Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05328739
Other study ID # 2019/179
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2019
Est. completion date July 30, 2020

Study information

Verified date April 2022
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was conducted to evaluate the effect of home care planned according to Orem on self-care agency and care burden in brain tumor patients and their caregivers. The study was performed with patients who underwent surgery for a brain tumor and their caregivers in the neurosurgery clinic of a tertiary hospital. Ethical committee approval, institutional permission, patients and their caregiver verbal and written consent were obtained. According to Orem's nursing theory, home care practice combining education, counseling and nursing care started with pre-operative education in the hospital for the patients and caregivers in the intervention group and continued at home with 5 home visits in a 6-month period. Self-Care Agency Scale, MD Anderson Symptom Inventory Brain Tumor-Turkish Form and Caregiver Burden Scale were used as measurement tools in the study.The value of p<0.05 was accepted statistically significant in the data analyses.


Description:

In this randomized controlled experimental study, it was aimed to determine the effect of home care planned according to Orem on self-care agency and care burden in brain tumor patients and their caregivers. The study was performed with patients who underwent surgery for a brain tumor and their caregivers in the neurosurgery clinic of a tertiary hospital. Ethical committee approval, institutional permission, patients and their caregiver verbal and written consent were obtained. According to Orem's nursing theory, home care practice combining education, counseling and nursing care started with pre-operative education in the hospital for the patients and caregivers in the intervention group and continued at home with 5 home visits in a 6-month period. Self-Care Agency Scale, MD Anderson Symptom Inventory Brain Tumor-Turkish Form and Caregiver Burden Scale were used as measurement tools in the study. In addition, measurement tools used in patients and caregivers were applied to an average of 6 month: before surgery preoperative assessment at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3) and after surgery 6th month at home (Time 4). Data were analyzed with descriptive statistics, two-way analysis of variance. Bonferroni correction was applied when comparing the main effects and comparisons between categorical variables and groups were evaluated with Fisher's exact test, p<.05 value was considered statistically significant.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 30, 2020
Est. primary completion date March 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility inclusion criteria for patient; - living within the borders of the region, - being over 18 years old, - being at least literate, being able to communicate in Turkish, - being oriented to person, place and time, not having hearing and speaking problems, - having primar brain tumor (glial or meningeal) surgery, - taking part in grade I, II, III - and having Karnovsky Performance Scale (KPS) score above 50 points. exclusion criteria for patient; - being under the age of 18, - illiterate, unable to communicate in Turkish, - being diagnosed with a neurological and psychiatric disorder that may affect the cognitive status, - not being oriented to the person, place and time, having hearing and speaking problems, - having surgery for a metastatic brain tumor, - having surgery for a pituitary adenoma, to have undergone emergency surgery, to have a biopsy, - to be in grade IV, - to have a KPS score below 50 points. Criteria for terminating the research process; - wanting to leave the research process, - meeting one of the criteria for exclusion from the sample after the surgery, - spending the home care and follow-up process in another province, and/or not being able to reach the individual. inclusion criteria for caregiver; - being over the age of 18, - being literate, being able to communicate in Turkish, and not having hearing and speaking problems, - caring for a patient who had primary brain tumor surgery. exclusion criteria for caregiver ; - being under the age of 18, - illiterate, unable to communicate in Turkish, - being diagnosed with a neurological or psychiatric disorder that may affect the cognitive status, - and having hearing and speech problems. Criteria for terminating the research process; - wanting to leave the research process, - meeting one of the criteria for exclusion from the sample after the surgery, - spending the home care and follow-up process in another province, and/or not being able to reach the individual.

Study Design


Intervention

Other:
home care
home care program

Locations

Country Name City State
Turkey Erciyes University Faculty of Health Science Kayseri Eyalet/Yerleske

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-Care Agency Scale (SCAS) Mean Score SCAS: in order to evaluate the self-care agency of patients and caregiver each measurement was performed before the intervention at the time. The lowest score is 35, the highest score is 140. The highest score shows the greatest degree of self-care agency.Change= preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3). and after surgery 6th month at home (Time 4). An average of 6 month: preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3) and after surgery 6th month at home (Time 4).
Primary MD Anderson Symptom Inventory Brain Tumor-Turkish Form (MDA-BTSETr ) Mean Score MDA-BTSETr: in order to evaluate the symptoms and the impact of the symptoms on the lives of patients, each measurement was performed before the intervention at the time. The inventory consists of two parts that evaluate the symptoms and the interference of the individual's life. In the first part of the inventory, individuals are asked to rate the severity of each symptom in the last 24 hours between 0-10 (0: no symptom, 10: the most severe level of the symptom experienced). In the second part, individuals are asked to rate how much their symptoms interfere with their lives, from 0 to 10 (0: not interfered, 10: completely interfered).Change= preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3). and after surgery 6th month at home (Time 4). An average of 6 month: preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3) and after surgery 6th month at home (Time 4).
Primary Caregiver Burden Scale (CBS) Mean Score CBS: in order to evaluate the care burden of individuals who care for patients who have undergone primary brain tumor surgery, each measurement was performed before the intervention at the time. The lowest score that can be obtained from the scale is 0, the highest score is 88, and an increasing score indicates an increase in the burden of care.Change= preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3). and after surgery 6th month at home (Time 4). An average of 6 month: preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3) and after surgery 6th month at home (Time 4).
Secondary Karnofsky Performance Scale (KPS) Mean Score KPS allows to determine the individual and medical care needs of the patient, to obtain information about symptom severity and level of function at work and home. It is scored between 0-100. The loss of function from normal function (100) to death (0) based on the functional status of the individual. Change= preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3). and after surgery 6th month at home (Time 4). An average of 6 month: preoperative assessment before surgery at hospital (Time 1), after surgery 1st month at home (Time 2) after surgery 3rd month at home (Time 3) and after surgery 6th month at home (Time 4).
See also
  Status Clinical Trial Phase
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A
Recruiting NCT06099197 - I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals N/A
Not yet recruiting NCT05567120 - Pre-Pilot: Problem Adaptation THerapy in Caregivers N/A
Completed NCT00259415 - Telesupport: Evaluation of Professionally Led Support Groups for Caregivers Phase 1
Active, not recruiting NCT05992467 - WECARE: A Behavioral Intervention for Dementia Caregivers N/A
Completed NCT04109209 - Psychological Intervention For Brain Tumor Caregivers N/A
Recruiting NCT05780476 - A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare) N/A
Completed NCT05996718 - Improving Care Through Improv: Promoting Mastery in the Moment N/A
Recruiting NCT06307197 - HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia N/A
Completed NCT05778747 - Feasibility of the Heart to Heart Yoga Program N/A
Not yet recruiting NCT06072274 - Efficacy of VR Educational Program on Empathy and Attitudes Toward Dementia in Caregivers N/A
Recruiting NCT05595850 - A Mindful Community for People With ALS and Their Primary Caregivers N/A
Completed NCT04553679 - Mindfulness After Stroke
Recruiting NCT05178966 - Evaluation of Efficiency of One Day Patient/Caregiver Psychoeducation on the Caregiver's Burden N/A
Recruiting NCT05373537 - Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism N/A
Completed NCT06466239 - PNF Method for Those Working in Special Education N/A
Completed NCT05616572 - Online Educational Tool for Caregivers of Pediatric Oncology Patients N/A
Completed NCT05351528 - of Caregiver Family Members for the Disabled in Bukhara
Completed NCT05762315 - Transformative Audio Storytelling N/A