Quality of LifeNCT03999671
Effect of the Nursing Process on the Quality of Life of the Patient With Definitive Pacemaker Implantation
A study testing Educational in people with Quality of Life, run by Instituto Mexicano del Seguro Social.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Educational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2016to 25 Jun 2018
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over 60 years old
- Any gender
- That require the placement of a definitive pacemaker either by endocardial or epicardial route and do not present any complication during its installation and hospital stay.
- Signature of informed consent in writing of acceptance to enter the study
Who cannot join
- Older adults with neurological problems.
- Patients with other aggregate pathologies different from atrio-ventricular conduction abnormalities such as valvular diseases, myocardial infarction, congenital diseases, postoperative atrio-ventricular blocks, neoplastic diseases, end-stage renal disease.
- Generator depletion.
- Endocarditis.
- Chronic degenerative diseases whose life expectancy is less than 2 years.
- Previous pacemaker carrier and that you enter for replacement.
About this study
Official title: Effect of the Nursing Process Through Functional Patterns on the Quality of Life of the Elderly Adult Patient With Definitive Pacemaker Implantation
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.
Read the 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:
- 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).
- Starting with the assessment stage by functional patterns: health perception-management, nutrition, elimination, activity and rest, sleep and rest, perceptual cognitive, self-concept-self-perception, role-relationships, sexuality-reproduction, coping-tolerance of stress, values and beliefs and the quality of life.
- Following the diagnostic stage of nursing, the problem is identified through labels that define it as: Decrease in cardiac output, risk of bleeding, ineffective protection, acute pain, risk of imbalance of body temperature, deterioration of ambulation, deterioration of physical mobility, deterioration of gas exchange, disposition to improve one's health, sleep deprivation, deterioration of urinary elimination, constipation, self-care deficit, sensory perception disorder, deterioration of social interaction or conflict of decisions , hopelessness, low self-esteem, body image disorder, ineffective coping, anxiety, fear and hopelessness complementing the structure of the diagnosis with risk factors (for example: poor knowledge) and etiological (for example: altered frequency and heart rate) , as well as, with defining characteristics (signs and symptoms) that pre Say the problem.
- The planning stage will be carried out through expected results from the problems identified as nursing diagnoses and using the classification of expected nursing outcomes (NOC) each of them with a target score of maintaining results; will increase; and scales from severe to none, or from seriously compromised to uncommitted will depend on the proposed result. Decreased cardiac output The expected result will be effectiveness of the heart pump which will be measured with indicators such as: systolic blood pressure, diastolic blood pressure, heart rate , peripheral pulses. From the expected result, nursing interventions will be derived: Intervention "Cardiac care" with activities
- Observing vital signs frequently
- Monitor cardiovascular status
- Check and check the operation of the pacemaker,
- Instruct the patient on the importance of the immediate report of any chest discomfort.
- Take note of the significant signs and symptoms of decreased cardiac output. • Intervention "Management of the definitive pacemaker" with activities of <!-- -->
- Education on the potential risks of metabolic alterations (eg potential to increase the thresholds of rhythm or capture);
- The importance of attending their periodic checks;
- Sources of higher electromagnetic interference (eg arc welding equipment, radio transmitters, electronic muscle stimulators, concert loudspeakers, electric drills, hand-held metal detectors, magnetic resonance, radiotherapy).
- Keep about 15 cm away from cell phones;
- Signs and symptoms of a dysfunctional pacemaker (eg bradycardia, dizziness, weakness, fatigue, chest discomfort, angina, dyspnea, orthopnea, edema, paroxysmal nocturnal dyspnea, exertional dyspnea, hypotension, syncope, cardiac arrest)
- The importance of carrying the identification card of the manufacturer at all times.
- Information to the patient and the family related to the implantation of the pacemaker (eg, indications, functions, universal programming codes, potential complications); related to the effects of pacemaker treatment to reduce patient uncertainty, fear and anxiety about symptoms (eg dizziness, palpitations, chest pain, shortness of breath) related to treatment (arm edema or augmentation) of heat);
- Teach the patient to check the manufacturer's warnings when in doubt about electrical appliances.
