Health Services for the AgedNCT04997746
Educational Guidelines Aimed at Pre-frail Elderly: Intervention Proposal
An observational study of Health Services for the Aged and Geriatrics, run by Leonardo Paroche de Matos at 1 site in Brazil.
Trial summary
INTRODUCTION: aging is the natural process of deterioration of the reserves of biological systems, human beings are inherent to this process. The elderly population in Brazil grows very quickly, this is due to the drop in fertility, mortality and increased life expectancy. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Services for the Aged, Geriatrics
- What is being tested?
- Multiprofessional educational interventions and Measurement of anthropometric measurements
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2021to Jan 2022
- Phase
- Observational
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly participants previously classified as pre-frail based on the Multidimensional Assessment of the Elderly instrument
Who may be able to join
- Time and space oriented seniors;
- Previously classified as pre-fragile;
- Good physical condition for taking anthropometric measurements;
- Who voluntarily agreed to participate in the research;
Who cannot join
- Elderly classified as "healthy";
- Unsatisfactory physical condition that makes it impossible to measure anthropometric measurements;
- Elderly with amputated limbs;
- In palliative care;
- Who refuse to voluntarily participate in the research
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Guarulhos City Hall
Guarulhos, São Paulo, 07175530
Leonardo Matos, +55112453168, leonardoparoche@gmail.com
Leonardo Matos, +551124532168, leonardoparoche@gmail.com
About this study
Official title: Educational Guidelines Aimed at Pre-frail Elderly From a Family Health Unit, Guarulhos/SP - an Intervention Proposal
INTRODUCTION: aging is the natural process of deterioration of the reserves of biological systems, human beings are inherent to this process. The elderly population in Brazil grows very quickly, this is due to the drop in fertility, mortality and increased life expectancy. OBJECTIVE: to promote the planning of guiding and educational actions based on the qualification of the frailty of the elderly in the Basic Health Unit of the study through the use of the Multidimensional Assessment of the Elderly in Primary Care (AMPI/AB) tool. METHODOLOGY: an experimental, longitudinal, prospective and analytical study aimed at approximately 20 pre-frail elderly people residing in a specific area of a Family Health Unit in the city of Guarulhos/SP. A survey of data referring to the application of AMPI/AB carried out in 2021 and classified as pre-fragile will be carried out, in order to later select them for research. The participant will receive educational guidance on nutrition, use of medications and nursing guidance as identified as needs. Three months after the intervention, AMPI/AB will be applied in order to observe whether the pre-frail elderly remained or changed category after the experimental multidisciplinary educational interventions.
Read the detailed description
Experimental, longitudinal, prospective and analytical study aimed at pre-frail elderly people living in a specific area of a Family Health Unit in the city of Guarulhos/SP, developed with the aim of qualifying the health care of the elderly population of the territory of the Basic health Unit in 2021, using the Multidimensional Assessment of the Elderly in Primary Care (MAE/PC questionnaire) as the main data collection instrument, associated with the multidisciplinary educational intervention. Initially, a survey of data referring to MAE/PC carried out in 2021 will be carried out during the routine of care by the authors, in order to identify the elderly who were classified as pre-frail. Data referring to healthy and frail elderly people will be used in the research in a descriptive (quantitative) way. Participants will not be identified, data will be displayed in absolute numbers and frequency.
The educational activities will be carried out through home visits and collection of anthropometric measurements, at which time the Informed Consent Form will be offered to authorize participation in the research. The reference participant and/or caregiver will receive all the necessary information to consciously decide whether or not to participate in the aforementioned research and is free to withdraw at any time, which will not harm any of the parties involved. Participants will also receive educational guidance on nutrition, medication use and nursing guidance as identified as needed.
Three months after the intervention, the MAE/PC questionnaire will be reapplied in order to verify if the participant kept or changed his category after receiving the multidisciplinary recommendations.
- Conditions
- Health Services for the Aged, Geriatrics
- Being tested
- Multiprofessional educational interventions, Measurement of anthropometric measurements
- Keywords
- Elderly health, Patient Care Team, Family health strategy, Primary Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiprofessional educational interventionsBehavioural
Preventive educational interventions
Measurement of anthropometric measurementsOther
Measurement of height (in meters), weight (in kilograms), knee height, arm circumference and calf circumference (in centimeters)
| Study group | Role | What they receive |
|---|---|---|
| educational pharmaceutical guidelines | Qualified listening of participants; General pharmaceutical educational guidelines on the use of medicines; Manufacture and supply of medicine organizer boxes. Receives: Behavioral: Multiprofessional educational interventions | |
| Nursing Educational Guidelines | Nursing educational guidelines; Qualified listening to participants to resolve doubts related to their comorbidities and aging, bringing comfort in relation to their anxieties.
