Elderly Cardiac Patients With Multimorbidity and Burnout Among Their CaregiversNCT05475496
Quality of Life of Elderly Patients and Burnout Among Their Care Givers
An observational study of Elderly Cardiac Patients With Multimorbidity and Burnout Among Their Caregivers, run by Sohag University.
Trial summary
Older people with multimorbidity are frequent users of health care services, and there is a relationship between the number of chronic conditions and health care costs. In addition, multimorbidity increases the risk of mortality and functional decline, and this negatively impacts health-related quality of life . Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly Cardiac Patients With Multimorbidity and Burnout Among Their Caregivers
- What is being tested?
- Measurements of quality of life and burnout
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Dec 2023
- Phase
- Observational
- 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 60 years and older
- All sexes
- Adult, Older adult
Study population: Elderly patients with multimorbidity attending cardiac out patient clinic in Sohag University hospital and their caregivers
Who may be able to join
- elderly patients (60 years and over) [2] with multimorbid conditions and a cardiovascular disease is one of them .
- caregivers of elderly patients included in the study.
Who cannot join
- patients and caregivers who will refuse to participate in this study and patients with disturbed conscious level and mentally disabled.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Quality of Life of Elderly Cardiac Patients With Multimorbidity and Prevalence of Burnout Among Their Caregivers in Sohag Governorate
Older people with multimorbidity are frequent users of health care services, and there is a relationship between the number of chronic conditions and health care costs. In addition, multimorbidity increases the risk of mortality and functional decline, and this negatively impacts health-related quality of life
. Furthermore, research tends to focus on individual organ systems, often ignoring the complexity of care for older people with multimorbidity. Moreover, patient QoL is a meaningful measure in the evaluation of health care services and patient-reported outcome Caregiving demands significantly reduce caregivers' opportunities to have a lifestyle in which leisure or time for themselves is available. According to different empirically supported theoretical frameworks that point to the importance for caregivers of experiencing pleasant events and receiving positive reinforcement in their daily lives in order to maintain a positive mood, not engaging in personally satisfying activities may result in more social withdrawal and depression, putting caregivers at risk of developing emotional disorders.
Read the detailed description
As the percentage of elderly cardiac population is growing and most of them have multimorbid conditions, we should find ways to improve their of life and to avoid their caregivers being burned out.
Asses quality of life of cardiac elderly patients with multimorbidity and to investigate the prevalence of burnout among their caregivers This study of multimorbidity among elderly cardiac patients attending Sohag university cardiac outpatient clinic and burnout among their care givers aims to:-
- Study the effect of multimorbidity on health related quality of life of elderly cardiac patients.
- Study determinants of health related quality of life among elderly cardiac patients with multimorbidity.
- Study burnout prevalence among care givers
- Being tested
- Measurements of quality of life and burnout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of quality of life and burnoutOther
WHOQOL-Bref questionnaire to assess the health related quality of life of the elderly cardiac patients. WHOQOL-Bref assesses Physical health (7 items), Psychological health (6 items), Social relationships (3 items) and the environment ( 8 items ), in addition to two items asking about overall perception of life and general health. Items are rated on a 5 point ordinal scale, domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
Maslach Burnout Inventory questionnaire to measure burnout among caregivers, it includes 3 components: emotional exhaustion (9 items), depersonalization(5items) and personal accomplishment(8 items).
| Study group | Role | What they receive |
|---|---|---|
| Elderly cardiac patients with multimorbidity and their caregivers | elderly patients (60 years and over) [2] with multimorbid conditions and a cardiovascular disease is one of them .
caregivers of elderly patients included in the study Receives: Other: Measurements of quality of life and burnout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of elderly patients
Measuring the quality of life of elderly patients with cardiovascular and other morbid conditions using WHOQOL-Bref questionnaire
Measured: 6 months
Burnout among caregivers
Measuring the prevalence of burnout among caregivers using Maslach Burnout Inventory questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Cardiac Patients With Multimorbidity and Burnout Among Their CaregiversStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Harris Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475496
- Sponsor's protocol ID
- Soh-Med-22-06-15
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Elderly Cardiac Patients With Multimorbidity and Prevalence of Burnout Among Their Caregivers in Sohag Governorate
- ClinicalTrials.gov ID
- NCT05475496
- Acronym / sponsor ID
- Soh-Med-22-06-15
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older people with multimorbidity are frequent users of health care services, and there is a relationship between the number of chronic conditions and health care costs. In addition, multimorbidity increases the risk of mortality and functional decline, and this negatively impacts health-related quality of life
. Furthermore, research tends to focus on individual organ systems, often ignoring the complexity of care for older people with multimorbidity. Moreover, patient QoL is a meaningful measure in the evaluation of health care services and patient-reported outcome Caregiving demands significantly reduce caregivers' opportunities to have a lifestyle in which leisure or time for themselves is available. According to different empirically supported theoretical frameworks that point to the importance for caregivers of experiencing pleasant events and receiving positive reinforcement in their daily lives in order to maintain a positive mood, not engaging in personally satisfying activities may result in more social withdrawal and depression, putting caregivers at risk of developing emotional disorders.
Detailed description
As the percentage of elderly cardiac population is growing and most of them have multimorbid conditions, we should find ways to improve their of life and to avoid their caregivers being burned out.
Asses quality of life of cardiac elderly patients with multimorbidity and to investigate the prevalence of burnout among their caregivers This study of multimorbidity among elderly cardiac patients attending Sohag university cardiac outpatient clinic and burnout among their care givers aims to:-
- Study the effect of multimorbidity on health related quality of life of elderly cardiac patients.
- Study determinants of health related quality of life among elderly cardiac patients with multimorbidity.
- Study burnout prevalence among care givers
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly cardiac patients with multimorbidity and their caregivers | – | Other: Measurements of quality of life and burnoutelderly patients (60 years and over) [2] with multimorbid conditions and a cardiovascular disease is one of them . caregivers of elderly patients included in the study |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Elderly patients with multimorbidity attending cardiac out patient clinic in Sohag University hospital and their caregivers
Key inclusion criteria (2 listed)
- elderly patients (60 years and over) [2] with multimorbid conditions and a cardiovascular disease is one of them .
- caregivers of elderly patients included in the study.
Key exclusion criteria (1 listed)
- patients and caregivers who will refuse to participate in this study and patients with disturbed conscious level and mentally disabled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurements of quality of life and burnoutWHOQOL-Bref questionnaire to assess the health related quality of life of the elderly cardiac patients. WHOQOL-Bref assesses Physical health (7 items), Psychological health (6 items), Social relationships (3 items) and the environment ( 8 items ), in addition to two items asking about overall perception of life and general health. Items are rated on a 5 point ordinal scale, domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Maslach Burnout Inventory questionnaire to measure burnout among caregivers, it includes 3 components: emotional exhaustion (9 items), depersonalization(5items) and personal accomplishment(8 items). | Other | Elderly cardiac patients with multimorbidity and their caregivers |
Primary outcome
Quality of life of elderly patients
Time frame: 6 months
Measuring the quality of life of elderly patients with cardiovascular and other morbid conditions using WHOQOL-Bref questionnaire
Burnout among caregivers
Time frame: 6 months
Measuring the prevalence of burnout among caregivers using Maslach Burnout Inventory questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly Cardiac Patients With Multimorbidity and Burnout Among Their Caregivers, run by Sohag University.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa Ahmed, Master (01098626250, shimaa.hares@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of elderly patients (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2022.