ClinicalTrials.gg
CompletedNCT05484843Updated Aug 2, 2022

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

An interventional study of telenursing training based on self-care theory and just observation in Stroke, Nursing Caries and Quality of Life, sponsored by Ondokuz Mayıs University. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2022-08-02.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Apr 2021, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stroke
  • Nursing Caries
  • Quality of Life
  • Self-care

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03

In context

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 70 is above the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 272 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Inclusion 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.

Exclusion Criteria:

  • 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.
  • To have had a secondary stroke or to be exitus during the follow-up period.

Exclusion criteria from the study:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Stroke patients_intervention group

    Inclusion 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.

    Behavioral: telenursing training based on self-care theory · Behavioral: just observation

  • Experimental
    stroke patients_control group

    Inclusion 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.

    Behavioral: telenursing training based on self-care theory · Behavioral: just observation

Interventions

  • Behavioraltelenursing training based on self-care theory

    * 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

  • Behavioraljust observation

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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".

    Time frame: pre-training

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: post-training (3 months later)

07

Study locations

1 site
  • Ondokuz Mayis University
    Samsun, Atakum 55139, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: No — Other researchers may view the study once it is published.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2021 to primary completion in May 2022, 13 months.

Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 13 months is below that.

Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2022
First posted
Aug 2, 2022
StartActual
Apr 10, 2021
Primary completionActual
May 10, 2022
CompletionActual
Jul 1, 2022
Last update
Aug 2, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05484843
Responsible party
Cansev BAL (Cansev BAL, Phd. Candidate, Principle Investigator, Ondokuz Mayıs University, Ondokuz Mayıs University) — Principal investigator
First posted
Aug 2, 2022
Start date
Apr 10, 2021
Primary completion
May 10, 2022
Completion
Jul 1, 2022
Last update
Aug 2, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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