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

NCT06547879 | Completed DMC

• 1 other identifier: record 4
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  At week 0, week 8 and week 12

Secondary Outcomes (3)

• Systolic and diastolic blood pressure

  At week 0, week 8 and week 12

• Metabolic Control Variables

  At week 0 and week 8

• Hypertension Information Assessment

  At week 0 and week 8

Study Arms (2)

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.

Behavioral: Hypertension Self Management Program

Control group

NO INTERVENTION

Usual care.

Interventions

Hypertension Self Management Program 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

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

Altındağ, Ankara, 06080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Vascular Diseases; Behavior

Study Officials

• Hacer Eroğlu

  haceroturmaz@hacettepe.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of Participants: Blinding of participants means that the individuals taking part in the study are not aware of which group they have been assigned to, whether it is the intervention group or the control group. This helps to prevent bias in their behavior and responses, as they do not know if they are receiving the actual treatment or a placebo. Blinding of Outcome Assessors: Blinding of outcome assessors involves keeping the individuals who are measuring and assessing the results of the study unaware of which participants belong to the intervention or control group. This is done to ensure that the data collected and the evaluations made are not influenced by any preconceived notions or expectations about the effectiveness of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Model Details: The study has a parallel two-group, randomized controlled intervention design.

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 9, 2024
• Study Start: March 15, 2023
• Primary Completion: May 15, 2023
• Study Completion: July 5, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)