Nursing interventions will occur through verbal educational guidelines given individually and according to the reality of each participant assessed by the research, based on the nursing diagnoses obtained from the North American Nursing Diagnosis Association - NANDA-I (definitions and classification 2018- 2020) 11th edition. Receives: Behavioral: Multiprofessional educational interventions | |
| Nutritional Educational Guidelines | Obtaining anthropometric measurements (weight, in kilograms, height (in meters), knee height, arm and calf circumference (in centimeters) to trace the participant's nutritional profile and, subsequently, personalized and appropriate nutritional guidelines will be carried out for each situation The calculation of the Body Mass Index (BMI) must be performed by dividing the weight (W) in kilograms (kg) by the square of the height (H) in meters (m) and indicates the individual's nutritional status. The BMI for the elderly (LIPSCHITZ, 1994 apud TAVARES et al., 2015) determines underweight less than or equal to 22kg / m2, adequate or eutrophic weight between 22 and 27kg / m2 and overweight result greater than or equal to 27kg / m2 . Receives: Behavioral: Multiprofessional educational interventions; Other: Measurement of anthropometric measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct use of medications
Adequacy of the correct use of medications with the use of the medication box. subjective outcome
Measured: 3 months
Advances in quality of life (subjective)
Offering guidelines on the health of the elderly, providing them with healthier aging and quality of life, covering critical points of the elderly's health and preventing health problems, providing advances in their self-care and giving them more autonomy, solving doubts related to their comorbidities and the aging process, bringing comfort to their anguish, also including the process of death. Subjective outcome
Measured: 3 months
Calculation of Body Mass Index
Elderly people are expected to remain within the anthropometric parameters according to their age group, based on the calculation of BMI in kg / m ^ 2 (obtained by combining weight (in kilograms) and height (in meters)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services for the AgedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leonardo Paroche de Matos
- Sponsor type
- University, hospital or other
- Collaborators
- Jadhy Aquino Antunes, Bianca Prado de Lima Ramos, Daniele Fernanda Mantovani, Milla de Castro, Victória Sanches Pereira Gimenez
- Responsible party
- Sponsor-investigator, Leonardo Paroche de Matos, Leonardo Paroche de Matos
- Investigators
- Leonardo Matos, Study director, Guarulhos City Hall
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997746
- Sponsor's protocol ID
- 20210724
- Status last verified
- Aug 2021
- First submitted
- 24 Jul 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Guidelines Aimed at Pre-frail Elderly From a Family Health Unit, Guarulhos/SP - an Intervention Proposal
- ClinicalTrials.gov ID
- NCT04997746
- Acronym / sponsor ID
- 20210724
- Conditions
- Health Services for the Aged, Geriatrics
- Keywords
- Elderly health, Patient Care Team, Family health strategy, Primary Health Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Leonardo Paroche de MatosUniversity, hospital or other
- Collaborators
- Jadhy Aquino Antunes, Bianca Prado de Lima Ramos, Daniele Fernanda Mantovani, Milla de Castro, Victória Sanches Pereira Gimenez
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 10 Aug 2021 (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.
INTRODUCTION: aging is the natural process of deterioration of the reserves of biological systems, human beings are inherent to this process. The elderly population in Brazil grows very quickly, this is due to the drop in fertility, mortality and increased life expectancy. OBJECTIVE: to promote the planning of guiding and educational actions based on the qualification of the frailty of the elderly in the Basic Health Unit of the study through the use of the Multidimensional Assessment of the Elderly in Primary Care (AMPI/AB) tool. METHODOLOGY: an experimental, longitudinal, prospective and analytical study aimed at approximately 20 pre-frail elderly people residing in a specific area of a Family Health Unit in the city of Guarulhos/SP. A survey of data referring to the application of AMPI/AB carried out in 2021 and classified as pre-fragile will be carried out, in order to later select them for research. The participant will receive educational guidance on nutrition, use of medications and nursing guidance as identified as needs. Three months after the intervention, AMPI/AB will be applied in order to observe whether the pre-frail elderly remained or changed category after the experimental multidisciplinary educational interventions.
