Frailty Clinical Trial
Official title:
The Effect of Health Promotion Comprehensive Education Intervention on the Frailty Levels of Elderly Family Caregivers
Verified date | September 2023 |
Source | Akdeniz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was conducted to evaluate the effect of a comprehensive health promotion educational intervention applied to family caregivers over the age of 60 on their fragility levels. The main question(s) it aims to answer are: - Does the educational intervention have a significant impact on caregivers' vulnerability? - Does the educational intervention have a significant impact on caregivers' quality of life? The population of the study consists of family members who care for individuals receiving home health services in public hospitals in Antalya city center. G power test was used to determine the number of samples and the result of the analysis on the subject; Alpha value of 0.01 for independent sample t test at 95% confidence level; Taking an effect size of 1.35 and theoretical power of 99%, the minimum total sample size was determined as 58 people, 29 for each group. It was thought that it would be appropriate to take 30% more than the calculated minimum sample number due to possible losses that may occur during the research process, and as a result, it was decided to recruit 40 people for each group. In the study, the Participant Information Form developed by the researcher, the Health Promoting Lifestyle Profile (HPLP) scale, the frailty (FRAIL) scale and the World Health Organization quality of life scale for elderly individuals will be applied to family caregivers. SPSS statistical software package will be used in the analysis of the data obtained.
Status | Completed |
Enrollment | 88 |
Est. completion date | September 10, 2023 |
Est. primary completion date | July 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Being a volunteer - Providing care to individuals with a home health service application date longer than 6 months - Being able to speak and understand Turkish - Being 60 years of age or older - Having a kinship relationship with the individual they care for (mother, father, sibling, child, mother-in-law or father-in-law) Exclusion Criteria: - Providing care services for less than six months - Failure to participate in one of the training modules or withdrawal from the study |
Country | Name | City | State |
---|---|---|---|
Turkey | Akdeniz University | Antalya |
Lead Sponsor | Collaborator |
---|---|
Fatma Banu Demirdas |
Turkey,
Bhandari P, Kim M. Predictors of the Health-Promoting Behaviors of Nepalese Migrant Workers. J Nurs Res. 2016 Sep;24(3):232-9. doi: 10.1097/jnr.0000000000000120. — View Citation
Dassel KB, Carr DC. Does Dementia Caregiving Accelerate Frailty? Findings From the Health and Retirement Study. Gerontologist. 2016 Jun;56(3):444-50. doi: 10.1093/geront/gnu078. Epub 2014 Aug 26. — View Citation
Farrance C, Tsofliou F, Clark C. Adherence to community based group exercise interventions for older people: A mixed-methods systematic review. Prev Med. 2016 Jun;87:155-166. doi: 10.1016/j.ypmed.2016.02.037. Epub 2016 Feb 24. — View Citation
Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23. doi: 10.1001/archinte.166.4.418. — View Citation
Hepburn M. The Variables Associated With Health Promotion Behaviors Among Urban Black Women. J Nurs Scholarsh. 2018 Jul;50(4):353-366. doi: 10.1111/jnu.12387. Epub 2018 Apr 24. — View Citation
Kwak D, Thompson LV. Frailty: Past, present, and future? Sports Med Health Sci. 2020 Nov 30;3(1):1-10. doi: 10.1016/j.smhs.2020.11.005. eCollection 2021 Mar. — View Citation
Mendis, Shanthi, et al. Global atlas on cardiovascular disease prevention and control. World Health Organization, 2011.
Pender, N.J.; Murdaugh, C.L.; Parsons, M. Health Promotion in Nursing Practice, 6th ed.; Pearso: Boston, MA, USA, 2011; pp. 122-126.
Santos-Eggimann B, Cuenoud P, Spagnoli J, Junod J. Prevalence of frailty in middle-aged and older community-dwelling Europeans living in 10 countries. J Gerontol A Biol Sci Med Sci. 2009 Jun;64(6):675-81. doi: 10.1093/gerona/glp012. Epub 2009 Mar 10. — View Citation
Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in total frailty score 6 months after the first educational intervention | It consists of the sum of the scores corresponding to the participant's answers to the FRAIL scale questions.
Fatigue: How much of the last 4 weeks have you felt tired? 1=Always 2=Most of the time 3=Some of the time 4=Very little of the time 5=Never (1 point if the answer is 1 or 2, 0 points for the others) Resistance: Do you have difficulty climbing 10 stairs on your own and without using an assistive device and without resting (yes: 1 point, no: 0 points)? Ambulation: "Do you have difficulty walking a few hundred meters on your own and without using an assistive device?" (1 point if yes, 0 points if no) Disease: "Has a doctor ever told you that you have the following diseases?" (Hypertension, diabetes, cancer, chronic lung disease, heart attack, congestive heart failure, angina, asthma, arthritis, stroke, kidney disease) (0-4 diseases=0 points, 5-11 diseases=1 point) Total Weight Loss within 1 year (=5% weight loss: 1, <5% weight loss: 0) |
baseline ( before intervention) and 6 months after intervention |
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