HypertensionNCT05221424
Roy Adaptation Model in Hypertensive Patients
A study testing Patient Education in people with Hypertension and Patient Engagement, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of training given according to the Roy Adaptation Model on medical treatment and physiological, psychological and social adaptation to the disease in individuals with hypertension. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Patient Engagement, Nurse-Patient Relations
- What is being tested?
- Patient Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2018to 27 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being diagnosed with hypertension for at least 6 months
- being 18 years old and over
- not having any communication problem
- having no mental confusion or other psychiatric problems
- being literate in Turkish and knowing how to speak Turkish
- being voluntary to participate in the study.
Who cannot join
- being under 18 years of age
- having cognitive problems
- not wanting to participate in the study
- participating in a similar training program before
- deciding to withdraw the study
- being unable to complete the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of The Effect of Training Given According to Roy Adaptation Model On Adaptation to The Disease in Patients With Hypertension
The aim of this study was to determine the effect of training given according to the Roy Adaptation Model on medical treatment and physiological, psychological and social adaptation to the disease in individuals with hypertension.
Read the detailed description
Despite effective and available antihypertensive drugs, the studies showed that less than half of patients with hypertension received antihypertensive therapy and only 1 out of 3 people (less than 20%) had blood pressure control. One of the most important factors in controlling blood pressure in patients with hypertension is the patients' adherence to treatment. Non-adherence to treatment in chronic diseases is considered as a public health problem that increases mortality rates and the economic burden of the disease.
In order to prevent and control hypertension, the importance of non-medical strategies, including lifestyle changes is also emphasized. Lifestyle changes have an important role in increasing treatment and controlling symptoms in hypertensive patients and it is recommended as the first step in managing blood pressure. The most important reason for the failure in the management of hypertension is the patient profile which does not carry out lifestyle changes in parallel with treatment. In this type of patient profile, problems are experienced in the patient's adherence to treatment and it becomes difficult to control blood pressure. Good adaptation to lifestyle changes can reduce the medication needs, lead to a positive effect on cardiovascular risk factors and play an important role for the patient to provide contribution to his/her own treatment.
The non-adherence of hypertensive patients is quite common during their lifestyle changes depending on the disease and during the medication use. Some of the patients stop taking their medications and some do not use their medication regularly. Increasing adherence is the most important factor in success. One of the best ways to increase adherence is to involve the patient in decisions about treatment strategies. One of the factors affecting the adherence to treatment in hypertensive patients is the lack of information about the disease and treatment. For this reason, it is important to increase the awareness and knowledge of patients about the risks associated with blood pressure control in particular. It is possible for hypertensive patients to have knowledge about the disease and treatment, comply with the lifestyle changes and thus control the blood pressure through the training given to the patient. The training and monitoring programs applied for hypertensive patients are one of the best practices that enables the patient to adapt to the disease, control blood pressure and respond to medical treatment faster and live with the disease.
In order for hypertensive patients to comply with the treatment and to implement lifestyle changes, nurses, who are the closest healthcare professionals, have important responsibilities and duties. In the studies, it has been revealed that the interventions applied under the supervision of nurses increase medication adherence. The nursing models, which act as a guide in professional nursing practices and are used in professional development, patient care, and patient training, provide great convenience and assistance in the holistic assessment of the patient. By using models, the problems in the application can be identified by determining the basic concepts of care and the correlation between the concepts and training can be given within this framework by developing solutions for these problems.
In recent years, the use of nursing models in the researches and the patient care management draws a lot of interest in Turkey. One of the models used commonly in the profession is the Roy Adaptation Model (RAM). The purpose of RAM is to provide adaptation for a person to his/her environmental stimuli through adaptive shape methods. According to RAM, individuals should provide and develop their physical and psychological adaptations. This model identifies the reasons of non-adherence to disease and treatment (main and background causes, other stimuli) through an accurate investigation of different individual aspects (for example: physiological aspects, self-perception, role-playing and independence). Thus, it is stated to be helpful in designing a comprehensive training program in order to develop healthy behaviors and comply with the lifestyle changes. Some studies in Turkey showed that the use of RAM increased the adaptation in patients with essential hypertension, increased medication adherence in patients who were followed up with diagnosis of ruptured ectopic pregnancies, and provided positive effects on the diabetes care profile in diabetic individuals. Only one study was found that did not publish when this study was planned, but was seen to be published recently, and evaluating the training given to hypertensive patients using RAM on hypertension management and medical adherence. However, the literature review performed in different databases revealed that there was no study evaluating the effects of training given according to RAM on the disease and psychosocial adjustment in patients with hypertension. For this reason, we assumed that training given by using RAM could cause adherence to medical treatment and disease in the experimental group compared to the control group.
