The Effect of Health Promotion Comprehensive Education Intervention on the Frailty Levels of Elderly Family Caregivers

NCT06064227 | Completed DMC

• 1 other identifier: 3207340744
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty; Caregiver Burden; Frail Elderly Syndrome

Keywords

elderly; frailty; caregiver family members; health promotion; training intervention

Outcome Measures

Primary Outcomes (1)

• 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. 1. 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) 2. 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)? 3. 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) 4. 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) 5. Total Weight Loss within 1 year (≥5% weight loss: 1, \<5% weight loss: 0)

  baseline ( before intervention) and 6 months after intervention

Study Arms (2)

intervention group.

EXPERIMENTAL

Multi-module training intervention. The intervention group, patients identified as pre-frail or frail, will be included in a multi-module educational program created specifically for this study.

Other: training intervention

control group

NO INTERVENTION

The control group will be selected by single-blind, stratified randomization (coin-flip) from among patients identified as pre-frail or frail and will not receive any intervention.

Interventions

training intervention OTHER

In this experimental study, the subject matter and sessions of the educational intervention, the effect of which was tested, were prepared based on evidence on preventable risk factors through health behavior change. The educational intervention consists of the following topics: Nutrition and physical exercise, chronic disease management and polypharmacy, anti-smoking and stress management, preventive health services, access to health screenings and immunization.

intervention group.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Providing care services for less than six months
• Failure to participate in one of the training modules or withdrawal from the study

Sponsors & Collaborators

• Fatma Banu Demirdas: lead

Study Sites (1)

Akdeniz University

Antalya, 07058, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 25161263 BACKGROUND

• 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.

  PMID: 35782680 BACKGROUND

• 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.

  PMID: 26524721 BACKGROUND

• 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.

  PMID: 29689126 BACKGROUND

• Mendis, Shanthi, et al. Global atlas on cardiovascular disease prevention and control. World Health Organization, 2011.

  BACKGROUND

• Pender, N.J.; Murdaugh, C.L.; Parsons, M. Health Promotion in Nursing Practice, 6th ed.; Pearso: Boston, MA, USA, 2011; pp. 122-126.

  BACKGROUND

• 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.

  PMID: 16505261 BACKGROUND

• 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.

  PMID: 19276189 BACKGROUND

• 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.

  PMID: 21093718 BACKGROUND

• 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.

  PMID: 26921655 BACKGROUND

MeSH Terms

Conditions

Frailty; Caregiver Burden

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Fatma Banu Demirdaş

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: October 3, 2023
• Study Start: June 15, 2023
• Primary Completion: July 15, 2023
• Study Completion: September 10, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)