- Fourth stage of the nursing process execution of nursing interventions (NIC) obtained through the expected results (NOC).
To evaluate the response of patients to nursing interventions in their quality of life, the following will be done:
- 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.
- 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.
- Ability of the person to identify their health status.
- Ability of the person to identify their nutritional needs.
- Identify the excretory function (intestinal, urinary and skin).
- Realization of the activities and exercise carried out by the person.
- Conciliar sleep activity
- Sensory alterations: Hearing, gustatory, tactile and olfactory views as well as the presence of pain.
- Form in which the patient feels, feelings, knowledge of himself.
- Way to live with others.
- It is experienced or expressed in the form of thoughts, fantasies, desires, beliefs, attitudes, values, activities, practices, roles and relationships.
- Way to handle stress.
- Values, beliefs that guide the decisions and choices of the individual.
- Conditions
- Quality of Life
- Being tested
- Educational, Maneuver control
- Keywords
- Effect, Nursing, Process, Functional, Patterns,health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationalOther
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.
Maneuver controlOther
Verify that the control and intervention group developed the assigned activities in each case.
| Study group | Role | What they receive |
|---|---|---|
| INSTRUMENT SF 36 | Experimental | 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. Receives: Other: Educational; Other: Maneuver control |
| Checklist | Active comparator | Verify that the interventions of both groups were carried out Receives: Other: Educational; Other: Maneuver control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the Nursing Process Through Functional Patterns on the Quality of Life of the Elderly Adult Patient With Definitive Pacemaker Implantation
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start25 Jun 2016
- Primary completion25 Jul 2017
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group and intervention group, were selected randomly from consecutive cases and standard management
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sonia Gonzalez Mejorada, Instituto Mexicano del Seguro Social
- Investigators
- SONIA GONZALEZ MEJORADA, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999671
- Sponsor's protocol ID
- R-2013-3604-7
- Status last verified
- Jun 2019
- First submitted
- 23 Jun 2019
- Last updated
- 27 Jun 2019
- 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 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Nursing Process Through Functional Patterns on the Quality of Life of the Elderly Adult Patient With Definitive Pacemaker Implantation
- ClinicalTrials.gov ID
- NCT03999671
- Acronym / sponsor ID
- R-2013-3604-7
- Conditions
- Quality of Life
- Keywords
- Effect, Nursing, Process, Functional, Patterns,health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 25 Jun 2016 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 27 Jun 2019 (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.
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.
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:
- 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).
- Starting with the assessment stage by functional patterns: health perception-management, nutrition, elimination, activity and rest, sleep and rest, perceptual cognitive, self-concept-self-perception, role-relationships, sexuality-reproduction, coping-tolerance of stress, values and beliefs and the quality of life.
- Following the diagnostic stage of nursing, the problem is identified through labels that define it as: Decrease in cardiac output, risk of bleeding, ineffective protection, acute pain, risk of imbalance of body temperature, deterioration of ambulation, deterioration of physical mobility, deterioration of gas exchange, disposition to improve one's health, sleep deprivation, deterioration of urinary elimination, constipation, self-care deficit, sensory perception disorder, deterioration of social interaction or conflict of decisions , hopelessness, low self-esteem, body image disorder, ineffective coping, anxiety, fear and hopelessness complementing the structure of the diagnosis with risk factors (for example: poor knowledge) and etiological (for example: altered frequency and heart rate) , as well as, with defining characteristics (signs and symptoms) that pre Say the problem.
- The planning stage will be carried out through expected results from the problems identified as nursing diagnoses and using the classification of expected nursing outcomes (NOC) each of them with a target score of maintaining results; will increase; and scales from severe to none, or from seriously compromised to uncommitted will depend on the proposed result. Decreased cardiac output The expected result will be effectiveness of the heart pump which will be measured with indicators such as: systolic blood pressure, diastolic blood pressure, heart rate , peripheral pulses. From the expected result, nursing interventions will be derived: Intervention "Cardiac care" with activities
- Observing vital signs frequently
- Monitor cardiovascular status
- Check and check the operation of the pacemaker,
- Instruct the patient on the importance of the immediate report of any chest discomfort.