Detailed description
Experimental, longitudinal, prospective and analytical study aimed at pre-frail elderly people living in a specific area of a Family Health Unit in the city of Guarulhos/SP, developed with the aim of qualifying the health care of the elderly population of the territory of the Basic health Unit in 2021, using the Multidimensional Assessment of the Elderly in Primary Care (MAE/PC questionnaire) as the main data collection instrument, associated with the multidisciplinary educational intervention. Initially, a survey of data referring to MAE/PC carried out in 2021 will be carried out during the routine of care by the authors, in order to identify the elderly who were classified as pre-frail. Data referring to healthy and frail elderly people will be used in the research in a descriptive (quantitative) way. Participants will not be identified, data will be displayed in absolute numbers and frequency.
The educational activities will be carried out through home visits and collection of anthropometric measurements, at which time the Informed Consent Form will be offered to authorize participation in the research. The reference participant and/or caregiver will receive all the necessary information to consciously decide whether or not to participate in the aforementioned research and is free to withdraw at any time, which will not harm any of the parties involved. Participants will also receive educational guidance on nutrition, medication use and nursing guidance as identified as needed.
Three months after the intervention, the MAE/PC questionnaire will be reapplied in order to verify if the participant kept or changed his category after receiving the multidisciplinary recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| educational pharmaceutical guidelines | – | Behavioral: Multiprofessional educational interventionsQualified listening of participants; General pharmaceutical educational guidelines on the use of medicines; Manufacture and supply of medicine organizer boxes. |
| Nursing Educational Guidelines | – | Behavioral: Multiprofessional educational interventionsNursing educational guidelines; Qualified listening to participants to resolve doubts related to their comorbidities and aging, bringing comfort in relation to their anxieties. Nursing interventions will occur through verbal educational guidelines given individually and according to the reality of each participant assessed by the research, based on the nursing diagnoses obtained from the North American Nursing Diagnosis Association - NANDA-I (definitions and classification 2018- 2020) 11th edition. |
| Nutritional Educational Guidelines | – | Behavioral: Multiprofessional educational interventions, Other: Measurement of anthropometric measurementsObtaining anthropometric measurements (weight, in kilograms, height (in meters), knee height, arm and calf circumference (in centimeters) to trace the participant's nutritional profile and, subsequently, personalized and appropriate nutritional guidelines will be carried out for each situation The calculation of the Body Mass Index (BMI) must be performed by dividing the weight (W) in kilograms (kg) by the square of the height (H) in meters (m) and indicates the individual's nutritional status. The BMI for the elderly (LIPSCHITZ, 1994 apud TAVARES et al., 2015) determines underweight less than or equal to 22kg / m2, adequate or eutrophic weight between 22 and 27kg / m2 and overweight result greater than or equal to 27kg / m2 . |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly participants previously classified as pre-frail based on the Multidimensional Assessment of the Elderly instrument
Key inclusion criteria (4 listed)
- Time and space oriented seniors;
- Previously classified as pre-fragile;
- Good physical condition for taking anthropometric measurements;
- Who voluntarily agreed to participate in the research;
Key exclusion criteria (5 listed)
- Elderly classified as "healthy";
- Unsatisfactory physical condition that makes it impossible to measure anthropometric measurements;
- Elderly with amputated limbs;
- In palliative care;
- Who refuse to voluntarily participate in the research
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 |
|---|---|---|
| Multiprofessional educational interventionsPreventive educational interventions | Behavioural | Nursing Educational Guidelines, Nutritional Educational Guidelines, educational pharmaceutical guidelines |
| Measurement of anthropometric measurementsMeasurement of height (in meters), weight (in kilograms), knee height, arm circumference and calf circumference (in centimeters) | Other | Nutritional Educational Guidelines |
Primary outcome
Correct use of medications
Time frame: 3 months
Adequacy of the correct use of medications with the use of the medication box. subjective outcome
Advances in quality of life (subjective)
Time frame: 3 months
Offering guidelines on the health of the elderly, providing them with healthier aging and quality of life, covering critical points of the elderly's health and preventing health problems, providing advances in their self-care and giving them more autonomy, solving doubts related to their comorbidities and the aging process, bringing comfort to their anguish, also including the process of death. Subjective outcome
Calculation of Body Mass Index
Time frame: 3 months
Elderly people are expected to remain within the anthropometric parameters according to their age group, based on the calculation of BMI in kg / m ^ 2 (obtained by combining weight (in kilograms) and height (in meters)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
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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.
Leonardo Matos study director
Guarulhos City Hall
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Services for the Aged and Geriatrics, run by Leonardo Paroche de Matos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 16 Aug 2021. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo Matos (+551124532168, leonardoparoche@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct use of medications (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2021.