The aim of this study is to evaluate the effects of training given according to Roy Adaptation Model on the disease and psychosocial adjustment in patients with hypertension.
- Conditions
- Hypertension, Patient Engagement, Nurse-Patient Relations
- Being tested
- Patient Education
- Keywords
- Roy adaptation model, patient training, adaptation, hypertension, nursing
- Medical subject headings
- Hypertension, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationOther
The training program about hypertension prepared according to the Roy Adaptation Model was performed in a room in the cardiology outpatient clinic of a state hospital. The training content was shaped according to 4 (four) basic areas of the Roy Adaptation Model (physiological field, self-concept field, role function field and interdependence field). The training taught to each patient individually and interactively with the support of powerpoint presentation lasted for averagely 45-50 minutes. A "Hypertension Training Booklet" was prepared according to the Roy Adaptation Model in order to be used during the training and to strengthen the training.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Experimental | MARS, PAIS-SR and Patient Information Form, containing data about the patient and the disease were applied to each patient in the experimental group during pretest. Then, the individual training was given to each patient by giving the "Hypertension Training Booklet" prepared in line with the Roy Adaptation Model. The training period lasted for averagely 45-50 minutes for each patient. After the training, the patients were called by phone at least once a week, every week for four weeks and reminder information was obtained and their follow-ups were made. One month after the training, post-test data were applied to the patients. In the posttest phase; MARS, PAIS-SR and the questions containing lifestyle changes were repeated and their follow-ups were then terminated. Receives: Other: Patient Education |
| No Intervention | No intervention | • MARS, PAIS-SR and Patient Information Form containing data about the patient and the disease were applied to each patient in the control group in the pretest. Without giving any training to the patients in the control group, only the patients were called at least once a week, every week for four weeks and their health status was examined. One month after the collection of initial data, posttest data were applied to the patients. In the posttest phase; MARS, PAIS-SR and the questions containing lifestyle changes were repeated and then their follow-ups were terminated. After the follow-up, the training prepared in line with Roy Adaptation Model was applied to the voluntary patients and the training booklet was given to them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Rating Scale (MARS)
In the scale, there are a total of 10 questions that can be answered as yes or no. Negative answers are calculated as 0 point while positive answers are calculated as 1 point. These questions evaluate the patients' adherence to and attitude towards the treatment within the last week. Low score indicates poor adherence to the treatment while high scores indicates high adherence to the treatment.
Measured: 4 weeks after
Psychosocial Adjustment to Illness-Self-Report Scale (PAIS-SR)
The scale contains 46 questions in 7 psychosocial adjustment fields. Psychosocial adjustment fields are "Health Care Orientation" (Part 1), "Vocational Environment" (Part 2), "Domestic Environment" (Part 3), "Sexual Relationships" (Part 4), "Extended Family Relationships" (Part 5), "Social Environment" (Part 6) and "Psychological Distress" (Part 7). The positive statement given to the question is scored with "0" point while negative statement is scored with "3" points. The lowest and highest scores of the scale are 0 and 138 points. In the scale, scores below 35 indicate "good psychosocial adjustment", scores between 35-51 points indicate "moderate psychosocial adjustment", scores above 51 indicate "poor psychosocial adjustment"
Measured: 4 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start7 Jan 2018
- Primary completion14 Apr 2018
- Study completion27 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted as a single-blind randomized controlled study with pretest-posttest
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihat Demirel, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221424
- Sponsor's protocol ID
- 206195
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effect of Training Given According to Roy Adaptation Model On Adaptation to The Disease in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT05221424
- Acronym / sponsor ID
- 206195
- Conditions
- Hypertension, Patient Engagement, Nurse-Patient Relations
- Keywords
- Roy adaptation model, patient training, adaptation, hypertension, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 14 Apr 2018 (actual)
- Study completion
- 27 May 2018 (actual)
- First posted
- 3 Feb 2022 (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 aim of this study was to determine the effect of training given according to the Roy Adaptation Model on medical treatment and physiological, psychological and social adaptation to the disease in individuals with hypertension.
