The Effect of Self-Management Support Provided to Hypertension Patients Affected by the Earthquake Via Tele-Nursing on Patients' Treatment Compliance and Self-Care Management

April 4, 2024 updated by: Gülcan Bahçecioğlu Turan, Firat University

The Effect of Self-Management Support Provided to Hypertension Patients Affected by the Earthquake Via Tele-Nursing on Patients' Treatment Compliance and Self-Care Management: A Randomized Controlled Study

This important research includes a randomized controlled trial evaluating the potential of self-management support provided via telenursing to earthquake-affected hypertension patients to improve patients' treatment adherence and overall self-care management. This study will be carried out at Fırat University Hospital and will cover a wide range of effects on health outcomes in individuals receiving hypertension treatment. The sample selected from hypertension patients, which constitute the population of the research, was based on predetermined power analysis criteria. It has been determined that at least 51 hypertension patients should be included in each of the intervention and control groups, and accordingly, a total of 150 hypertension patients will be included in the study.

. The results obtained within this framework may provide guidance in the development and implementation of Turkey's health policies, and may also shed light on strategies for the management of other similar health problems. On the other hand, strengthening the digital health infrastructure and effective management of chronic diseases, which are among the health-related targets of the Development Plan, further emphasize the importance of this research. The success of the self-management model supported by tele-nursing can serve as an example in the integration of digital health technologies into Turkey's healthcare system and be an important step towards achieving strategic goals in this field.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being followed for at least 6 months with the diagnosis of essential hypertension,

    • Patients diagnosed with hypertension who suffered financial or moral loss after the earthquake
    • Located in Elazığ at the time of the February 6 earthquake
    • Continuing to live in Elazığ after the earthquake
    • Using antihypertensive medication,
    • No change in antihypertensive drug treatment has been made in the last month,
    • Computer/tablet/smartphone etc. to watch videos. having technological devices,
    • Having internet access,
    • Being over 40 years old,
    • Education level must be at least primary education level

Exclusion Criteria:

  • Being pregnant or breastfeeding
  • Presence of another accompanying chronic disease (Diabetes mellitus, cancer, chronic renal failure, chronic obstructive pulmonary disease, heart failure, etc.),
  • Having physical (speech, hearing impairment, etc.), neurological and psychological problems that prevent filling out research forms and participating in training.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With Tele-Nursing
no With Tele-Nursing
Other Names:
  • Control
No Intervention: Control
no With Tele-Nursing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hill-Bone Hypertension Treatment Compliance Scale
Time Frame: 12 week
The scale consists of 14 questions. On a four-point Likert scale (0=never, 1=sometimes, 2=most of the time and 3=always), interview (items 6, 7 and 8), medical (items 1, 2, 9, 10, 11, 12, 13) and 14) and nutrition (items 3, 4 and 5). Except for the 6th question of the scale, all other questions are in the form of negative questions. Total scores from the scale vary between 0 and 42, with 0 points indicating perfect compliance with treatment. A high total score from the scale indicates decreased compliance with treatment.
12 week
Self-Care Management Scale in Chronic Diseases;
Time Frame: 12 week
The scale consists of 35 items and is a five-point Likert type (1=strongly disagree, 2=disagree, 3=undecided, 4=agree, 5=strongly agree). The scale includes self-protection (items 2, 6, 8, 11, 15, 18, 19, 20, 22, 23, 25-34), and social protection (items 1, 3, 4, 5, 7, 9, 10, 12). It has two sub-dimensions: , 13, 14, 16, 17, 21, 24 and 35 items). The 3rd, 15th, 19th and 28th items 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.
12 week
Psychological Impact of Earthquake Scale:
Time Frame: 12 week
The scale consists of 41 items. The scale is a 5-point Likert (1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree, 5: Strongly Agree). There are 6 sub-dimensions. As the score on the scale increases, the psychological impact of the earthquake on individuals increases. Scale Cronbach's Alpha values vary between 0.84 and 0.96.
12 week
Earthquake Stress Coping Strategies Scale
Time Frame: 12 week
The scale consists of 16 items and has 3 subscales. A 4-point rating was used in the scale: Always (4) and Never (1). However, in the Social Support Seeking subscale, Item 4 (I try to keep my feelings to myself) and Item 12 (I prefer not to talk about my fears and concerns) are scored in the opposite direction because they indicate that the individual does not seek social support. The score ranges of the Religious Coping and Social Support Seeking subscales, each consisting of 5 items, are 5-20, and the score range of the Positive Reappraisal subscale, consisting of 6 items, is 6-24. A high score for each dimension indicates that the individual uses that coping strategy more, while a low score indicates that the individual uses it less
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/05-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on With Tele-Nursing

Clinical Trials on With Tele-Nursing

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