Caregiver BurdenNCT05277467
Elderly Urinary Incontinence Caregiver Burden
An observational study of Caregiver Burden and Urinary Incontinence, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the severity of urinary incontinence (UI) in elderly patients and its impact on the burden of care in their family caregivers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Caregiver Burden, Urinary Incontinence
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 30 Dec 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study was conducted prospectively with 80 elderly (≥65 years of age) patients with UI and their family caregivers who applied to the urology clinic of a state hospital between June and December 2021 and who have agreed to the study.
Who may be able to join
- The primary caregiver family member (mother, father, spouse, sibling, child), appropriate cognitive and mental health to respond to the applied forms, constant patient care
- The patient's being 65 years and older and diagnosed with urinary incontinence.
Who cannot join
- The family member who did not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urinary Incontinence in Elderly Patients and Its Impact on Caregiver Burden: An Overlooked and Underestimated Topic
The purpose of this study is to evaluate the severity of urinary incontinence (UI) in elderly patients and its impact on the burden of care in their family caregivers.
Read the detailed description
The objective was to evaluate the severity of urinary incontinence (UI) in elderly patients and its impact on the burden of care in their family caregivers.
The study is a descriptive, cross-sectional and relationship-seeking type of research. It was conducted prospectively with 80 elderly(≥65 years of age) patients with UI and their family caregivers who applied to the urology clinic between June and December 2021. The data was collected using the "Socio-Demographic Characteristics Data Collection Form". UI was assessed by "International Consultation on Incontinence Questionnaire Short Form(ICIQ-UI-SF)" and caregiver burden by means of Zarit Burden Scale(ZBI) form.
- Conditions
- Caregiver Burden, Urinary Incontinence
- Being tested
- no intervention
- Keywords
- urinary incontinence, elderly patient, family member, caregiver, caregiver burden
- Medical subject headings
- Caregiver Burden, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire Short Form
It is a reliable and useful form developed to examine the effect of UI on quality of life. There are questions on the scale that include evaluating the effect of UI on frequency, amount, causes and burden of care. The scale is of likert type and consists of four dimensions. The first dimension includes the frequency of the UI, the second dimension the amount of the UI, the third dimension the impact of the UI on daily life, and the fourth dimension the situations that cause the UI. The maximum score that can be obtained from the scale is 21, and 8 points and above define the UI that causes discomfort.
Measured: This form was applied to the patients immediately after the patient examination at the urology clinic.
Zarit Burden Interview
The caregiving burden scale was used to evaluate the difficulty of providing care experienced by caregivers. 0-20 points from the scale indicate "never a burden of care'', 21-40 points indicate "burden of care rarely'', 41-60 points indicate "burden of care quite frequently'' and 61-88 points indicate "burden of care nearly always''.
Measured: This form was applied to the patients immediately after the patient examination at the urology clinic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Jun 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURSEMIN UNAL, Ankara Medipol University
- Investigators
- Nilay BEKTAS AKPINAR, PhD, Principal investigator, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277467
- Sponsor's protocol ID
- 22
- Status last verified
- Mar 2022
- First submitted
- 1 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eifert EK, Adams R, Dudley W, Perko M. Family caregiver identity: A literature review. American Journal of Health Education. 2015;46(6):357-67.
D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.
PubMed 30681183Talley KMC, Davis NJ, Peden-McAlpine C, Martin CL, Weinfurter EV, Wyman JF. Navigating through incontinence: A qualitative systematic review and meta-aggregation of the experiences of family caregivers. Int J Nurs Stud. 2021 Nov;123:104062. doi: 10.1016/j.ijnurstu.2021.104062. Epub 2021 Aug 13.
PubMed 34461378Yang E, Lisha NE, Walter L, Obedin-Maliver J, Huang AJ. Urinary Incontinence in a National Cohort of Older Women: Implications for Caregiving and Care Dependence. J Womens Health (Larchmt). 2018 Sep;27(9):1097-1103. doi: 10.1089/jwh.2017.6891. Epub 2018 Jun 14.
PubMed 29902123Yenisehir S, Citak Karakaya I, Karakaya MG. Knowledge and practice of nursing home caregivers about urinary incontinence. Eur Geriatr Med. 2019 Feb;10(1):99-105. doi: 10.1007/s41999-018-0129-0. Epub 2018 Nov 13.
PubMed 32720273Di Rosa M, Lamura G. The impact of incontinence management on informal caregivers' quality of life. Aging Clin Exp Res. 2016 Feb;28(1):89-97. doi: 10.1007/s40520-015-0367-7. Epub 2015 May 10.
PubMed 25957737Davis NJ, Parker VG, Lanham J, Love CR, Christy MR, Poetzschke E, Wyman JF. Burdens and Educational Needs of Informal Caregivers of Older Adults With Urinary Incontinence: An Internet-Based Study. Rehabil Nurs. 2021 May-Jun 01;46(3):172-178. doi: 10.1097/rnj.0000000000000317.
