Oropharyngeal DysphagiaHECGPNNCT05405829
Health Education to Caregivers to Reduce Aspiration Pneumonia
A study testing Health education in people with Oropharyngeal Dysphagia and Pneumonia, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Randomized clinical study with a control group for assessing the decrease in the incidence of pneumonia, in a 12-month follow-up, in older people with cognitive impairment, risk of bronchial aspiration, risk of malnutrition and dependence to perform basic activities of daily living, through the design and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia, Pneumonia, Malnutrition
- What is being tested?
- Health education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2019to 28 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Patient inclusion criteria:
- People over 65 years of age, with cognitive impairment, evaluated with the Pfeiffer Test ≥ 3. With risk of bronchoaspiration, detected by the presence of oropharyngeal dysphagia and confirmed with the test (V-VST). Risk of malnutrition, evaluated with the MNA-SF test ≤ 11 and with dependency to perform the basic activities of daily living, with a Barthel index ≤ 61.
- Voluntary participation and signing the informed consent after being informed orally and in writing about the study, the patient or responsible relative.
Caregiver inclusion criteria:
- Voluntary participation and signing the informed consent after being informed orally and in writing about the study.
Patient exclusion criteria:
- Patients with a high degree of oropharyngeal dysphagia (that is, when they bronchoaspirate when administering 5 ml of pudding texture while performing the test (V-VST) to measure oropharyngeal dysphagia).
- Patients with delirium at the time of evaluation.
- Institutionalized patients, in residences or long stay.
Caregiver exclusion criteria:
- That the caregiver is not the usual one. This means that, at the time of the study, the patient is not cared for by the usual reference person. Therefore, the caregiver is present in a punctual and transitory situation.
- That patients or their caregivers do not understand the Catalan or Spanish language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Educational Intervention for Caregivers of the Elderly With Cognitive Impairment and Risk of Bronchial Aspiration, to Reduce Episodes of Pneumonia. A Randomized Clinical Trial.
Randomized clinical study with a control group for assessing the decrease in the incidence of pneumonia, in a 12-month follow-up, in older people with cognitive impairment, risk of bronchial aspiration, risk of malnutrition and dependence to perform basic activities of daily living, through the design and implementation of an educational program. to the caregivers of these patients.
Read the detailed description
Introduction: The number of people over 65 years of age is increasing, observing an older population worldwide. In the year 2050 there will be 2,000 million, this situation is due to medical and technological advances, in addition to the declining birth rate. People live longer, but there is also a higher incidence of chronic diseases, associated with age. Among them, neurodegenerative diseases stand out, due to the dependence they entail, as well as the risk of situations such as episodes of bronchial aspiration, which can cause pneumonia that will require hospital admissions, as well as the risk of malnutrition and dependence to carry out basic activities of daily life. .
Most of these patients are cared for at home by their caregivers, who, in addition to not knowing how to care for oropharyngeal dysphagia, the situation of prolonged fatigue can generate overload and anxiety for the caregiver.
Objective: To evaluate the decrease in the incidence of pneumonia, in a 12-month follow-up, in older adults with cognitive impairment, risk of bronchial aspiration, risk of malnutrition and dependence to carry out basic activities of daily living, through the design and implementation of a educational program. to the caregivers of these patients.
Methodology: A sequential exploratory mixed study will be carried out. For the design of the educational intervention, a descriptive qualitative study will be carried out with focus groups of caregivers and the recommendations of the Health Literacy model will be followed. To evaluate the efficacy of this intervention, a pre-post intervention randomized clinical trial with a control group will be carried out. The sample will be 178 couples made up of caregivers (formal or informal non-professional caregivers) and people over 65 who are in their care. The study will be carried out at the Parc Sanitari Per Virgili in Barcelona from May 2019 to March 2023. The main variables and study instruments are the incidence and admissions for pneumonia, as well as its delay in onset in older people, measured by Clinical history, cognitive impairment, measured with the Pfeiffer test, the risk of bronchial aspiration measured with the volumetric viscosity exploratory method test (V-VST), the risk of malnutrition measured with the Mini Nutritional Assessment short-form scale (MNA- SF). In addition to the anxiety and overload of their caregivers, measured with the Goldberg and Zarit scale.
