The nursing process consists of establishing interventions applying the scientific method for the resolution of real or potential health problems of the person, based on five stages: assessment, diagnosis, planning, execution and evaluation, which allows detecting the circumstances and elements that affect the adult's independence and the influence he has on his environment, his quality of life, his family, social and psychological role.
MATERIAL AND METHODS: Clinical trial, randomized, controlled with standard management; to evaluate the effect of the nursing process on the quality of life in elderly patients who come or are referred to the Cardiology Hospital, National Medical Century XXI, with alterations in the ventricular atrial conduction and require the installation of a permanent pacemaker. The first evaluation (Time 0) will be carried out through an interview with the SF36 instrument, translated into several languages and applied to multiple studies in Mexico for validation. Two groups will be formed for comparison: Group I will be assigned to standard management; Group II: group of patients who are also treated through the nursing process with the model of Marjory Gordon with the intervention Handling the definitive pacemaker with education and information activities. It will be verified for quality control of the maneuver; through a checklist. As a final point, the quality of life will be evaluated through the use of the SF36 instrument that consists of 36 items that explore 8 dimensions of the state of physical health, physical function, physical role, body pain, general health, vitality, social function, emotional role and mental health: considering depression, anxiety, self-control, and general well-being; applying the assessment system of the functional patterns of the Marjory Gordon model, through surveys. Statistical analysis: Chi square or Fisher's exact test will be used according to expected values, for qualitative variables. For quantitative variables, the Mann Whitney U or Student's T according to their distribution. There will be a calculation of the number needed to be treated, and a multivariate analysis will be carried out using a binary logistic regression.
Condition or disease | Intervention/treatment | Phase |
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Quality of Life | Other: Educational Other: Maneuver control | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Control group and intervention group, were selected randomly from consecutive cases and standard management |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Health Services Research |
Official Title: | Effect of the Nursing Process Through Functional Patterns on the Quality of Life of the Elderly Adult Patient With Definitive Pacemaker Implantation |
Actual Study Start Date : | June 25, 2016 |
Actual Primary Completion Date : | July 25, 2017 |
Actual Study Completion Date : | June 25, 2018 |
Arm | Intervention/treatment |
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Experimental: INSTRUMENT SF 36
Instrument SF36 Spanish version, validated in Spain, translated in several languages and applied to multiple studios in Mexico. The 36 items explore 8 dimensions: the state of physical health, physical function, physical role, body pain, general health, vitality, social function, emotional role and mental health: considering depression, anxiety, self-control, and general well-being.
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Other: Educational
Traditional method of nursing care with what is done every day, with the method through the nursing process using nursing language as a nursing diagnosis, classification of nursing interventions, and nursing outcomes.
Other: Maneuver control Verify that the control and intervention group developed the assigned activities in each case.
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Active Comparator: Checklist
Verify that the interventions of both groups were carried out
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Other: Educational
Traditional method of nursing care with what is done every day, with the method through the nursing process using nursing language as a nursing diagnosis, classification of nursing interventions, and nursing outcomes.
Other: Maneuver control Verify that the control and intervention group developed the assigned activities in each case.
