Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05995977
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-16
First Post:
2023-08-03
Brief Title:
The Effect of Nursing Interventions Based on Conservation Motivation Theory on Drug Adherence and Healthy Lifestyle Behaviors in Patients With Hypertension A Randomized Controlled Study
Sponsor:
Necmettin Erbakan University
Organization:
Necmettin Erbakan University
Study Overview
Official Title:
The Effect of Nursing Interventions Based on Conservation Motivation Theory on Drug Adherence and Healthy Lifestyle Behaviors in Patients With Hypertension A Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPERNİ
Brief Summary:
Although hypertension is an important cause of premature death it can increase the risk of heart brain kidney and other diseases Worldwide 1 in 4 men and 1 in 5 women over a billion people have this condition httpswwwwhointhealth-topicshypertensiontabtab_1 4 July 2022 The prevalence of hypertension in Turkey was determined as 323 in women 284 in men and 303 in general according to the Turkish Hypertension Prevalence PatenT2 study Sengul et al 2016 Although the exact cause of hypertension is not clear age family history eating habits smoking-alcohol intake weight and physical activity level have a strong influence on blood pressure Hypertension management is normally easy through regular use of antihypertensive drugs and adherence to lifestyle interventions httpsworld-heart-federationorgwhat-we-dohypertension 4 July 2022 As a matter of fact it is stated in the World Health Organization WHO hypertension guideline that healthy lifestyle behaviors should be considered together with antihypertensive drugs WHO 2021 The recommended healthy lifestyle behaviors for the prevention and control of hypertension are reducing salt consumption high potassium intake healthy diet fighting obesity regular physical activity and reducing cigarette-alcohol consumption Mills et al 2020
Despite the availability and high prevalence of treatment for hypertension less than 1 in 5 people worldwide have it under control httpswwwwhointnews-roomfact-sheetsdetailhypertension 4 July 2022 In Turkey an estimated 491 of adults with hypertension are unaware that they have this condition However less than half 462 of adults with hypertension are treated and approximately 1 in 5 adults 239 have it under controlhttpswwwwhointpublicationsmitemhypertension-tur-country-profile-turkey-2020 4 July 2022 Although the nutritional behavioral and environmental causes of hypertension are well established little is known about what actions and interventions are responsible for the low rates of awareness treatment and control Zhou et al 2021
Therefore the development of new approaches to improve the prevention management and control of hypertension has come to the foreÖzpulat 2017 Karmakar et al 2018 The Turkish Hypertension Consensus report recommended that tele-medicine applications should be started to be used for blood pressure control and drug compliance with the advancing technology httpsfkagovtrkalkinma-planlari-detayi-1564726568912 17 August 2022 Hypertension management guideline published by the Japanese Hypertension Society JSH-2019 explains that digital hypertension management can be facilitated using health information technology Kario 2019 According to the International Council of Nurses ICN team-based care especially virtual care empowered through technology can respond to the change sought in healthcare delivery ICN 2021 Likewise WHO stated that using mobile health technologies creates important opportunities to reduce premature deaths from non-communicable diseases WHO 2018 Mobile health technology mainly focuses on the use of mass media such as mobile phone-based or connected interventions Gandapur et al 2016 Karmakar et al 2018 The near ubiquity mobility and direct and instantaneous nature of mobile phones and other mobile devices have enormous potential to impact healthcare delivery and health outcomes White et al 2016 Morawski et al 2017 Gong et al 2020 In the meta-analysis it was seen that mobile health applications have a beneficial effect in health interventions to create behavior change Iribarren et al 2021 Another meta-analysis showed that messages given in behavior change interventions including reducing salt intake in food increasing physical activity quitting smoking increasing consumption of low-fat diet and fruit and vegetables resulted in a significant reduction in blood pressure in particular Saif-Ur-Rahman et al 2019
In our study the Protection Motivation Theory KMT will be used together with the use of mobile phones in creating behavior change KMT is a common framework describing the use of protective behaviors and can be applied to interventions designed to change behavior Rogers 1983 In this context this study aims to evaluate the effects of nursing interventions including mobile phone use and patient education based on CMT on drug compliance and healthy lifestyle behaviors in hypertensive patients
Despite the availability and high prevalence of treatment for hypertension less than 1 in 5 people worldwide have it under control httpswwwwhointnews-roomfact-sheetsdetailhypertension 4 July 2022 In Turkey an estimated 491 of adults with hypertension are unaware that they have this condition However less than half 462 of adults with hypertension are treated and approximately 1 in 5 adults 239 have it under controlhttpswwwwhointpublicationsmitemhypertension-tur-country-profile-turkey-2020 4 July 2022 Although the nutritional behavioral and environmental causes of hypertension are well established little is known about what actions and interventions are responsible for the low rates of awareness treatment and control Zhou et al 2021
Therefore the development of new approaches to improve the prevention management and control of hypertension has come to the foreÖzpulat 2017 Karmakar et al 2018 The Turkish Hypertension Consensus report recommended that tele-medicine applications should be started to be used for blood pressure control and drug compliance with the advancing technology httpsfkagovtrkalkinma-planlari-detayi-1564726568912 17 August 2022 Hypertension management guideline published by the Japanese Hypertension Society JSH-2019 explains that digital hypertension management can be facilitated using health information technology Kario 2019 According to the International Council of Nurses ICN team-based care especially virtual care empowered through technology can respond to the change sought in healthcare delivery ICN 2021 Likewise WHO stated that using mobile health technologies creates important opportunities to reduce premature deaths from non-communicable diseases WHO 2018 Mobile health technology mainly focuses on the use of mass media such as mobile phone-based or connected interventions Gandapur et al 2016 Karmakar et al 2018 The near ubiquity mobility and direct and instantaneous nature of mobile phones and other mobile devices have enormous potential to impact healthcare delivery and health outcomes White et al 2016 Morawski et al 2017 Gong et al 2020 In the meta-analysis it was seen that mobile health applications have a beneficial effect in health interventions to create behavior change Iribarren et al 2021 Another meta-analysis showed that messages given in behavior change interventions including reducing salt intake in food increasing physical activity quitting smoking increasing consumption of low-fat diet and fruit and vegetables resulted in a significant reduction in blood pressure in particular Saif-Ur-Rahman et al 2019
In our study the Protection Motivation Theory KMT will be used together with the use of mobile phones in creating behavior change KMT is a common framework describing the use of protective behaviors and can be applied to interventions designed to change behavior Rogers 1983 In this context this study aims to evaluate the effects of nursing interventions including mobile phone use and patient education based on CMT on drug compliance and healthy lifestyle behaviors in hypertensive patients
Detailed Description:
In this study which was conducted to determine the effect of nursing interventions based on the Protection Motivation Theory on drug compliance and healthy lifestyle behaviors in patients with hypertension 78 adult participants aged 40 to 59 years were randomized pre-tested using antihypertensive drug treatment compliance and healthy lifestyle behaviors scale and blood pressure measurement A study will be conducted in a test post-test controlled design
The Universe of the ResearchThe research population consists of 407 individuals with primary hypertension between the ages of 40-59 who are registered to the Family Health Center FHC No 7 located in Karaman province in Turkey
Sample of the ResearchIn this study G The sample size was calculated at the 95 confidence level by using the Power-3192 program For the calculation Özpancars 2013 study in which the effect of the training given by the nurse on the adherence to treatment in patients with hypertension was examined was used The number of samples required for this calculation is 005 alpha value for the Mann Whitney U test The minimum sample size was determined as 35 for each group 35 people for the control group 35 people for the experimental group 70 people in total by taking an effect size of 090 and the theoretical power of 95 A large sample was accepted from the calculations and with this considering the data loss during the research process 10 of the calculated sample size will be taken and a total of 78 patients will be studied on 39 experimental and 39 control group patients
Data Collection Technique and ToolsIn collecting the data of the research Exclusion Criteria Form Socio-demographic Information Form Scale of Adherence to Antihypertensive Drug Treatment Healthy Lifestyle Behaviors Scale Blood Pressure Measurement Form Telephone follow-up form and short message service follow-up chart will be used Data will be collected by the researcher by face-to-face interview method
Exclusion Criteria FormThis form was created according to the exclusion and inclusion criteria of the study in order to determine the participants to be included in the study The form consists of a total of 7 questions age education level diagnosis of primary hypertension a second chronic disease being pregnant or breastfeeding using a mobile phone compliance with antihypertensive medication and 1 decision to be included in the study
Socio-demographic Information FormThis form was created by researchers as a result of literature review Hacıhasanoğlu et al 2012 Ercil et al 2018 Deniz Akan et al 2020 Ministry of Health 2021 The form consists of 20 questions in total 9 which determine the socio-demographic characteristics of individuals age weight height gender marital status education status employment status monthly income lifestyle and related to hypertension time of diagnosis of hypertension number of anti-hypertensive drugs used daily anti-hypertensive drugs used daily duration of hypertensive drug use regular use of hypertension drugmedication place of follow-up treatment family history of hypertension special diet for hypertension daily teacoffee consumption smoking status alcohol use regular exercise 11 questions It consists of a total of 20 questions
Scale of Adherence to Antihypertensive Drug TreatmentThe Turkish validity and reliability of the scale developed by Morisky Green and Levine were made by Demirezen and Nahcivan Demirezen and Nahcivan 2006 There are a total of 9 statements in the scale that define drug-taking behavior In the first 8 questions answers are answered as Yes and No and yes answers are coded as 1 and no answers as 0 In the ninth question there are 1 neverrarely 2 sometimes 3 sometimes 4 usually 5 always and only one option is selected The Cronbachs alpha coefficient of the scale was reported as 082 in the whole scale The total score of the scale varies between 1-13 In the aforementioned study the definitions of compatible and incompatible with antihypertensive drug treatment were determined according to the 80 cut-off point Accordingly individuals who scored 1-7 according to the total scale score were defined as compatible with the treatment while participants who scored 8 and above were defined as non-adherent to the treatment Deniz Akan et al 2020 the Cronbach alpha coefficient of the scale was found to be 085
Healthy Lifestyle Behaviors ScaleHealthy behaviors were collected with the Healthy Lifestyle Behaviors Scale Scale Walker et al 1987 and revised again in 1996 Walker and Hill-Polerecky 1996 The scale measures health-promoting behaviors associated with an individuals healthy lifestyle The scale consists of 52 items in total and has 6 sub-factors Subgroups are spiritual growth health responsibility physical activity nutrition interpersonal relationships and stress management The overall score of the scale gives the healthy lifestyle behaviors score The lowest score for the whole scale is 52 and the highest score is 208 All items of the scale are positive The rating is in the form of a 4-point likert Never 1 sometimes 2 often 3 regularly 4 The Cronbach Alpha coefficient of the original scale is 094 and the Cronbach Alpha values of the sub-dimensions of the scale vary between 079 and 087 The scale was adapted into Turkish by Bahar et al 2008 In this study the Cronbach alpha reliability coefficient was 092 and the reliability coefficients of the sub-dimensions of the scale were Health responsibility 077 Physical Activity 079 Nutrition 068 Spiritual Development 079 Interpersonal Relations 080 Stress Management 064
Blood Pressure Measurement FormBlood pressure will be measured by the researcher with a calibrated mercury-manual sphygmomanometer Erka Perfect AneroidGermany and stethoscope Blood pressure values were evaluated according to the information in the Turkish Hypertension Consensus Report Aydoğdu et al 2019 and blood pressure values lower than 12080 mmHg were defined as well-managed and individuals with values above that mismanaged The stages followed in blood pressure measurement according to the Directive on Family Medicine Screening and Follow-up Coefficient the Turkish Hypertension Consensus Report and the Office Blood Pressure Measurement criteria specified in the American Heart Association are listed below
Step 1 The patient should rest quietly and comfortably for 5 minutes with his feet flat on the floor and remove the clothes from the arm to be measured
Step 2 Supporting the patients arm at the level of the right atrium and placing the cuff on the bare arm
Step 3 Palpating the radial artery and inflating the cuff 20-30 mmHg after the loss of the pulse then relaxing the cuff pressure to 2 mmHg per second and listening for the Korotkoff sounds
Step 4 Determining the first heard sound Korotkoff 1 as systolic blood pressure and the last Korotkoff sound as diastolic blood pressure
Step 5 Take two measurements 1-2 minutes apart and take the average of the two readings 6th step Oral and written presentation of systolic blood pressure and diastolic blood pressure values to the patient Data CollectionThe data will be collected by the researcher by face-to-face interview after obtaining the informed consent of the patient at the FHC No 7 affiliated to the Karaman Provincial Health Directorate in Turkey
Personal Information FormPre-tests before work Scale of Adherence to Antihypertensive Drug TreatmentPre-tests before work End of intervention Final and Follow-up test at the end of 6th month Healthy Lifestyle Behaviors ScalePre-tests before work End of intervention Final and Follow-up test at the end of 6th month blood pressure measurementPre-tests before work End of intervention Final and Follow-up test at the end of 6th month Variables of the StudyDependent variables Antihypertensive medication adherence scale mean score healthy lifestyle behavior scale mean score systolic and diastolic blood pressure
Independent variables Nursing interventions based on the Protection Motivation Theory Statistical Evaluation of DataIn the statistical evaluation of the data number percentage mean and standard deviation values will be calculated for descriptive statistics In order to compare the variables with each other t-test and analysis of variance will be used in independent groups in cases where the dependent variable is normally distributed and Mann Whitney U test and Kruskal Wallis test in cases where it does not show normal distribution In comparison of dependent groups t test mITT ITT effect size d confidence interval calculations will be made in dependent groups In statistical analyzes the confidence level will be 95 and the power level 1-β will be 95
RandomizationThe socio-demographic data obtained from FHC No 7 where the research will be conducted showed that hypertensive individuals were similar in terms of control variables age gender educational status and income level For this reason stratification will not be used in our study while determining the sample of the research In the first stage hypertensive individuals with a score of 8 and above defined as non-adherent to treatment will be determined by using the scale of adherence to antihypertensive drug therapy This process will continue until the determined sample number is reached In the second stage a list will be created after the participants are reached Hypertensive individuals will be numbered in the created list Afterwards participants will be placed in intervention and control groups online at wwwrandomorg The flow chart of the control and intervention groups has been prepared in accordance with the directive specified in CONSORT 2022 CONSORT Harms 2022 statement explanation and elaboration updated guideline for the reporting of harms in randomised trials bmjcom Accessed June 7 2023
MaskingIt is essential that those conducting the randomized controlled experimental study and the participants do not know who is in the control group and who is in the initiative during the assignment process until the study starts Akın and Koçoğlu 2017 In this study random selection and assignment will be made by a person other than the researcher and a blind technique will be applied by hiding who is in the control and intervention groups from the researcher until the nursing interventions based on CMT are started Thus selection bias in the study will be controlled In this study the researcher will not be blinded during the intervention Patients will not be blinded as consent will be obtained for the application to be made to them Since the purpose of the nursing profession is to produce practice-related information in the real world beyond the boundaries of the laboratory it is stated that the operational approach will more accurately reflect the nursing practice but blinding in pragmatic experiments may be difficult ethical practical etc and blinding those who perform the data analysis Akın and Koçoğlu 2017 For this purpose in order to prevent bias in the evaluation of data Statistical analyzes of the data encoded in the prepared database will be carried out by a statistics expert independently of the researcher The coding for the control and intervention groups will be explained after the statistical analyzes of the study and the tables suitable for the results are made and the research report is written Thus blinding can be made in terms of statistics specialist and reporting After randomization Intention to treat analysis ITT will be applied to prevent reduction bias due to lack of data in resultoutput measurements during the study process In this way selection deduction statistical and reporting bias will be controlled
The Universe of the ResearchThe research population consists of 407 individuals with primary hypertension between the ages of 40-59 who are registered to the Family Health Center FHC No 7 located in Karaman province in Turkey
Sample of the ResearchIn this study G The sample size was calculated at the 95 confidence level by using the Power-3192 program For the calculation Özpancars 2013 study in which the effect of the training given by the nurse on the adherence to treatment in patients with hypertension was examined was used The number of samples required for this calculation is 005 alpha value for the Mann Whitney U test The minimum sample size was determined as 35 for each group 35 people for the control group 35 people for the experimental group 70 people in total by taking an effect size of 090 and the theoretical power of 95 A large sample was accepted from the calculations and with this considering the data loss during the research process 10 of the calculated sample size will be taken and a total of 78 patients will be studied on 39 experimental and 39 control group patients