- Conditions
- Oropharyngeal Dysphagia, Pneumonia, Malnutrition
- Being tested
- Health education
- Keywords
- Elderly, Swallowing Disorders, pneumonia, caregivers
- Medical subject headings
- Deglutition Disorders, Pneumonia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationOther
theoretical-practical hygienic-dietary training, with visual support and work materials where three specific interventions are explained: textures for solids and liquids, safety postures to reduce the risk of bronchial aspiration, and oral hygiene. In addition, tools are offered to caregivers so that they can identify situations of anxiety and overload, as well as guidelines for social support.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Conventional information received by caregivers. The speech therapist comes to the room to pass the Volume viscosity exploratory method test (V-VST) Test and after confirming dysphagia, informs the patient of the test result and delivers a booklet of recommendations. Receives: Other: Health education |
| Intervention group | Experimental | A 45-minute session, hygienic-dietary training, with visual support and work materials where three specific interventions are explained: textures for solids and liquids, safety postures to reduce the risk of bronchial aspiration, and oral hygiene. In addition, tools are offered to caregivers so that they can identify situations of anxiety and overload, as well as guidelines for social support. Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variable: pneumonia.
Qualitative variable, dichotomous (yes/no). Pneumonia is defined according to the International Classification of Diseases of the lungs (ICD 11), often caused by infection by bacteria, viruses, fungi or parasites, although not always. It is characterized by fever, chills, productive cough, chest pain, and dyspnea" (WHO 2022). Measured through self-prepared questionnaire and Clinical History.
Measured: At 12 months before entering the study; At 3 months before entering the study; At 3 months after entering the study; At 12 months after entering the study
Variable: time of onset of pneumonia.
Discrete quantitative variable. The elapsed time measured in months from the intervention to the appearance of the first pneumonia is considered.
Measured: At 3 months after entering the study; At 12 months after entering the study.
Variable: Admission for pneumonia in the last year.
Qualitative, dichotomous variable (yes/no). Measured through own questionnaire.
Measured: At 3 months after entering the study; At 12 months after entering the study.
Variable: Number of admissions for pneumonia in the last year.
Discrete numerical quantitative variable. Measured through the Clinic History and own questionnaire.
Measured: At 12 months before entering the study; At 3 months before entering the study; At 3 months after entering the study; At 12 months after entering the study
Variable: Malnutrition risk.
Continuous quantitative variable. It is defined as "an unbalanced nutritional state resulting from insufficient nutrient intake to meet normal physiological requirements". Measured with Scale Mini Nutritional Assessment-Short Form (MNA-SF). Through the Clinic History and own questionnaire.
Scale to assess malnutrition (maximum score of 14 points). 12-14 points: normal nutritional status; 8-11 points: risk of malnutrition; 0-7 points: malnutrition.
Measured: At study entry; At 3 months after entering the study; At 12 months after entering the study
Variable: Cognitive impairment.
Discrete quantitative variable. Cognitive impairment is defined according to the Medical Subject Headings (MeSH) descriptor, as "the decrease or deterioration of mental and/or intellectual function". Measured with Pfeiffer test.
Pfeiffer scale, It consists of 10 items. Between 0-2: it is considered normal; Between 3-4: mild cognitive impairment Between 5-7: moderate cognitive impairment; More than 8 errors: severe cognitive impairment.
Measured: At study entry; At 3 months after entering the study; At 12 months after entering the study
Variable: Risk of Bronchoaspiration.
Discrete quantitative variable. It is defined as "A type of pulmonary inflammation resulting from the aspiration of food, liquid, or gastric contents into the upper respiratory tract." Measured with the volume-viscosity swallow test (V-VST).
Test performed to detect if there is aspiration due to dysphagia. The signs are: cough, decrease in basal oxygen saturation greater than 5%, change in tone of voice and/or alteration in efficacy such as insufficient lip seal, oral or pharyngeal residuals and fractional swallowing.
The test consists of three textures (water, nectar and pudding) with three volumes (5 ml, 10 ml and 20 ml). It begins by administering (5ml of nectar texture), if any sign is found that compromises safety, it will not go to a higher volume or lower viscosity. It is concluded that there is no dysphagia when there are no signs of safety or altered efficacy at any time of the test.
Measured: Before entering the study.
Variable: Dependence to perform activities of daily living.
Ordinal quantitative variable. It is defined as the generic measure that assesses the patient's level of independence with respect to performing some basic activities of daily living. Measured by the Barthel Scale.
It consists of 10 items, with different possible answers. Values from 0 points (total dependency) to 100 points (independent) < 20 total dependency; 20-35 severe dependency; 40-55 Moderate dependency; ≥ 60 mild dependency; 100 independent
Measured: At study entry; At 3 months after entering the study; At 12 months after entering the study
Variable: Anxiety.
