HypertensionNCT06547879
Effect of a Daily Life Activity-Based Awareness Training Program on Hypertensive Individuals
A study testing Hypertension Self Management Program in people with Hypertension and Cardiovascular Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluated an education program based on the Roper, Logan, and Tierney model of daily living activities, supported by mindfulness, for hypertensive individuals. The intervention group received eight weeks of online sessions, while the control group received routine care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Cardiovascular Diseases, Self Efficacy
- What is being tested?
- Hypertension Self Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 5 Jul 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65
- Literate (able to read and write)
- Followed up for at least 6 months with a diagnosis of stage 1 primary hypertension (HT)
- Taking at least one antihypertensive medication
- No changes in antihypertensive medication in the past month
- Able to use a smartphone and WhatsApp® application
- Having internet access and willing to participate in online sessions
Who cannot join
- Those with hearing and vision problems
- Those with cognitive impairment
- Having a psychiatric diagnosis such as major depression
- Having a history of major heart surgery in the last 6 months
- Those with severe symptom burden due to advanced COPD, heart failure, asthma, cancer
- Individuals who used another mind-body-based approach (yoga, meditation, relaxation exercise, etc.) during the research were not included in the sample.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ornek Mahallesi, 2061. Caddesi 4/1 Blok No:37
Altındağ, Ankara, 06080
About this study
Official title: Effect of an Education Program Based on the Roper, Logan, and Tierney Model of Daily Living Activities Supported With Mindfulness on Self Care, Treatment Adherence, and Healthy Lifestyle Behaviors in Hypertensive Individuals
This randomized controlled study evaluated an education program based on the Roper, Logan, and Tierney model of daily living activities, supported by mindfulness, for hypertensive individuals. The intervention group received eight weeks of online sessions, while the control group received routine care. Results showed significant improvements in systolic and diastolic blood pressure, self-care, treatment adherence, and healthy lifestyle behaviors in the intervention group compared to controls (p<0.05). Findings suggest that mindfulness-supported education enhances hypertension management. Further studies with larger samples and long-term follow-up are recommended.
Read the detailed description
Considering that theory-based educational practices alone are not sufficient in the management of HT and that a multifaceted perspective must be developed, in addition to the education based on the ADL nursing model, the conscious awareness approach, which is effective in stress management with its easy integration into daily life, has also been included in this program. In this way, individuals can gain experience and reach self-awareness as a result of theory and skill-based training and feel more motivated to adopt healthy lifestyle behaviors. Multicomponent interventions offer a more comprehensive approach by combining a variety of methods, such as mindfulness, exercise, and dietary changes, as well as educational programs. Such integrated interventions can positively impact both individuals' knowledge and lifestyle habits, providing more effective results in the management of HT and contributing to long-term health improvements.
In this context, this study aimed to evaluate the effect of the training program, structured according to Roper, Logan and Tierney's ADL nursing model and supported by awareness, on self-care, treatment compliance and healthy lifestyle behaviors in individuals with HT. This research is the first randomized controlled study in which the effects of a training program that is suitable for our country's patient profile for HT self-management, shaped according to multidimensional and up-to-date guidelines, that can encourage participants to change behavior, are tested. It has the potential to provide unique contributions to the field with its potential to create infrastructure.
- Conditions
- Hypertension, Cardiovascular Diseases, Self Efficacy, Treatment Adherence and Compliance, Health Behavior
- Being tested
- Hypertension Self Management Program
- Keywords
- Daily living activities, education, healthy living, hypertension, mindfulness, self-care, treatment adherence
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Treatment Adherence and Compliance, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertension Self Management ProgramBehavioural
The HT self-management training program was continued in the form of one session per week, a total of 8 modules, for 8 weeks, with different module content each week. After these eight-week training and awareness sessions were completed, the implementation of the study was terminated (week 8), no additional intervention was given to the intervention group, and the evaluations at the 8th week (end of intervention-T1) and the 12th week (follow-up-T2) were carried out by the researcher during the routine checks of the participants at the outpatient clinic. It was carried out face to face.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | One session per week; 20 minutes for the training module and 25 minutes for the awareness practice, a total of 45 minutes each week, for a total of 8 weeks. Receives: Behavioral: Hypertension Self Management Program |
| Control group | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension Self-Care Profile
The Hypertension Self-Care Profile Scale has three subscales: behavior, motivation and self-efficacy. In this scale, each sub-dimension is evaluated separately and a total of minimum 20 and maximum 80 points can be obtained from the scale. Higher scores indicate better self-care.