Data Collection Technique and ToolsIn collecting the data of the research Exclusion Criteria Form Socio-demographic Information Form Scale of Adherence to Antihypertensive Drug Treatment Healthy Lifestyle Behaviors Scale Blood Pressure Measurement Form Telephone follow-up form and short message service follow-up chart will be used Data will be collected by the researcher by face-to-face interview method
Exclusion Criteria FormThis form was created according to the exclusion and inclusion criteria of the study in order to determine the participants to be included in the study The form consists of a total of 7 questions age education level diagnosis of primary hypertension a second chronic disease being pregnant or breastfeeding using a mobile phone compliance with antihypertensive medication and 1 decision to be included in the study
Socio-demographic Information FormThis form was created by researchers as a result of literature review Hacıhasanoğlu et al 2012 Ercil et al 2018 Deniz Akan et al 2020 Ministry of Health 2021 The form consists of 20 questions in total 9 which determine the socio-demographic characteristics of individuals age weight height gender marital status education status employment status monthly income lifestyle and related to hypertension time of diagnosis of hypertension number of anti-hypertensive drugs used daily anti-hypertensive drugs used daily duration of hypertensive drug use regular use of hypertension drugmedication place of follow-up treatment family history of hypertension special diet for hypertension daily teacoffee consumption smoking status alcohol use regular exercise 11 questions It consists of a total of 20 questions
Scale of Adherence to Antihypertensive Drug TreatmentThe Turkish validity and reliability of the scale developed by Morisky Green and Levine were made by Demirezen and Nahcivan Demirezen and Nahcivan 2006 There are a total of 9 statements in the scale that define drug-taking behavior In the first 8 questions answers are answered as Yes and No and yes answers are coded as 1 and no answers as 0 In the ninth question there are 1 neverrarely 2 sometimes 3 sometimes 4 usually 5 always and only one option is selected The Cronbachs alpha coefficient of the scale was reported as 082 in the whole scale The total score of the scale varies between 1-13 In the aforementioned study the definitions of compatible and incompatible with antihypertensive drug treatment were determined according to the 80 cut-off point Accordingly individuals who scored 1-7 according to the total scale score were defined as compatible with the treatment while participants who scored 8 and above were defined as non-adherent to the treatment Deniz Akan et al 2020 the Cronbach alpha coefficient of the scale was found to be 085
Healthy Lifestyle Behaviors ScaleHealthy behaviors were collected with the Healthy Lifestyle Behaviors Scale Scale Walker et al 1987 and revised again in 1996 Walker and Hill-Polerecky 1996 The scale measures health-promoting behaviors associated with an individuals healthy lifestyle The scale consists of 52 items in total and has 6 sub-factors Subgroups are spiritual growth health responsibility physical activity nutrition interpersonal relationships and stress management The overall score of the scale gives the healthy lifestyle behaviors score The lowest score for the whole scale is 52 and the highest score is 208 All items of the scale are positive The rating is in the form of a 4-point likert Never 1 sometimes 2 often 3 regularly 4 The Cronbach Alpha coefficient of the original scale is 094 and the Cronbach Alpha values of the sub-dimensions of the scale vary between 079 and 087 The scale was adapted into Turkish by Bahar et al 2008 In this study the Cronbach alpha reliability coefficient was 092 and the reliability coefficients of the sub-dimensions of the scale were Health responsibility 077 Physical Activity 079 Nutrition 068 Spiritual Development 079 Interpersonal Relations 080 Stress Management 064
Blood Pressure Measurement FormBlood pressure will be measured by the researcher with a calibrated mercury-manual sphygmomanometer Erka Perfect AneroidGermany and stethoscope Blood pressure values were evaluated according to the information in the Turkish Hypertension Consensus Report Aydoğdu et al 2019 and blood pressure values lower than 12080 mmHg were defined as well-managed and individuals with values above that mismanaged The stages followed in blood pressure measurement according to the Directive on Family Medicine Screening and Follow-up Coefficient the Turkish Hypertension Consensus Report and the Office Blood Pressure Measurement criteria specified in the American Heart Association are listed below
Step 1 The patient should rest quietly and comfortably for 5 minutes with his feet flat on the floor and remove the clothes from the arm to be measured
Step 2 Supporting the patients arm at the level of the right atrium and placing the cuff on the bare arm
