The Patients' Disease Management and Self-management Levels

NCT05341973 | Unknown

• 1 other identifier: B.30.2.ATA.0.01.00/55
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research; The aim of this study is to examine the effects of self-management support given for hypertension patients on patients' adherence to treatment and disease, self-efficacy level, self-care management. This research is a randomized controlled and pretest-posttest applied design. The research will be carried out in Van Yüzüncü Yıl University Research Hospital with patients previously diagnosed with hypertension. The population of the research will consist of patients who have previously applied to the hospital where the research will be conducted and who have been diagnosed with hypertension who meet the research criteria. After the power analysis, it is planned to include 150 hypertension patients in the sample of the study. All patients in the intervention and control groups who meet the inclusion criteria will be verbally informed about the purpose of the study and the method of application, and their consent will be obtained. The pretest forms required for the research will be filled in by face-to-face interview method for all patients. In the study, the number of individuals in the randomization group will be determined by using the computer program, provided that they are equal in number. All materials prepared for self-management support will be delivered to the patients in the intervention group and they will be taught how to use them by the demonstration method. Patients will be asked to do the same procedure and the process will continue until they ensure correct use. Participants will be informed that there is a phone number that they can call whenever they want, when there are subjects that are not understood or that need to be repeated. Patients will be called three times a week and necessary checks will be made on blood pressure monitoring, nutrition, weight control, etc. In this way, patients in the intervention group will be followed remotely by tele-nursing for 3 months, their questions will be answered when they encounter problems, and guidance will be given in case of emergency. No intervention will be made in the control group. Necessary forms will be re-administered to all patients in both groups after 3 months as a post-test. At the end of the research, a comparison of the intervention and control groups will be made.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Self-Care Management Scale in Chronic Diseases (KHÖBYÖ)

  he scale consists of 35 items and is in a five-point Likert type (1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, 5 = strongly agree). Self- protection (items 2, 6, 8, 11, 15, 18, 19, 20, 22, 23, 25-34), and social protection (1, 3, 4, 5, 7, 9, 10, 12) There are two sub-dimensions (items 13, 14, 16, 17, 21, 24 and 35). Items 3, 15, 19 and 28 in the scale are negative statements. The total scores that can be obtained from the scale vary between 35-175 points, and an increase in the score indicates that the individual's self-care management also increases.

  3months

• The 6-item Self-Efficacy for Managing Chronic Diseases Scale(SEMCD6)

  It is an easy-to-use and effective tool for assessing the self-efficacy levels of patients with chronic diseases. The scale is rated on a 10-point scale ranging from "not at all sure" to "very sure". The score obtained from the scale is the average of 6 items, and high scores indicate high self-efficacy. If more than 1 answer is given to an item and the items are consecutive, the low score is included in the calculation. If the 2 answers given are not consecutive, this item is excluded from the calculation. In order for the scale to be calculated, at least 4 items must be answered.

  3months

Study Arms (2)

Education

EXPERIMENTAL

The Self- Management Program Developed will increase Self-Efficacy, Self-Care Management in Hypertension Patients.

Behavioral: Education

Control

NO INTERVENTION

It will not change the Self-Efficacy, Self-Care Management in Hypertension Patients of the Self-Management Program.

Interventions

Education BEHAVIORAL

Self-Management Program will increase Self-Efficacy, Self-Care Management in Hypertension Patients.

Education

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Follow-up for at least 6 months with the diagnosis of essential hypertension,
• Using antihypertensive drugs,
• No change in antihypertensive drug treatment in the last 1 month,
• Not having any other accompanying chronic disease (Diabetes mellitus, cancer, chronic -kidney failure, chronic obstructive pulmonary disease, heart failure, etc.),
• Having no mental or communication problems,
• Computer/tablet/smartphone etc. to watch videos. having technological tools,
• Having internet,
• Being over 18 years old,
• Having at least primary education level, Not being pregnant or lactating,

You may not qualify if:

• Follow-up for less than 6 months with the diagnosis of essential hypertension,
• Not using antihypertensive drugs,
• Changes in antihypertensive drug therapy in the last 1 month,
• Presence of another concomitant chronic disease (Diabetes mellitus, cancer, chronic -kidney failure, chronic obstructive pulmonary disease, heart failure, etc.),
• Having a mental or communication problem,
• Computer/tablet/smartphone etc. to watch videos. lack of technological tools,
• Lack of internet,

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

BAHAR Çiftçi

Erzurum, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• BAHAR Çiftçi

  Ataturk University

  STUDY DIRECTOR

Central Study Contacts

BAHAR Çiftçi

CONTACT

05068517857; bahar.ciftci@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 22, 2022
• Study Start: March 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

TU (1)