- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04997746
Educational Guidelines Aimed at Pre-frail Elderly: Intervention Proposal
Educational Guidelines Aimed at Pre-frail Elderly From a Family Health Unit, Guarulhos/SP - an Intervention Proposal
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Leonardo Matos
- Phone Number: +551124532168
- Email: leonardoparoche@gmail.com
Study Locations
-
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São Paulo
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Guarulhos, São Paulo, Brazil, 07175530
- Guarulhos City Hall
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Contact:
- Leonardo Matos
- Phone Number: +551124532168
- Email: leonardoparoche@gmail.com
-
Contact:
- Leonardo Matos
- Phone Number: +55112453168
- Email: leonardoparoche@gmail.com
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Principal Investigator:
- Leonardo Matos
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
educational pharmaceutical guidelines
Qualified listening of participants; General pharmaceutical educational guidelines on the use of medicines; Manufacture and supply of medicine organizer boxes.
|
Preventive 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. |
Preventive 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 .
|
Preventive educational interventions
Measurement of height (in meters), weight (in kilograms), knee height, arm circumference and calf circumference (in centimeters)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correct use of medications
Time Frame: 3 months
|
Adequacy of the correct use of medications with the use of the medication box.
subjective outcome
|
3 months
|
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
|
3 months
|
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)
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Leonardo Matos, Guarulhos City Hall
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20210724
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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