Step 3 Palpating the radial artery and inflating the cuff 20-30 mmHg after the loss of the pulse then relaxing the cuff pressure to 2 mmHg per second and listening for the Korotkoff sounds
Step 4 Determining the first heard sound Korotkoff 1 as systolic blood pressure and the last Korotkoff sound as diastolic blood pressure
Step 5 Take two measurements 1-2 minutes apart and take the average of the two readings 6th step Oral and written presentation of systolic blood pressure and diastolic blood pressure values to the patient Data CollectionThe data will be collected by the researcher by face-to-face interview after obtaining the informed consent of the patient at the FHC No 7 affiliated to the Karaman Provincial Health Directorate in Turkey
Personal Information FormPre-tests before work Scale of Adherence to Antihypertensive Drug TreatmentPre-tests before work End of intervention Final and Follow-up test at the end of 6th month Healthy Lifestyle Behaviors ScalePre-tests before work End of intervention Final and Follow-up test at the end of 6th month blood pressure measurementPre-tests before work End of intervention Final and Follow-up test at the end of 6th month Variables of the StudyDependent variables Antihypertensive medication adherence scale mean score healthy lifestyle behavior scale mean score systolic and diastolic blood pressure
Independent variables Nursing interventions based on the Protection Motivation Theory Statistical Evaluation of DataIn the statistical evaluation of the data number percentage mean and standard deviation values will be calculated for descriptive statistics In order to compare the variables with each other t-test and analysis of variance will be used in independent groups in cases where the dependent variable is normally distributed and Mann Whitney U test and Kruskal Wallis test in cases where it does not show normal distribution In comparison of dependent groups t test mITT ITT effect size d confidence interval calculations will be made in dependent groups In statistical analyzes the confidence level will be 95 and the power level 1-β will be 95
RandomizationThe socio-demographic data obtained from FHC No 7 where the research will be conducted showed that hypertensive individuals were similar in terms of control variables age gender educational status and income level For this reason stratification will not be used in our study while determining the sample of the research In the first stage hypertensive individuals with a score of 8 and above defined as non-adherent to treatment will be determined by using the scale of adherence to antihypertensive drug therapy This process will continue until the determined sample number is reached In the second stage a list will be created after the participants are reached Hypertensive individuals will be numbered in the created list Afterwards participants will be placed in intervention and control groups online at wwwrandomorg The flow chart of the control and intervention groups has been prepared in accordance with the directive specified in CONSORT 2022 CONSORT Harms 2022 statement explanation and elaboration updated guideline for the reporting of harms in randomised trials bmjcom Accessed June 7 2023
MaskingIt is essential that those conducting the randomized controlled experimental study and the participants do not know who is in the control group and who is in the initiative during the assignment process until the study starts Akın and Koçoğlu 2017 In this study random selection and assignment will be made by a person other than the researcher and a blind technique will be applied by hiding who is in the control and intervention groups from the researcher until the nursing interventions based on CMT are started Thus selection bias in the study will be controlled In this study the researcher will not be blinded during the intervention Patients will not be blinded as consent will be obtained for the application to be made to them Since the purpose of the nursing profession is to produce practice-related information in the real world beyond the boundaries of the laboratory it is stated that the operational approach will more accurately reflect the nursing practice but blinding in pragmatic experiments may be difficult ethical practical etc and blinding those who perform the data analysis Akın and Koçoğlu 2017 For this purpose in order to prevent bias in the evaluation of data Statistical analyzes of the data encoded in the prepared database will be carried out by a statistics expert independently of the researcher The coding for the control and intervention groups will be explained after the statistical analyzes of the study and the tables suitable for the results are made and the research report is written Thus blinding can be made in terms of statistics specialist and reporting After randomization Intention to treat analysis ITT will be applied to prevent reduction bias due to lack of data in resultoutput measurements during the study process In this way selection deduction statistical and reporting bias will be controlled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None