Clinical trial NCT06547879: Effect of a Daily Life Activity-Based Awareness Training Program on Hypertensive Individuals
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has a parallel two-group, randomized controlled intervention design.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Hypertension Self-Care Profile
timeFrame: At week 0, week 8 and week 12
measure: Hill-Bone Hypertension Treatment Compliance Scale
timeFrame: At week 0, week 8 and week 12
measure: Healthy Lifestyle Behaviors Scale II
timeFrame: At week 0, week 8 and week 12
measure: Conscious awareness
timeFrame: At week 0, week 8 and week 12
Secondary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: At week 0, week 8 and week 12
measure: Metabolic Control Variables
timeFrame: At week 0 and week 8
measure: Hypertension Information Assessment
timeFrame: At week 0 and week 8
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Ornek Mahallesi, 2061. Caddesi 4/1 Blok No:37
state: Ankara
Study officials:
affiliation: haceroturmaz@hacettepe.edu.tr
name: Hacer Eroğlu
role: PRINCIPAL_INVESTIGATOR
References: