A survey investigating health-related quality of life in adolescents with moyamoya disease
| ISRCTN | ISRCTN24696854 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24696854 |
| Secondary identifying numbers | SHAM123, NRF-2019R1AC1004633 |
- Submission date
- 09/12/2021
- Registration date
- 09/12/2021
- Last edited
- 20/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Moyamoya disease is a chronic (long-term) progressive (that gets worse with time) disease of the blood vessels of the brain (cerebrovascular) that requires regular monitoring to control the disease and its related complications. Moyamoya disease can lead to stroke or bleeding in the brain or stroke. It can also affect brain function and cause disability.
This study aims to investigate whether understanding of the disease, a sense of coherence and social support were significant factors contributing to lower stress, improved health, and quality of life in adolescents with moyamoya disease. This study aims to help health experts to develop a treatment strategy based on a health and wellbeing approach for chronic disease management.
Who can participate?
Adolescents who have had moyamoya disease for longer than one month with no other diseases.
What does the study involve?
Participants will complete questionnaires about social support, sense of coherence, stress, health behavior, health status, and quality of life on a single occasion.
What are the possible benefits and risks of participating?
The potential benefits to participants are that they might better understand the factors affecting their health-related quality of life with moyamoya disease and other chronic diseases.
There are no anticipated risks as this study is a survey.
Where is the study run from?
Yonsei University (Korea, South)
When is the study starting and how long is it expected to run for?
From November 2017 to October 2018
Who is funding the study?
National Research Foundation of Korea (NRF) (Korea, South)
Who is the main contact?
Prof Insun Yeom
ruthin76@yuhs.ac
Contact information
Public
Jeunggaro 150
Seoul
03670
Korea, South
 ORCID ID |
0000-0001-9914-9486 |
|---|---|
| Phone | +82-10-9018-5666 |
| ruthin76@yuhs.ac |
Study information
| Study design | Cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | No participant information sheet available |
| Scientific title | Structural equation model of health-related quality of life in adolescents with moyamoya disease: based on the salutogenesis theory |
| Study objectives | Knowledge of moyamoya disease, social support, and sense of coherence affect individual stress and health behaviors, in turn affecting subjective health status, depression, and quality of life |
| Ethics approval(s) | Approved 11/07/2017, Severance Hospital Institutional Review Board (Yonsei University Health System, 50-1 Yeonse-ro, Seodaemun-gu, Seoul 03722, Korea; +82-02-2228-0450; irb@yuhs.ac) |
| Health condition(s) or problem(s) studied | Adolescents with Moyamoya disease |
| Intervention | The study involves a cross-sectional survey of Korean adolescents with Moyamoya disease. The study will examine a hypothetical model by integrating the concepts of a structural health-related quality-of-life model based on the salutogenesis theory among adolescents with moyamoya disease in Korea. Data on health-related quality of life of adolescents with moyamoya disease will be collected at a single timepoint using the following scales: social support rating scale, sense of coherence scale, stress scale, health behavior scale, subjective health status scale, and quality-of-life scale. A structural equation model will be used to analyze the data. |
| Intervention type | Other |
| Primary outcome measure | 1. Subjective health status measured using a 5-point simple-question Likert scale, ranging from 1 point (very bad) to 5 points (very good) at a single timepoint 2. Quality of life measured using a quality of life scale (Varni et al., 1998) at a single timepoint |
| Secondary outcome measures | 1. Social support measured using a social support scale (Malecki et al., 2000) at a single timepoint. Higher scores indicate more social support in each area. 2. Sense of coherence measured using a sense of coherence scale (Antonovsky, 1987) at a single timepoint 3. Health behavior measured using the moyamoya health behavior scale (Oh et al., 2021) at a single timepoint. Higher scores indicate better health behaviors related to moyamoya disease. 4. Stress measured using the stress scale for adolescents (Kim and Bae, 2014) at a single timepoint |
| Overall study start date | 01/11/2017 |
| Completion date | 30/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 230 |
| Total final enrolment | 239 |
| Key inclusion criteria | 1. Moyamoya disease for >1 month 2. No other diseases 3. Able to respond to a questionnaire. 4. Able to confirm their understanding of the purpose of the study and agree to participate voluntarily providing online written consent 5. Aged between 13 and 18 years |
| Key exclusion criteria | 1. History of mental illness 2. Difficulty in participating (e.g. hearing and visual impairment) |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 30/10/2018 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Pediatric Neurosurgery
50-1 Yeonse-ro
Seodaemun-gu
Seoul
03722
Korea, South
Sponsor information
University/education
50-1 Yeonse-ro
Seodaemun-gu
Seoul
03722
Korea, South
| Phone | +82-02-2228-3253 |
|---|---|
| in-ji@hanmail.net | |
| Website | http://www.yonsei.ac.kr/eng/ |
"ROR" |
https://ror.org/01wjejq96 |
Funders
Funder type
Government
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- 한국연구재단이 창의적 연구와, National Research Foundation (South Korea), NRF
- Location
- Korea, South
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in an open-access journal. |
| IPD sharing plan | Data will be made available upon request to Prof Won-oak Oh (wooh@korea.ac.kr) |
Editorial Notes
09/12/2021: Trial’s existence confirmed by Severance Hospital Institutional Review Board.
