Roy Adaptation Model in Hypertensive Patients

NCT05221424 | Completed

• 1 other identifier: 206195
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Patient Engagement; Nurse-Patient Relations

Keywords

Roy adaptation model; patient training; adaptation; hypertension; nursing

Outcome Measures

Primary Outcomes (2)

• 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.

  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"

  4 weeks after

Study Arms (2)

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.

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.

Interventions

Patient Education OTHER

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.

Active Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Muş Alparslan University

Muş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension; Patient Participation

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study was conducted as a single-blind randomized controlled study with pretest-posttest

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 3, 2022
• Study Start: January 7, 2018
• Primary Completion: April 14, 2018
• Study Completion: May 27, 2018
• Last Updated: March 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: no time limit
• Access Criteria: All data

Locations

TU (1)