Effect of a Daily Life Activity-Based Awareness Training Program on Hypertensive Individuals

NCT ID: NCT06547879

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2024-07-05

Brief 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. 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.

Conditions

Hypertension; Cardiovascular Diseases; Self Efficacy; Treatment Adherence and Compliance; Health Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Hypertension Self Management Program

Intervention Type: BEHAVIORAL

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.

Control group

Usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hypertension Self Management Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Hacer Oturmaz

Doctoral Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hacer Eroğlu

Role: PRINCIPAL_INVESTIGATOR

haceroturmaz@hacettepe.edu.tr

Locations

Ornek Mahallesi, 2061. Caddesi 4/1 Blok No:37

Altındağ, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

record 4

Identifier Type: -

Identifier Source: org_study_id