Measured: At week 0, week 8 and week 12
Hill-Bone Hypertension Treatment Compliance Scale
The scale consists of three sub-dimensions (interview, medical and nutrition) and a total of 14 questions. The total score that can be obtained from the scale varies between 14 and 56; A score of 14 indicates full compliance, while higher scores indicate treatment non-compliance.
Measured: At week 0, week 8 and week 12
Healthy Lifestyle Behaviors Scale II
It aims to evaluate individuals' behaviors towards healthy lifestyles. There are 52 items in total in the scale, and all of the items consist of positive expressions. The minimum score that can be obtained from the scale is 52 and the maximum score is 208.
Measured: At week 0, week 8 and week 12
Conscious awareness
It evaluates individual differences in individuals' states of consciousness and measures their tendency to be aware of and pay attention to momentary experiences in daily life. The total score that can be obtained varies between 15 and 90. A high score indicates a high level of conscious awareness.
Measured: At week 0, week 8 and week 12
Secondary outcomes (3)
Systolic and diastolic blood pressure
Blood pressure measurement by the researcher with a digital device.
Measured: At week 0, week 8 and week 12
Metabolic Control Variables
A total of 15 items regarding fasting blood sugar, HbA1c, urea, creatinine, uric acid, glomerular filtration rate, serum sodium and potassium values, lipid panel, hemogram, height, weight and BMI values.
Measured: At week 0 and week 8
Hypertension Information Assessment
Individuals' HT knowledge status before and after the intervention was evaluated and the data were classified as "correct" and "incorrect" and calculated as number-percentage.
Measured: At week 0 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start15 Mar 2023
- Primary completion15 May 2023
- Study completion5 Jul 2024
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study has a parallel two-group, randomized controlled intervention design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Oturmaz, Hacettepe University
- Investigators
- Hacer Eroğlu, Principal investigator, haceroturmaz@hacettepe.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547879
- Sponsor's protocol ID
- record 4
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers interested in accessing the IPD should contact the study's principal investigator via email at \[email address\]. Requests will be reviewed and responded to within four weeks.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Education Program Based on the Roper, Logan, and Tierney Model of Daily Living Activities Supported With Mindfulness on Self Care, Treatment Adherence, and Healthy Lifestyle Behaviors in Hypertensive Individuals
- ClinicalTrials.gov ID
- NCT06547879
- Acronym / sponsor ID
- record 4
- Conditions
- Hypertension, Cardiovascular Diseases, Self Efficacy, Treatment Adherence and Compliance, Health Behavior
- Keywords
- Daily living activities, education, healthy living, hypertension, mindfulness, self-care, treatment adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 9 Aug 2024 (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.
This randomized controlled study evaluated an education program based on the Roper, Logan, and Tierney model of daily living activities, supported by mindfulness, for hypertensive individuals. The intervention group received eight weeks of online sessions, while the control group received routine care. Results showed significant improvements in systolic and diastolic blood pressure, self-care, treatment adherence, and healthy lifestyle behaviors in the intervention group compared to controls (p<0.05). Findings suggest that mindfulness-supported education enhances hypertension management. Further studies with larger samples and long-term follow-up are recommended.
Detailed description
Considering that theory-based educational practices alone are not sufficient in the management of HT and that a multifaceted perspective must be developed, in addition to the education based on the ADL nursing model, the conscious awareness approach, which is effective in stress management with its easy integration into daily life, has also been included in this program. In this way, individuals can gain experience and reach self-awareness as a result of theory and skill-based training and feel more motivated to adopt healthy lifestyle behaviors. Multicomponent interventions offer a more comprehensive approach by combining a variety of methods, such as mindfulness, exercise, and dietary changes, as well as educational programs. Such integrated interventions can positively impact both individuals' knowledge and lifestyle habits, providing more effective results in the management of HT and contributing to long-term health improvements.