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Ages Eligible for Study: | 60 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Principal Investigator: | SONIA GONZALEZ MEJORADA | Instituto Mexicano del Seguro Social |
Tracking Information | |||||
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First Submitted Date ICMJE | June 23, 2019 | ||||
First Posted Date ICMJE | June 27, 2019 | ||||
Last Update Posted Date | June 27, 2019 | ||||
Actual Study Start Date ICMJE | June 25, 2016 | ||||
Actual Primary Completion Date | July 25, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Effect of the Nursing Process Through Functional Patterns on the Quality of Life of the Elderly Adult Patient With Definitive Pacemaker Implantation [ Time Frame: one year ] To determine the effect of the nursing process through the functional patterns on the quality of life of the elderly adult patient with definitive pacemaker implantation.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of the Nursing Process on the Quality of Life of the Patient With Definitive Pacemaker Implantation | ||||
Official Title ICMJE | Effect of the Nursing Process Through Functional Patterns on the Quality of Life of the Elderly Adult Patient With Definitive Pacemaker Implantation | ||||
Brief Summary |
The nursing process consists of establishing interventions applying the scientific method for the resolution of real or potential health problems of the person, based on five stages: assessment, diagnosis, planning, execution and evaluation, which allows detecting the circumstances and elements that affect the adult's independence and the influence he has on his environment, his quality of life, his family, social and psychological role. MATERIAL AND METHODS: Clinical trial, randomized, controlled with standard management; to evaluate the effect of the nursing process on the quality of life in elderly patients who come or are referred to the Cardiology Hospital, National Medical Century XXI, with alterations in the ventricular atrial conduction and require the installation of a permanent pacemaker. The first evaluation (Time 0) will be carried out through an interview with the SF36 instrument, translated into several languages and applied to multiple studies in Mexico for validation. Two groups will be formed for comparison: Group I will be assigned to standard management; Group II: group of patients who are also treated through the nursing process with the model of Marjory Gordon with the intervention Handling the definitive pacemaker with education and information activities. It will be verified for quality control of the maneuver; through a checklist. As a final point, the quality of life will be evaluated through the use of the SF36 instrument that consists of 36 items that explore 8 dimensions of the state of physical health, physical function, physical role, body pain, general health, vitality, social function, emotional role and mental health: considering depression, anxiety, self-control, and general well-being; applying the assessment system of the functional patterns of the Marjory Gordon model, through surveys. Statistical analysis: Chi square or Fisher's exact test will be used according to expected values, for qualitative variables. For quantitative variables, the Mann Whitney U or Student's T according to their distribution. There will be a calculation of the number needed to be treated, and a multivariate analysis will be carried out using a binary logistic regression. |
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Detailed Description |
Patients admitted to the Cardiology Hospital, National Medical Center Century XXI, will be included and a permanent pacemaker will be installed due to alterations in atrio-ventricular conduction that meet the selection criteria. They will be explained what the research consists of and they will be given an informed consent form to participate in the study, with all the ethical considerations that we will discuss later. they require to control their comorbidities according to the assessment of their treating physician. Having accepted their participation in the present research project, the first evaluation (Time 0) will be conducted through an interview with the instrument SF36 Spanish version containing a total of 36 questions, translated into several languages and applied to multiple studies in Mexico for its validation. The interview will be conducted in two parts and will last approximately 15 to 20 minutes. Once the first evaluation has been carried out, they will randomly assign, through the use of random number tables, to receive specific care from the nursing staff in the following manner: I. Group of conventional nursing intervention (Group I) that refers to the form performed up to now, hemodynamic assessment, local pacemaker verification, electrocardiographic tracing, surveillance and care of the incision, assessment of symptoms after the insertion of the pacemaker, risks and interferences, mobilization and posture, complications, care information and identification of other needs of the elderly in terms of mobility, degree of dependency, pain assessment, elimination, nutritional, rest and relationship difficulties family, work, emotional conflicts, values and religiosity in some cases. II. Nursing intervention group through the nursing process with the Marjory Gordon system (Group II).
To evaluate the response of patients to nursing interventions in their quality of life, the following will be done: 1. Before discharge from hospital, verification of quality control of the maneuver will be carried out, using a checklist, on the indications given by the nursing staff to the patient. 2. One month after the patient's hospital discharge, during which patients are regularly scheduled for follow-up consultation, after their routine medical assessment, an interview will be conducted where we will make a total of 36 questions with 3 to 5 answer options each, with the SF36 instrument. The 36 items explore 8 dimensions of the state of physical health, physical function, physical role, body pain, general health, vitality, social function, emotional role and mental health: considering depression, anxiety, self-control, and general well-being; applying the assessment system of the functional patterns of the Marjory Gordon model, through surveys. The interview will be conducted in two parts and will last approximately 15 to 20 minutes. (Outcome) The system by Functional Employers focuses its attention on 11 items with importance for the health of the individual, family or community.
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Control group and intervention group, were selected randomly from consecutive cases and standard management Masking: Double (Participant, Care Provider)Primary Purpose: Health Services Research |
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Condition ICMJE | Quality of Life | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
400 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | June 25, 2018 | ||||
Actual Primary Completion Date | July 25, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years to 90 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03999671 | ||||
Other Study ID Numbers ICMJE | R-2013-3604-7 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Sonia Gonzalez Mejorada, Instituto Mexicano del Seguro Social | ||||
Study Sponsor ICMJE | Instituto Mexicano del Seguro Social | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Instituto Mexicano del Seguro Social | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |