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StrokeNCT05484843

The Effect of Health Promotion Training on Life Qualities and Self-Care Powers in Stroke Patients

A study testing telenursing training based on self-care theory and just observation in people with Stroke and Nursing Caries, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There are many methods that nurses use while providing care education to individuals. Tele-nursing, which is one of the current methods, is an innovative approach, but it is a useful method in meeting the post-discharge home care needs of patients who are dependent or partially dependent on others and who live in… Read more about this study

Who is it for?
Any age
Conditions the study is for
Stroke, Nursing Caries, Quality of Life
What is being tested?
telenursing training based on self-care theory and just observation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Apr 2021to 1 Jul 2022
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Being over 18 years old
  • Being of all genders, male and female
  • Being able to communicate in Turkish
  • Having had a hemorrhagic or ischemic stroke
  • Not more than one month after the stroke event.
  • Being oriented to person, place and time
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  • Not being aphasic
  • Having a score of 21 or above on the Montreal Cognitive Assessment Scale (MOBİD)
  • Not having serious vision and hearing problems
  • Not having a psychiatric history
  • Being open to communication and cooperation
  • To be willing and voluntarily to participate in the study.

Who cannot join

  • Being under the age of 18
  • Lack of orientation to person, place and time
  • Being aphasic
  • Having a score below 21 on the Montreal Cognitive Assessment Scale (MOCA)
  • Not being willing and voluntarily to participate in the study
  • Having developed an acute condition that may affect the patient's prognosis during the data collection process.
Show all 14Show fewer
  • To have had a secondary stroke or to be exitus during the follow-up period.
  • Being under the age of 18,
  • Not being oriented to person, place and time,
  • Being aphasic,
  • Having a score below 21 on the Montreal Cognitive Assessment Scale (MOBİD),
  • Not being willing or voluntarily to participate in the study,
  • Having developed an acute condition that may affect the patient's prognosis during the data collection process,
  • To have had a secondary stroke or to be exitus during the follow-up period.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ondokuz Mayis University

    Samsun, Atakum, 55139

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Health Promotion Training on Life Qualities and Self-Care Powers in Turkish Stroke Patients : A Longitudinal Study

There are many methods that nurses use while providing care education to individuals. Tele-nursing, which is one of the current methods, is an innovative approach, but it is a useful method in meeting the post-discharge home care needs of patients who are dependent or partially dependent on others and who live in areas far from health care institutions. In today's health care delivery system, it is of great importance to develop a tele-nursing-based care approach by making effective infrastructure studies related to tele-nursing services. Although a limited number of studies have been conducted on different patient groups regarding the tele-nursing method in Turkey, no study has been found that determines the effect of tele-nursing education on patients' quality of life and self-care power in stroke patients. In this respect, it is thought that it is important to conduct studies that will examine the effects of tele-nursing on patients who need long-term care such as stroke at the national level.

The aim of this study is to find out the effects of telenursing training based on self-care theory which was given to patients diagnosed with stroke on quality of life and self-care agency.

Read the detailed description

In the study, the relatives of the patients in the study and control groups were determined by simple randomization method. As a result of the power analysis to determine the sample number of the study, when the study group evaluated according to the literature similar to the basic features of the study; G power test was determined that there should be a minimum of 35 patients in each group, with a confidence interval of 95% and a test power of 99.25%. Which patient would be assigned to the study or control group was decided by randomization. Study and control group patients were first evaluated in terms of the suitability of sample characteristics. Study and control group patients were first evaluated in terms of the suitability of sample characteristics. Written informed consent will then be obtained from the patient. Patients who experienced an acute condition that could negatively affect their quality of life and self-care power during the data collection process and patients who had a secondary stroke during this period were excluded from the study.

The pretest-posttest control group model will be used quantitatively between the dates of this research, which is planned as a randomized controlled study. Scientific ethics committee permission and permission from the hospital were obtained for the collection of research data. The research was carried out in two stages. In the first stage of the study, a nursing care guide specific to stroke patients was prepared based on Self-Care Theory. The content of the developed care guide has been prepared in line with the literature. In the second stage of the study, the study and control group patients were determined by simple randomization method. During the randomization process, 35 patients were assigned to the study group and 35 patients to the control group. Study and control group patients were first evaluated in terms of the suitability of sample characteristics. At the beginning of the study, both the study and control group patients included in the sample group will be given a Patient Information Form as a pre-test, Katz Daily Living Activities Scale, Stroke-Specific Quality of Life Scale and Self-Care Strength Scale to provide general information about the degree of addiction of the patients. Written permission was obtained from the scale developers for each scale. After the pre-test, patients in the study group will be given training and brochures in line with the nursing care guide based on Self-Care Theory before discharge. The training, which will be given based on the Theory of Self-Care, is 30-60 minutes, between 12:00 and 16:00 on Mondays of every week via telephone. carried out throughout. Tele-nursing training, which will be given to the study group by telephone, will last for 12 weeks. In addition, patients were given the opportunity to ask their questions over the phone whenever they wished.

At the end of the 12th week, the Stroke-Specific Quality of Life Scale and Self-Care Strength Scale were administered to the study group patients via telephone as a post-test, and the data were recorded. In the study, routine discharge training of the clinic will be given to the control group before discharge. No application was made to the control group for 12 weeks. At the end of the 12th week, the patients' data were recorded with the Stroke-Specific Quality of Life Scale and the Self-Care Strength Scale as a post-test. In order to prevent possible ethical problems, after the post-test was applied to the control group patients at the end of the 12th week, tele-nursing training was given to the stroke patients in line with the care guide prepared based on the self-care theory, and the questions of the patients were answered.

Being tested
telenursing training based on self-care theory, just observation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telenursing training based on self-care theoryBehavioural

    • A training guide based on the self-care theory specific to individuals diagnosed with stroke was prepared.
    • Identification of the study/control group (randomization)
    • Patients were informed and consents were obtained.
    • Sample suitability was evaluated in line with the cognitive levels and inclusion criteria of patients diagnosed with stroke.
    • All patients included in the sample group were pre-tested before discharge.
    • Training was offered for the study group patients in line with the guide prepared based on self-care theory.
    • Tele-nursing training was applied to the study group patients.
    • Control group patients were followed up
    • Post-tests were administered at the end of the 12-week period
    • The training of the control group patients was completed
    • Your data has been evaluated
  • just observationBehavioural

    For 3 months, patients were observed without intervention. The standard discharge training of the clinic was given.

Study groups in NCT05484843
Study groupRoleWhat they receive
Stroke patients_intervention groupExperimentalInclusion criteria for the study: * Being over 18 years old * Being of all genders, male and female * Being able to communicate in Turkish * Having had a hemorrhagic or ischemic stroke * Not more than one month after the stroke event. * Being oriented to person, place and time * Not being aphasic * Having a score of 21 or above on the Montreal Cognitive Assessment Scale (MOBİD) * Not having serious vision and hearing problems * Not having a psychiatric history * Being open to communication and cooperation * To be willing and voluntarily to participate in the study.
Receives: Behavioral: telenursing training based on self-care theory; Behavioral: just observation
stroke patients_control groupExperimentalInclusion criteria for the study: * Being over 18 years old * Being of all genders, male and female * Being able to communicate in Turkish * Having had a hemorrhagic or ischemic stroke * Not more than one month after the stroke event. * Being oriented to person, place and time * Not being aphasic * Having a score of 21 or above on the Montreal Cognitive Assessment Scale (MOBİD) * Not having serious vision and hearing problems * Not having a psychiatric history * Being open to communication and cooperation * To be willing and voluntarily to participate in the study.
Receives: Behavioral: telenursing training based on self-care theory; Behavioral: just observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changing Quality of Life Scale

    Stroke Specific Quality of Life Scale The original scale, which consists of 49 items, consists of 12 domains that evaluate mobility, energy, upper extremity function, self-care, occupation/productivity, temperament, social role, family role, vision, language, thinking, and personality traits.

    The stroke-specific quality of life scale is a 5-point Likert type and can be scored from 1 to 5 points according to the statements given.

    The average score that can be obtained from each sub-dimension is between 1 point and 5 points. The score obtained from the scale; It is calculated by dividing the sum of the points obtained from each item by the number of items. The sub-dimension mean score is calculated by dividing the total sub-dimension score by the number of sub-dimension items. A high mean score of the scale indicates that the quality of life also improves positively.

    Measured: pre-training

  2. Changing Self-Care Power

    Examination of Self-Care Agency Scale The Self-Care Power Scale consists of 35 items to determine the self-care skills of individuals and is shaped on 4 basic characteristics. These; Among the situations, active and passive response, motivation, knowledge of health practices, individuals' own feelings and values. The Self-Care Strength Scale is a 5-point Likert type and can be scored from 0 to 4 according to the statements given.

    8 of the questions (3,6,9,13,19,22,26,31) are evaluated in reverse. The highest 140 points can be obtained from the scale. It is accepted that as the score obtained from the scale increases in line with the answers of the individuals, the level of self-care power also increases.

    Measured: pre-training

  3. Daily Life Activities

    Katz Daily Life Activities Scale Katz Daily Living Activities Scale consists of 6 questions including information about bathing, dressing, toilet, movement, excretion, feeding activities.

    Evaluation is made by giving 3 points if the individual performs the activities of daily living independently, 2 points if he/she does it with assistance, and 1 point if he/she cannot do it at all. Katz Activities of Daily Living Scale; 0-6 points as "dependent", 7-12 points as "semi-dependent", 13-18 points as "independent".

    Measured: pre-training

Secondary outcomes (2)
  1. Changing Quality of Life

    Stroke Specific Quality of Life Scale The original scale, which consists of 49 items, consists of 12 domains that evaluate mobility, energy, upper extremity function, self-care, occupation/productivity, temperament, social role, family role, vision, language, thinking, and personality traits.

    The stroke-specific quality of life scale is a 5-point Likert type and can be scored from 1 to 5 points according to the statements given.

    The average score that can be obtained from each sub-dimension is between 1 point and 5 points. The score obtained from the scale; It is calculated by dividing the sum of the points obtained from each item by the number of items. The sub-dimension mean score is calculated by dividing the total sub-dimension score by the number of sub-dimension items. A high mean score of the scale indicates that the quality of life also improves positively.

    Measured: post-training (3 months later)

  2. Changing Self-Care Power

    Examination of Self-Care Agency Scale The Self-Care Power Scale consists of 35 items to determine the self-care skills of individuals and is shaped on 4 basic characteristics. These; Among the situations, active and passive response, motivation, knowledge of health practices, individuals' own feelings and values. The Self-Care Strength Scale is a 5-point Likert type and can be scored from 0 to 4 according to the statements given.

    8 of the questions (3,6,9,13,19,22,26,31) are evaluated in reverse. The highest 140 points can be obtained from the scale. It is accepted that as the score obtained from the scale increases in line with the answers of the individuals, the level of self-care power also increases.

    Measured: post-training (3 months later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2022
  2. Study start10 Apr 2021
  3. Primary completion10 May 2022
  4. Study completion1 Jul 2022

Resources

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
Model description
The study was in the experimental type and was conducted as a longitudinal, randomized controlled study according to the pretest-posttest trial model.
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05484843
Sponsor's protocol ID
Ondokuzmayis1919
Status last verified
Jul 2022
First submitted
28 Jul 2022
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Other researchers may view the study once it is published.

Publications

  • Spassova L, Vittore D, Droste DW, Rosch N. Randomised controlled trial to evaluate the efficacy and usability of a computerised phone-based lifestyle coaching system for primary and secondary prevention of stroke. BMC Neurol. 2016 Feb 9;16:22. doi: 10.1186/s12883-016-0540-4.

    PubMed 26861865
  • Lin S, Xiao LD, Chamberlain D, Ullah S, Wang Y, Shen Y, Chen Z, Wu M. Nurse-led health coaching programme to improve hospital-to-home transitional care for stroke survivors: A randomised controlled trial. Patient Educ Couns. 2022 Apr;105(4):917-925. doi: 10.1016/j.pec.2021.07.020. Epub 2021 Jul 14.

    PubMed 34294494
  • Kalav S, Bektas H, Unal A. Effects of Chronic Care Model-based interventions on self-management, quality of life and patient satisfaction in patients with ischemic stroke: A single-blinded randomized controlled trial. Jpn J Nurs Sci. 2022 Jan;19(1):e12441. doi: 10.1111/jjns.12441. Epub 2021 Jul 15.

    PubMed 34264000

Questions about this trial

What is this clinical trial studying?

A study testing telenursing training based on self-care theory and just observation in people with Stroke and Nursing Caries, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

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 12 inclusion and 14 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: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changing Quality of Life Scale (time frame: pre-training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05484843, which also lists 3 linked publications.

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 2 Aug 2022.

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