Caregiver BurnoutNCT05542472
The Effect on Caregivers of a Family Support Program
A study testing Family Support Program Based on a Nurse-Led Case Management Model in people with Caregiver Burnout, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effect of a family support program based on the nurse-led case management model on individuals providing care for patients who are confined to bed at home. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burnout
- What is being tested?
- Family Support Program Based on a Nurse-Led Case Management Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2020to 2 Aug 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study,
- To have been taking care of the caregiver for at least 6 months,
- Being literate
- Not to have sensory loss such as vision and hearing,
- Being open to communication and cooperation,
- Internet access and being able to use it,
Show all 9Show fewer
- Having a phone where he can be reached,
- Not receiving any remuneration for the provision of care,
- Having a family bond with the person being cared for.
Who cannot join
- Caregivers who do not meet the inclusion criteria,
- Caregivers who did not give consent at any stage of the study and left.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University of Applied Sciences
Sakarya, 54000
About this study
Official title: The Effect on Caregivers of a Family Support Program Based on a Nurse-Led Case Management Model
The purpose of this study is to investigate the effect of a family support program based on the nurse-led case management model on individuals providing care for patients who are confined to bed at home.
Read the detailed description
It is of paramount importance to enable the patients receiving home care and their relatives to adapt social life, to fulfil their social integration, to relieve the burden of family members of the individual in need of care, especially the individual providing care, by supporting them in the environment where they live. In this study, it is aimed to investigate the effect of the family support program based on the nurse-led case management model for family members who care for bedridden patients.The family support program based on a five-stage nurse-led case management model is administered for the caregivers in the intervention group, the caregivers in the control group is monitored by home health services through routine follow-ups. The research will conducted as a randomized controlled study with an experimental design.
- Conditions
- Caregiver Burnout
- Being tested
- Family Support Program Based on a Nurse-Led Case Management Model
- Keywords
- caregiver, case management, nurse-led
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Support Program Based on a Nurse-Led Case Management ModelOther
A Family Support Program Based on the Nurse-Led Case Management Model create for the care givers in the intervention group. Case management is the process of planning an individual's care, coordinating it, managing it, implementing it and reviewing it. The aim in case management is to improve a person's quality of life by coordinating health care services and providing these services at a reasonable cost and in a productive way. The use of case management requires the cooperation of professionals from many different disciplines. Therefore, in areas where case management is applied, the case manager coordinates an individual's or patient's care by enabling this cooperation. In this way, in areas where health services are provided, the case manager may be a doctor, a nurse, a physiotherapist, a social services expert, or a speech therapist.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention will perform on the caregivers in the control group. The patients will continue to receive care under public services. |
| Interventional group | Experimental | A Family Support Program Based on the Nurse-Led Case Management Model will create for the caregivers in the intervention group. The nurse-led case management model is made up of five basic nursing activities.
First Nursing Activity: Determining individuals who can benefit from the case management model Second Nursing Activity: Establishing individuals' problems and care needs Third Nursing Activity: Planning nursing activities to meet the determined needs Fourth Nursing Activity: Implementing nursing activities Fifth Nursing Activity: Regular review, monitoring and assessment of nursing activities Receives: Other: Family Support Program Based on a Nurse-Led Case Management Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregiver burden in 6 months
Zarit Caregiver Burden Scale: This scale was developed in 1980 by Zarit et al. to assess the stress experienced by those providing care to old people or to those in need of care. The lowest possible score is 0 and the highest is 88. A high score on the scale shows a high level of distress experienced.
Measured: 6 months
Secondary outcomes (1)
assessment of caregivers' quality of life
WHOQOL-BREF-TR Form: This form is the Turkish adaptation of the WHOQOL-100, which was developed by the World Health Organization to assess the quality of life of individuals. Cultural adaptation of the WHOQOL-BREF-TR in Turkey and validity and reliability work were conducted by Eser et al. (1999). This scale consists of 26 questions selected from the WHOQOL-BREF WHOQOL-100 scale. One item was added to the Turkish version of the scale.