Qualitative variable. It is defined by the Medical Subject Headings (MeSH) "as feelings or emotions of fear, apprehension and impending disaster but not disabling as with anxiety disorders". It is measured by the Goldberg scale (Assessment of the Anxiety subscale) It consists of 10 items, its assessment ranges from 0 (no problem) to 10 points (severe anxiety) The cut-off points are 4 or more for the anxiety subscale
Measured: At study entry; At 3 months after entering the study; At 12 months after entering the study
Variable: Burden.
Qualitative variable. It is defined as "as the caregiver's subjective experience of care demands, it is a multidimensional concept, with objective and subjective characteristics. The objective burden corresponds to the changes that the caregiver must make in various areas of life and the subjective burden refers to the emotional reactions to the demands of care". It is measured by the Zarit scale (Assessment of caregiver burden) It consists of 22 items, with five possible answers. Maximum score of 88 points. A score below 46 is usually considered indicative of "no overload", and a score above 56 of "severe overload".
Measured: At study entry; At 3 months after entering the study; At 12 months after entering the study
Secondary outcomes (2)
Variable: Level of Oropharyngeal Dysphagia.
Discrete quantitative variable. Coded as (level 1: severe dysphagia, novel 2: moderate-severe dysphagia, level 3: moderate dysphagia, level 4: mild-moderate dysphagia, novel 5: mild dysphagia, level 6: diet-modified functional swallowing, level 7, swallowing normal). It is defined as, "systematically rating the functional severity of dysphagia based on an objective assessment and making recommendations for the level of diet, level of independence, and type of nutrition" Measured with the Dysphagia Outcome and Severity Scale (DOSS).
Measured: At study entry; At 3 months after entering the study; At 12 months after entering the study
Variable: Diet adherence
Qualitative. Coded as (non-adherence, sequential, sporadic, partial or good). The WHO defines it as "the degree to which a patient's behavior, in relation to taking medication, following a diet or modifying lifestyle habits, corresponds to the recommendations agreed with the health professional" (World Health Organization). Health Organization 2003). Measured through the adherence questionnaire for dietary adaptations in dysphagia.
Measured: At 3 months after entering the study; At 12 months after entering the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start30 May 2019
- Primary completion30 May 2020
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María Yuste Font, Universitat Internacional de Catalunya
- Investigators
- Alberto Gallart Fernández-Puebla, nursing, Study director, Universitat Internacional de CatalunyaMaría Ángeles de Juan Pardo, nursing, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405829
- Sponsor's protocol ID
- INF-2018-08
- Acronym
- HECGPN
- Status last verified
- Mar 2023
- First submitted
- 18 May 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boccardi V, Ruggiero C, Patriti A, Marano L. Diagnostic Assessment and Management of Dysphagia in Patients with Alzheimer's Disease. J Alzheimers Dis. 2016;50(4):947-55. doi: 10.3233/JAD-150931.
PubMed 26836016Nakamura K. [Aspiration pneumonia in elderly stroke patients in a convalescent rehabilitation ward: Risk factors and effects on recovery after stroke]. Nihon Ronen Igakkai Zasshi. 2020;57(1):45-52. doi: 10.3143/geriatrics.57.45. Japanese.
PubMed 32074560Hopwood J, Walker N, McDonagh L, Rait G, Walters K, Iliffe S, Ross J, Davies N. Internet-Based Interventions Aimed at Supporting Family Caregivers of People With Dementia: Systematic Review. J Med Internet Res. 2018 Jun 12;20(6):e216. doi: 10.2196/jmir.9548.
PubMed 29895512
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention for Caregivers of the Elderly With Cognitive Impairment and Risk of Bronchial Aspiration, to Reduce Episodes of Pneumonia. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05405829
- Acronym / sponsor ID
- HECGPN / INF-2018-08
- Conditions
- Oropharyngeal Dysphagia, Pneumonia, Malnutrition
- Keywords
- Elderly, Swallowing Disorders, pneumonia, caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized clinical study with a control group for assessing the decrease in the incidence of pneumonia, in a 12-month follow-up, in older people with cognitive impairment, risk of bronchial aspiration, risk of malnutrition and dependence to perform basic activities of daily living, through the design and implementation of an educational program. to the caregivers of these patients.