Detailed description
Despite effective and available antihypertensive drugs, the studies showed that less than half of patients with hypertension received antihypertensive therapy and only 1 out of 3 people (less than 20%) had blood pressure control. One of the most important factors in controlling blood pressure in patients with hypertension is the patients' adherence to treatment. Non-adherence to treatment in chronic diseases is considered as a public health problem that increases mortality rates and the economic burden of the disease.
In order to prevent and control hypertension, the importance of non-medical strategies, including lifestyle changes is also emphasized. Lifestyle changes have an important role in increasing treatment and controlling symptoms in hypertensive patients and it is recommended as the first step in managing blood pressure. The most important reason for the failure in the management of hypertension is the patient profile which does not carry out lifestyle changes in parallel with treatment. In this type of patient profile, problems are experienced in the patient's adherence to treatment and it becomes difficult to control blood pressure. Good adaptation to lifestyle changes can reduce the medication needs, lead to a positive effect on cardiovascular risk factors and play an important role for the patient to provide contribution to his/her own treatment.
The non-adherence of hypertensive patients is quite common during their lifestyle changes depending on the disease and during the medication use. Some of the patients stop taking their medications and some do not use their medication regularly. Increasing adherence is the most important factor in success. One of the best ways to increase adherence is to involve the patient in decisions about treatment strategies. One of the factors affecting the adherence to treatment in hypertensive patients is the lack of information about the disease and treatment. For this reason, it is important to increase the awareness and knowledge of patients about the risks associated with blood pressure control in particular. It is possible for hypertensive patients to have knowledge about the disease and treatment, comply with the lifestyle changes and thus control the blood pressure through the training given to the patient. The training and monitoring programs applied for hypertensive patients are one of the best practices that enables the patient to adapt to the disease, control blood pressure and respond to medical treatment faster and live with the disease.
In order for hypertensive patients to comply with the treatment and to implement lifestyle changes, nurses, who are the closest healthcare professionals, have important responsibilities and duties. In the studies, it has been revealed that the interventions applied under the supervision of nurses increase medication adherence. The nursing models, which act as a guide in professional nursing practices and are used in professional development, patient care, and patient training, provide great convenience and assistance in the holistic assessment of the patient. By using models, the problems in the application can be identified by determining the basic concepts of care and the correlation between the concepts and training can be given within this framework by developing solutions for these problems.
In recent years, the use of nursing models in the researches and the patient care management draws a lot of interest in Turkey. One of the models used commonly in the profession is the Roy Adaptation Model (RAM). The purpose of RAM is to provide adaptation for a person to his/her environmental stimuli through adaptive shape methods. According to RAM, individuals should provide and develop their physical and psychological adaptations. This model identifies the reasons of non-adherence to disease and treatment (main and background causes, other stimuli) through an accurate investigation of different individual aspects (for example: physiological aspects, self-perception, role-playing and independence). Thus, it is stated to be helpful in designing a comprehensive training program in order to develop healthy behaviors and comply with the lifestyle changes. Some studies in Turkey showed that the use of RAM increased the adaptation in patients with essential hypertension, increased medication adherence in patients who were followed up with diagnosis of ruptured ectopic pregnancies, and provided positive effects on the diabetes care profile in diabetic individuals. Only one study was found that did not publish when this study was planned, but was seen to be published recently, and evaluating the training given to hypertensive patients using RAM on hypertension management and medical adherence. However, the literature review performed in different databases revealed that there was no study evaluating the effects of training given according to RAM on the disease and psychosocial adjustment in patients with hypertension. For this reason, we assumed that training given by using RAM could cause adherence to medical treatment and disease in the experimental group compared to the control group.
