the PPEC developed a specific
questionnaire about the Patient Reported Experience that includes information related to
the experience lived by individuals regarding the programme. This questionnaire will
assess the experience of individuals regarding the intervention.
Data collection. All variables will be measured pre and post intervention and at 6 and 12
months, so a session will be held in these periods to collect the questionnaires and offer
the possibility of clarifying concepts or doubts that may arise regarding the contents of
previous sessions. Participants will receive the questionnaires to be filled in at their home
by means of the corporate email of the program and these will be returned by the participants
by e-mail. At 12 months after the study, the original questionnaires will be collected
through a courier service by the PPEC-EM.
Intervention. The study will be conducted virtually due to the current pandemic situation
(SARS-CoV-2). For this reason, Teams virtual platform will be used, provided by PPEC managers
linked to the Generalitat de Catalunya and for use endorsed by the aforementioned
institution. The aim of the intervention is to reinforce positive knowledge in a concise,
clear way and with language that can be understood by the participants. (See intervention
description for further information).
Analysis of results. Continuous variables will be described with mean and standard deviation
(SD) or median and interquartile range (RIQ) in case of non-compliance with normality
criteria and categorical variables with absolute frequency and percentages. The
non-parametric U Mann-Whitney test for independent samples and the Wilcoxon test for
dependent samples will be used to analyze the relationship between a category variable and a
numerical variable. The Chi2 test or the Fisher's exact test will be used to analyze the
relationship between two category variables. A significance level of 5% will be considered.
The data will be analyzed using the SPSS statistical program with the latest version
available.
Ethical aspects. The study protocol will be presented to the CEICs of the respective units.
The foundations of the Declaration of Helsinki will be respected as well as the current
legislation on confidentiality of personal data and the ethical norms on clinical studies,
guaranteeing the strict fulfillment of the Law of protection of personal data, in Spain,
Organic Law 3/2018, of 5 December, on the Protection of Personal Data and the guarantee of
digital rights (BOE 6 December 2018, applicable from 7 December 2018). Participants will not
be compensated for their inclusion or follow-up and will be informed of the voluntary nature
of their participation, guaranteeing the confidentiality of data. All data collected will be
incorporated into a computerized database, where participants will be identified with a code.
No data will be shared. Each center will send the results to the HUVH coordinating center,
the IP will guard the database. The database will be saved until the analysis is complete.