Detailed description
Introduction: The number of people over 65 years of age is increasing, observing an older population worldwide. In the year 2050 there will be 2,000 million, this situation is due to medical and technological advances, in addition to the declining birth rate. People live longer, but there is also a higher incidence of chronic diseases, associated with age. Among them, neurodegenerative diseases stand out, due to the dependence they entail, as well as the risk of situations such as episodes of bronchial aspiration, which can cause pneumonia that will require hospital admissions, as well as the risk of malnutrition and dependence to carry out basic activities of daily life. .
Most of these patients are cared for at home by their caregivers, who, in addition to not knowing how to care for oropharyngeal dysphagia, the situation of prolonged fatigue can generate overload and anxiety for the caregiver.
Objective: To evaluate the decrease in the incidence of pneumonia, in a 12-month follow-up, in older adults with cognitive impairment, risk of bronchial aspiration, risk of malnutrition and dependence to carry out basic activities of daily living, through the design and implementation of a educational program. to the caregivers of these patients.
Methodology: A sequential exploratory mixed study will be carried out. For the design of the educational intervention, a descriptive qualitative study will be carried out with focus groups of caregivers and the recommendations of the Health Literacy model will be followed. To evaluate the efficacy of this intervention, a pre-post intervention randomized clinical trial with a control group will be carried out. The sample will be 178 couples made up of caregivers (formal or informal non-professional caregivers) and people over 65 who are in their care. The study will be carried out at the Parc Sanitari Per Virgili in Barcelona from May 2019 to March 2023. The main variables and study instruments are the incidence and admissions for pneumonia, as well as its delay in onset in older people, measured by Clinical history, cognitive impairment, measured with the Pfeiffer test, the risk of bronchial aspiration measured with the volumetric viscosity exploratory method test (V-VST), the risk of malnutrition measured with the Mini Nutritional Assessment short-form scale (MNA- SF). In addition to the anxiety and overload of their caregivers, measured with the Goldberg and Zarit scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Health educationConventional information received by caregivers. The speech therapist comes to the room to pass the Volume viscosity exploratory method test (V-VST) Test and after confirming dysphagia, informs the patient of the test result and delivers a booklet of recommendations. |
| Intervention group | Experimental | Other: Health educationA 45-minute session, hygienic-dietary training, with visual support and work materials where three specific interventions are explained: textures for solids and liquids, safety postures to reduce the risk of bronchial aspiration, and oral hygiene. In addition, tools are offered to caregivers so that they can identify situations of anxiety and overload, as well as guidelines for social support. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health educationtheoretical-practical hygienic-dietary training, with visual support and work materials where three specific interventions are explained: textures for solids and liquids, safety postures to reduce the risk of bronchial aspiration, and oral hygiene. In addition, tools are offered to caregivers so that they can identify situations of anxiety and overload, as well as guidelines for social support. | Other | Control group, Intervention group |
Primary outcome
Variable: pneumonia.
Time frame: At 12 months before entering the study; At 3 months before entering the study; At 3 months after entering the study; At 12 months after entering the study
Qualitative variable, dichotomous (yes/no). Pneumonia is defined according to the International Classification of Diseases of the lungs (ICD 11), often caused by infection by bacteria, viruses, fungi or parasites, although not always. It is characterized by fever, chills, productive cough, chest pain, and dyspnea" (WHO 2022). Measured through self-prepared questionnaire and Clinical History.
Variable: time of onset of pneumonia.
Time frame: At 3 months after entering the study; At 12 months after entering the study.
Discrete quantitative variable. The elapsed time measured in months from the intervention to the appearance of the first pneumonia is considered.
Variable: Admission for pneumonia in the last year.
Time frame: At 3 months after entering the study; At 12 months after entering the study.
Qualitative, dichotomous variable (yes/no). Measured through own questionnaire.
Variable: Number of admissions for pneumonia in the last year.
Time frame: At 12 months before entering the study; At 3 months before entering the study; At 3 months after entering the study; At 12 months after entering the study
Discrete numerical quantitative variable. Measured through the Clinic History and own questionnaire.
Variable: Malnutrition risk.
Time frame: At study entry; At 3 months after entering the study; At 12 months after entering the study
Continuous quantitative variable. It is defined as "an unbalanced nutritional state resulting from insufficient nutrient intake to meet normal physiological requirements". Measured with Scale Mini Nutritional Assessment-Short Form (MNA-SF). Through the Clinic History and own questionnaire. Scale to assess malnutrition (maximum score of 14 points). 12-14 points: normal nutritional status; 8-11 points: risk of malnutrition; 0-7 points: malnutrition.
Variable: Cognitive impairment.
