With Tele-NursingNCT06350136
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 study testing With Tele-Nursing in people with With Tele-Nursing, run by Firat University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- With Tele-Nursing
- What is being tested?
- With Tele-Nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- With Tele-Nursing
- Being tested
- With Tele-Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With Tele-NursingBehavioural
Also called Control
no With Tele-Nursing
| Study group | Role | What they receive |
|---|---|---|
| With Tele-Nursing | Experimental | With Tele-Nursing Receives: Behavioral: With Tele-Nursing |
| Control | No intervention | no With Tele-Nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hill-Bone Hypertension Treatment Compliance Scale
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.
Measured: 12 week
Self-Care Management Scale in Chronic Diseases;
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.
Measured: 12 week
Psychological Impact of Earthquake Scale:
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.
Measured: 12 week
Earthquake Stress Coping Strategies Scale
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
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for With Tele-NursingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350136
- Sponsor's protocol ID
- 2024/05-37
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06350136
- Acronym / sponsor ID
- 2024/05-37
- Conditions
- With Tele-Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Tele-Nursing | Experimental | Behavioral: With Tele-NursingWith Tele-Nursing |
| Control | No intervention | –no With Tele-Nursing |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Being followed for at least 6 months with the diagnosis of essential hypertension,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| With Tele-NursingAlso: Controlno With Tele-Nursing | Behavioural | With Tele-Nursing |
Primary outcome
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.
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing With Tele-Nursing in people with With Tele-Nursing, run by Firat University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülcan Bahçecioğlu Turan (05065576086, glcnbah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hill-Bone Hypertension Treatment Compliance Scale (time frame: 12 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.