The aim of this study is to evaluate the effects of training given according to Roy Adaptation Model on the disease and psychosocial adjustment in patients with hypertension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was conducted as a single-blind randomized controlled study with pretest-posttest
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Experimental | Other: Patient EducationMARS, PAIS-SR and Patient Information Form, containing data about the patient and the disease were applied to each patient in the experimental group during pretest. Then, the individual training was given to each patient by giving the "Hypertension Training Booklet" prepared in line with the Roy Adaptation Model. The training period lasted for averagely 45-50 minutes for each patient. After the training, the patients were called by phone at least once a week, every week for four weeks and reminder information was obtained and their follow-ups were made. One month after the training, post-test data were applied to the patients. In the posttest phase; MARS, PAIS-SR and the questions containing lifestyle changes were repeated and their follow-ups were then terminated. |
| No Intervention | No intervention | –• MARS, PAIS-SR and Patient Information Form containing data about the patient and the disease were applied to each patient in the control group in the pretest. Without giving any training to the patients in the control group, only the patients were called at least once a week, every week for four weeks and their health status was examined. One month after the collection of initial data, posttest data were applied to the patients. In the posttest phase; MARS, PAIS-SR and the questions containing lifestyle changes were repeated and then their follow-ups were terminated. After the follow-up, the training prepared in line with Roy Adaptation Model was applied to the voluntary patients and the training booklet was given to them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being diagnosed with hypertension for at least 6 months
- being 18 years old and over
- not having any communication problem
- having no mental confusion or other psychiatric problems
- being literate in Turkish and knowing how to speak Turkish
Key exclusion criteria (6 listed)
- being under 18 years of age
- having cognitive problems
- not wanting to participate in the study
- participating in a similar training program before
- deciding to withdraw the study
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 |
|---|---|---|
| Patient EducationThe training program about hypertension prepared according to the Roy Adaptation Model was performed in a room in the cardiology outpatient clinic of a state hospital. The training content was shaped according to 4 (four) basic areas of the Roy Adaptation Model (physiological field, self-concept field, role function field and interdependence field). The training taught to each patient individually and interactively with the support of powerpoint presentation lasted for averagely 45-50 minutes. A "Hypertension Training Booklet" was prepared according to the Roy Adaptation Model in order to be used during the training and to strengthen the training. | Other | Active Comparator |
Primary outcome
Medication Adherence Rating Scale (MARS)
Time frame: 4 weeks after
In the scale, there are a total of 10 questions that can be answered as yes or no. Negative answers are calculated as 0 point while positive answers are calculated as 1 point. These questions evaluate the patients' adherence to and attitude towards the treatment within the last week. Low score indicates poor adherence to the treatment while high scores indicates high adherence to the treatment.
Psychosocial Adjustment to Illness-Self-Report Scale (PAIS-SR)
Time frame: 4 weeks after
The scale contains 46 questions in 7 psychosocial adjustment fields. Psychosocial adjustment fields are "Health Care Orientation" (Part 1), "Vocational Environment" (Part 2), "Domestic Environment" (Part 3), "Sexual Relationships" (Part 4), "Extended Family Relationships" (Part 5), "Social Environment" (Part 6) and "Psychological Distress" (Part 7). The positive statement given to the question is scored with "0" point while negative statement is scored with "3" points. The lowest and highest scores of the scale are 0 and 138 points. In the scale, scores below 35 indicate "good psychosocial adjustment", scores between 35-51 points indicate "moderate psychosocial adjustment", scores above 51 indicate "poor psychosocial adjustment"
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 11 Mar 2022.
- Individual participant dataSharing planned: Yes
Related trials for Hypertension
RecruitingPhase 4
Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients
Pulmonary Arterial Hypertension
Not yet recruiting
Effects of Smartphone Use and Television Viewing on Standardized BP Measurement: The SCREENS-BP Study
Hypertension
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education in people with Hypertension and Patient Engagement, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
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 6 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 11 Mar 2022. 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 Turkey (Türkiye). 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?
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?
Medication Adherence Rating Scale (MARS) (time frame: 4 weeks after). The study lists 2 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 11 Mar 2022.