Time frame: At study entry; At 3 months after entering the study; At 12 months after entering the study
Discrete quantitative variable. Cognitive impairment is defined according to the Medical Subject Headings (MeSH) descriptor, as "the decrease or deterioration of mental and/or intellectual function". Measured with Pfeiffer test. Pfeiffer scale, It consists of 10 items. Between 0-2: it is considered normal; Between 3-4: mild cognitive impairment Between 5-7: moderate cognitive impairment; More than 8 errors: severe cognitive impairment.
Variable: Risk of Bronchoaspiration.
Time frame: Before entering the study.
Discrete quantitative variable. It is defined as "A type of pulmonary inflammation resulting from the aspiration of food, liquid, or gastric contents into the upper respiratory tract." Measured with the volume-viscosity swallow test (V-VST). Test performed to detect if there is aspiration due to dysphagia. The signs are: cough, decrease in basal oxygen saturation greater than 5%, change in tone of voice and/or alteration in efficacy such as insufficient lip seal, oral or pharyngeal residuals and fractional swallowing. The test consists of three textures (water, nectar and pudding) with three volumes (5 ml, 10 ml and 20 ml). It begins by administering (5ml of nectar texture), if any sign is found that compromises safety, it will not go to a higher volume or lower viscosity. It is concluded that there is no dysphagia when there are no signs of safety or altered efficacy at any time of the test.
Variable: Dependence to perform activities of daily living.
Time frame: At study entry; At 3 months after entering the study; At 12 months after entering the study
Ordinal quantitative variable. It is defined as the generic measure that assesses the patient's level of independence with respect to performing some basic activities of daily living. Measured by the Barthel Scale. It consists of 10 items, with different possible answers. Values from 0 points (total dependency) to 100 points (independent) < 20 total dependency; 20-35 severe dependency; 40-55 Moderate dependency; ≥ 60 mild dependency; 100 independent
Variable: Anxiety.
Time frame: At study entry; At 3 months after entering the study; At 12 months after entering the study
Qualitative variable. It is defined by the Medical Subject Headings (MeSH) "as feelings or emotions of fear, apprehension and impending disaster but not disabling as with anxiety disorders". It is measured by the Goldberg scale (Assessment of the Anxiety subscale) It consists of 10 items, its assessment ranges from 0 (no problem) to 10 points (severe anxiety) The cut-off points are 4 or more for the anxiety subscale
Variable: Burden.
Time frame: At study entry; At 3 months after entering the study; At 12 months after entering the study
Qualitative variable. It is defined as "as the caregiver's subjective experience of care demands, it is a multidimensional concept, with objective and subjective characteristics. The objective burden corresponds to the changes that the caregiver must make in various areas of life and the subjective burden refers to the emotional reactions to the demands of care". It is measured by the Zarit scale (Assessment of caregiver burden) It consists of 22 items, with five possible answers. Maximum score of 88 points. A score below 46 is usually considered indicative of "no overload", and a score above 56 of "severe overload".
2 secondary outcomes
Variable: Level of Oropharyngeal Dysphagia.
Time frame: At study entry; At 3 months after entering the study; At 12 months after entering the study
Variable: Diet adherence
Time frame: At 3 months after entering the study; At 12 months after entering the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Results publication: PubMed 26836016Boccardi V, Ruggiero C, Patriti A, Marano L. Diagnostic Assessment and Management of Dysphagia in Patients with Alzheimer's Disease. J Alzheimers Dis. 2016;50(4):947-55. doi: 10.3233/JAD-150931.
- Results publication: PubMed 32074560Nakamura K. [Aspiration pneumonia in elderly stroke patients in a convalescent rehabilitation ward: Risk factors and effects on recovery after stroke]. Nihon Ronen Igakkai Zasshi. 2020;57(1):45-52. doi: 10.3143/geriatrics.57.45. Japanese.
- Results publication: PubMed 29895512Hopwood J, Walker N, McDonagh L, Rait G, Walters K, Iliffe S, Ross J, Davies N. Internet-Based Interventions Aimed at Supporting Family Caregivers of People With Dementia: Systematic Review. J Med Internet Res. 2018 Jun 12;20(6):e216. doi: 10.2196/jmir.9548.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Gallart Fernández-Puebla, nursing study director
Universitat Internacional de Catalunya
María Ángeles de Juan Pardo, nursing study director
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education in people with Oropharyngeal Dysphagia and Pneumonia, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variable: pneumonia. (time frame: At 12 months before entering the study; At 3 months before entering the study; At 3 months after entering the study; At 12 months after entering the study). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05405829, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.