Clinical trial NCT05484843: The Effect of Health Promotion Training on Life Qualities and Self-Care Powers in Stroke Patients
Official title: The Effect of Health Promotion Training on Life Qualities and Self-Care Powers in Turkish Stroke Patients : A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Nursing Caries
Quality of Life
Self-care
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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.

Primary outcomes:
measure: Changing Quality of Life Scale
timeFrame: pre-training
measure: Changing Self-Care Power
timeFrame: pre-training
measure: Daily Life Activities
timeFrame: pre-training
Secondary outcomes:
measure: Changing Quality of Life
timeFrame: post-training (3 months later)
measure: Changing Self-Care Power
timeFrame: post-training (3 months later)
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.