In this context, this study aimed to evaluate the effect of the training program, structured according to Roper, Logan and Tierney's ADL nursing model and supported by awareness, on self-care, treatment compliance and healthy lifestyle behaviors in individuals with HT. This research is the first randomized controlled study in which the effects of a training program that is suitable for our country's patient profile for HT self-management, shaped according to multidimensional and up-to-date guidelines, that can encourage participants to change behavior, are tested. It has the potential to provide unique contributions to the field with its potential to create infrastructure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study has a parallel two-group, randomized controlled intervention design.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Hypertension Self Management ProgramOne session per week; 20 minutes for the training module and 25 minutes for the awareness practice, a total of 45 minutes each week, for a total of 8 weeks. |
| Control group | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 18 and 65
- Literate (able to read and write)
- Followed up for at least 6 months with a diagnosis of stage 1 primary hypertension (HT)
- Taking at least one antihypertensive medication
- No changes in antihypertensive medication in the past month
Key exclusion criteria (6 listed)
- Those with hearing and vision problems
- Those with cognitive impairment
- Having a psychiatric diagnosis such as major depression
- Having a history of major heart surgery in the last 6 months
- Those with severe symptom burden due to advanced COPD, heart failure, asthma, cancer
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 |
|---|---|---|
| Hypertension Self Management ProgramThe HT self-management training program was continued in the form of one session per week, a total of 8 modules, for 8 weeks, with different module content each week. After these eight-week training and awareness sessions were completed, the implementation of the study was terminated (week 8), no additional intervention was given to the intervention group, and the evaluations at the 8th week (end of intervention-T1) and the 12th week (follow-up-T2) were carried out by the researcher during the routine checks of the participants at the outpatient clinic. It was carried out face to face. | Behavioural | Intervention group |
Primary outcome
Hypertension Self-Care Profile
Time frame: At week 0, week 8 and week 12
The Hypertension Self-Care Profile Scale has three subscales: behavior, motivation and self-efficacy. In this scale, each sub-dimension is evaluated separately and a total of minimum 20 and maximum 80 points can be obtained from the scale. Higher scores indicate better self-care.
Hill-Bone Hypertension Treatment Compliance Scale
Time frame: At week 0, week 8 and week 12
The scale consists of three sub-dimensions (interview, medical and nutrition) and a total of 14 questions. The total score that can be obtained from the scale varies between 14 and 56; A score of 14 indicates full compliance, while higher scores indicate treatment non-compliance.
Healthy Lifestyle Behaviors Scale II
Time frame: At week 0, week 8 and week 12
It aims to evaluate individuals' behaviors towards healthy lifestyles. There are 52 items in total in the scale, and all of the items consist of positive expressions. The minimum score that can be obtained from the scale is 52 and the maximum score is 208.
Conscious awareness
Time frame: At week 0, week 8 and week 12
It evaluates individual differences in individuals' states of consciousness and measures their tendency to be aware of and pay attention to momentary experiences in daily life. The total score that can be obtained varies between 15 and 90. A high score indicates a high level of conscious awareness.
3 secondary outcomes
Systolic and diastolic blood pressure
Time frame: At week 0, week 8 and week 12
Metabolic Control Variables
Time frame: At week 0 and week 8
Hypertension Information Assessment
Time frame: At week 0 and week 8
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 9 Aug 2024.
- Individual participant dataSharing planned: No. Researchers interested in accessing the IPD should contact the study's principal investigator via email at [email address]. Requests will be reviewed and responded to within four weeks.
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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.
Hacer Eroğlu principal investigator
haceroturmaz@hacettepe.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertension Self Management Program in people with Hypertension and Cardiovascular Diseases, run by Hacettepe 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 7 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 9 Aug 2024. 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?
Hypertension Self-Care Profile (time frame: At week 0, week 8 and week 12). The study lists 4 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 9 Aug 2024.