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 posted15 Sep 2022
- Study start11 Mar 2020
- Primary completion30 Nov 2020
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurnoutStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatma tanrıkulu, Sakarya University
- Investigators
- Yurdanur Dikmen, Prof. Dr., Study director, Sakarya Applied Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542472
- Sponsor's protocol ID
- 16214662/050.0104/127
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Caregivers of a Family Support Program Based on a Nurse-Led Case Management Model
- ClinicalTrials.gov ID
- NCT05542472
- Acronym / sponsor ID
- 16214662/050.0104/127
- Conditions
- Caregiver Burnout
- Keywords
- caregiver, case management, nurse-led
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 15 Sep 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.
The purpose of this study is to investigate the effect of a family support program based on the nurse-led case management model on individuals providing care for patients who are confined to bed at home.
Detailed description
It is of paramount importance to enable the patients receiving home care and their relatives to adapt social life, to fulfil their social integration, to relieve the burden of family members of the individual in need of care, especially the individual providing care, by supporting them in the environment where they live. In this study, it is aimed to investigate the effect of the family support program based on the nurse-led case management model for family members who care for bedridden patients.The family support program based on a five-stage nurse-led case management model is administered for the caregivers in the intervention group, the caregivers in the control group is monitored by home health services through routine follow-ups. The research will conducted as a randomized controlled study with an experimental design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention will perform on the caregivers in the control group. The patients will continue to receive care under public services. |
| Interventional group | Experimental | Other: Family Support Program Based on a Nurse-Led Case Management ModelA Family Support Program Based on the Nurse-Led Case Management Model will create for the caregivers in the intervention group. The nurse-led case management model is made up of five basic nursing activities. First Nursing Activity: Determining individuals who can benefit from the case management model Second Nursing Activity: Establishing individuals' problems and care needs Third Nursing Activity: Planning nursing activities to meet the determined needs Fourth Nursing Activity: Implementing nursing activities Fifth Nursing Activity: Regular review, monitoring and assessment of nursing activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Volunteering to participate in the study,
- To have been taking care of the caregiver for at least 6 months,
- Being literate
- Not to have sensory loss such as vision and hearing,
- Being open to communication and cooperation,
Key exclusion criteria (2 listed)
- Caregivers who do not meet the inclusion criteria,
- Caregivers who did not give consent at any stage of the study and left.
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 |
|---|---|---|
| Family Support Program Based on a Nurse-Led Case Management ModelA Family Support Program Based on the Nurse-Led Case Management Model create for the care givers in the intervention group. Case management is the process of planning an individual's care, coordinating it, managing it, implementing it and reviewing it. The aim in case management is to improve a person's quality of life by coordinating health care services and providing these services at a reasonable cost and in a productive way. The use of case management requires the cooperation of professionals from many different disciplines. Therefore, in areas where case management is applied, the case manager coordinates an individual's or patient's care by enabling this cooperation. In this way, in areas where health services are provided, the case manager may be a doctor, a nurse, a physiotherapist, a social services expert, or a speech therapist. | Other | Interventional group |
Primary outcome
Change in caregiver burden in 6 months
Time frame: 6 months
Zarit Caregiver Burden Scale: This scale was developed in 1980 by Zarit et al. to assess the stress experienced by those providing care to old people or to those in need of care. The lowest possible score is 0 and the highest is 88. A high score on the scale shows a high level of distress experienced.
1 secondary outcome
assessment of caregivers' quality of life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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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.
Yurdanur Dikmen, Prof. Dr. study director
Sakarya Applied Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Support Program Based on a Nurse-Led Case Management Model in people with Caregiver Burnout, run by Sakarya University at 1 site in Turkey (Türkiye).
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 9 inclusion and 2 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: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in caregiver burden in 6 months (time frame: 6 months). 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 15 Sep 2022.