- Take note of the significant signs and symptoms of decreased cardiac output. • Intervention "Management of the definitive pacemaker" with activities of <!-- -->
- Education on the potential risks of metabolic alterations (eg potential to increase the thresholds of rhythm or capture);
- The importance of attending their periodic checks;
- Sources of higher electromagnetic interference (eg arc welding equipment, radio transmitters, electronic muscle stimulators, concert loudspeakers, electric drills, hand-held metal detectors, magnetic resonance, radiotherapy).
- Keep about 15 cm away from cell phones;
- Signs and symptoms of a dysfunctional pacemaker (eg bradycardia, dizziness, weakness, fatigue, chest discomfort, angina, dyspnea, orthopnea, edema, paroxysmal nocturnal dyspnea, exertional dyspnea, hypotension, syncope, cardiac arrest)
- The importance of carrying the identification card of the manufacturer at all times.
- Information to the patient and the family related to the implantation of the pacemaker (eg, indications, functions, universal programming codes, potential complications); related to the effects of pacemaker treatment to reduce patient uncertainty, fear and anxiety about symptoms (eg dizziness, palpitations, chest pain, shortness of breath) related to treatment (arm edema or augmentation) of heat);
- Teach the patient to check the manufacturer's warnings when in doubt about electrical appliances.
- Fourth stage of the nursing process execution of nursing interventions (NIC) obtained through the expected results (NOC).
To evaluate the response of patients to nursing interventions in their quality of life, the following will be done:
- 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.
- 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.
- Ability of the person to identify their health status.
- Ability of the person to identify their nutritional needs.
- Identify the excretory function (intestinal, urinary and skin).
- Realization of the activities and exercise carried out by the person.
- Conciliar sleep activity
- Sensory alterations: Hearing, gustatory, tactile and olfactory views as well as the presence of pain.
- Form in which the patient feels, feelings, knowledge of himself.
- Way to live with others.
- It is experienced or expressed in the form of thoughts, fantasies, desires, beliefs, attitudes, values, activities, practices, roles and relationships.
- Way to handle stress.
- Values, beliefs that guide the decisions and choices of the individual.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Control group and intervention group, were selected randomly from consecutive cases and standard management
| Arm | Type | Receives |
|---|---|---|
| INSTRUMENT SF 36 | Experimental | Other: Educational, Other: Maneuver controlInstrument 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. |
| Checklist | Active comparator | Other: Educational, Other: Maneuver controlVerify that the interventions of both groups were carried out |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over 60 years old
- Any gender
- That require the placement of a definitive pacemaker either by endocardial or epicardial route and do not present any complication during its installation and hospital stay.
- Signature of informed consent in writing of acceptance to enter the study
Key exclusion criteria (6 listed)
- Older adults with neurological problems.
- Patients with other aggregate pathologies different from atrio-ventricular conduction abnormalities such as valvular diseases, myocardial infarction, congenital diseases, postoperative atrio-ventricular blocks, neoplastic diseases, end-stage renal disease.
- Generator depletion.
- Endocarditis.
- Chronic degenerative diseases whose life expectancy is less than 2 years.
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 |
|---|---|---|
| EducationalTraditional 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 | Checklist, INSTRUMENT SF 36 |
| Maneuver controlVerify that the control and intervention group developed the assigned activities in each case. | Other | Checklist, INSTRUMENT SF 36 |
Primary outcome
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.
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 27 Jun 2019.
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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.
SONIA GONZALEZ MEJORADA principal investigator
Instituto Mexicano del Seguro Social
Questions about this trial
What is this clinical trial studying?
A study testing Educational in people with Quality of Life, run by Instituto Mexicano del Seguro Social.
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 6 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: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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). 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 27 Jun 2019.