PubMed 33591086
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Incontinence in Elderly Patients and Its Impact on Caregiver Burden: An Overlooked and Underestimated Topic
- ClinicalTrials.gov ID
- NCT05277467
- Acronym / sponsor ID
- 22
- Conditions
- Caregiver Burden, Urinary Incontinence
- Keywords
- urinary incontinence, elderly patient, family member, caregiver, caregiver burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 14 Mar 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 evaluate the severity of urinary incontinence (UI) in elderly patients and its impact on the burden of care in their family caregivers.
Detailed description
The objective was to evaluate the severity of urinary incontinence (UI) in elderly patients and its impact on the burden of care in their family caregivers.
The study is a descriptive, cross-sectional and relationship-seeking type of research. It was conducted prospectively with 80 elderly(≥65 years of age) patients with UI and their family caregivers who applied to the urology clinic between June and December 2021. The data was collected using the "Socio-Demographic Characteristics Data Collection Form". UI was assessed by "International Consultation on Incontinence Questionnaire Short Form(ICIQ-UI-SF)" and caregiver burden by means of Zarit Burden Scale(ZBI) form.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study was conducted prospectively with 80 elderly (≥65 years of age) patients with UI and their family caregivers who applied to the urology clinic of a state hospital between June and December 2021 and who have agreed to the study.
Key inclusion criteria (2 listed)
- The primary caregiver family member (mother, father, spouse, sibling, child), appropriate cognitive and mental health to respond to the applied forms, constant patient care
- The patient's being 65 years and older and diagnosed with urinary incontinence.
Key exclusion criteria (1 listed)
- The family member who did not volunteer to participate in the study
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
International Consultation on Incontinence Questionnaire Short Form
Time frame: This form was applied to the patients immediately after the patient examination at the urology clinic.
It is a reliable and useful form developed to examine the effect of UI on quality of life. There are questions on the scale that include evaluating the effect of UI on frequency, amount, causes and burden of care. The scale is of likert type and consists of four dimensions. The first dimension includes the frequency of the UI, the second dimension the amount of the UI, the third dimension the impact of the UI on daily life, and the fourth dimension the situations that cause the UI. The maximum score that can be obtained from the scale is 21, and 8 points and above define the UI that causes discomfort.
Zarit Burden Interview
Time frame: This form was applied to the patients immediately after the patient examination at the urology clinic.
The caregiving burden scale was used to evaluate the difficulty of providing care experienced by caregivers. 0-20 points from the scale indicate "never a burden of care'', 21-40 points indicate "burden of care rarely'', 41-60 points indicate "burden of care quite frequently'' and 61-88 points indicate "burden of care nearly always''.
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 14 Mar 2022.
- BackgroundEifert EK, Adams R, Dudley W, Perko M. Family caregiver identity: A literature review. American Journal of Health Education. 2015;46(6):357-67.
- Background: PubMed 30681183D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.
- Results publication: PubMed 34461378Talley KMC, Davis NJ, Peden-McAlpine C, Martin CL, Weinfurter EV, Wyman JF. Navigating through incontinence: A qualitative systematic review and meta-aggregation of the experiences of family caregivers. Int J Nurs Stud. 2021 Nov;123:104062. doi: 10.1016/j.ijnurstu.2021.104062. Epub 2021 Aug 13.
- Results publication: PubMed 29902123Yang E, Lisha NE, Walter L, Obedin-Maliver J, Huang AJ. Urinary Incontinence in a National Cohort of Older Women: Implications for Caregiving and Care Dependence. J Womens Health (Larchmt). 2018 Sep;27(9):1097-1103. doi: 10.1089/jwh.2017.6891. Epub 2018 Jun 14.
- Results publication: PubMed 32720273Yenisehir S, Citak Karakaya I, Karakaya MG. Knowledge and practice of nursing home caregivers about urinary incontinence. Eur Geriatr Med. 2019 Feb;10(1):99-105. doi: 10.1007/s41999-018-0129-0. Epub 2018 Nov 13.
- Results publication: PubMed 25957737Di Rosa M, Lamura G. The impact of incontinence management on informal caregivers' quality of life. Aging Clin Exp Res. 2016 Feb;28(1):89-97. doi: 10.1007/s40520-015-0367-7. Epub 2015 May 10.
- Results publication: PubMed 33591086Davis NJ, Parker VG, Lanham J, Love CR, Christy MR, Poetzschke E, Wyman JF. Burdens and Educational Needs of Informal Caregivers of Older Adults With Urinary Incontinence: An Internet-Based Study. Rehabil Nurs. 2021 May-Jun 01;46(3):172-178. doi: 10.1097/rnj.0000000000000317.
- Individual participant dataSharing planned: No
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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.
Nilay BEKTAS AKPINAR, PhD principal investigator
Ankara Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver Burden and Urinary Incontinence, run by Ankara Medipol 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 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: finished, as of the sponsor's last update on 14 Mar 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?
International Consultation on Incontinence Questionnaire Short Form (time frame: This form was applied to the patients immediately after the patient examination at the urology clinic.). 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?
On the ClinicalTrials.gov record for NCT05277467, which also lists 7 linked publications.
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 14 Mar 2022.