A Nurse-led Intervention on Frailty Status of Ethiopian Older Persons

NCT05754398 | Completed DMC

• 1 other identifier: 2022/212
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are to design, implement, and evaluate the effects of a nurse-led intervention on the frailty and quality of life of older persons living in the community in Ethiopia. The main hypothesis aims to test the following:

1. 1.Effects of a nurse-led intervention on frailty, including physical, social, and psychological domains of older persons living in the community in Bahir Dar, Ethiopia.
2. 2.Effects of a nurse-led intervention improve the quality of life among the older persons living in the community of Bahir Dar, Ethiopia.

Conditions

Frailty

Keywords

Nurse-led; Intervention; Frailty; Elderly; Ethiopia

Outcome Measures

Primary Outcomes (1)

• Change in frailty status of community-dwelling older persons.

  Changes in frailty will be measured using the Tilburg Frailty Indicator (TFI). The TFI comprises 15 self-reported questions, divided into three distinct domains. The physical, psychological, and social domains are the three distinct domains that constitute the TFI. The physical domain consists of eight questions related to different physical health of older persons. The psychological domain contains four items related to the psychological health of older persons. The last domain, the social domain has three questions related to social relations. Eleven items of the TFI have two response categories as "yes" or "no" options, while three items from the psychological domain and one item from the social domain have three response categories as "yes", "no," or "sometimes". The instrument's total score ranges from 0 to 15: the higher the score, the higher one's frailty. Frailty is diagnosed when the total TFI score is ≥5.

  Change in frailty will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention

Secondary Outcomes (8)

• Change in the activity of daily living of community-dwelling older persons.

  Changes in activity of daily living will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention

• Change in the nutritional status of community-dwelling older persons.

  Change in nutritional status will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention

• Change in the level of depression

  Changes in depression status will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention

• Change in quality of life

  Changes in quality of life will be measuredat baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention

• Change in height

  Changes in height will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention

Study Arms (1)

Single group will receive the nurse-led intervention

OTHER

A single group of community-dwelling older persons will receive a nurse-led intervention after an initial screening and eligibility checks.

Behavioral: six independent and interconnected educational training sessions

Interventions

six independent and interconnected educational training sessions BEHAVIORAL

Each of the six components will be offered each month for six consecutive months. Each session will last approximately 30 to 40 minutes. All the six sessions will be delivered through a face-to-face approach.

Single group will receive the nurse-led intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In Ethiopia, the cut points of old age started at 60 years.
• Older persons aged 60 years or above.
• Older persons whose frailty score is ≥ 5 as measured by the Tilburg Frailty Indicator (TFI).
• Older persons residing in Bahir Dar, Ethiopia.

You may not qualify if:

• Older persons who:
• are unable to communicate.
• have a cognitive impairment.
• are bed-redden.
• are not living at home.
• have been hospitalised with a known psychiatric problem within the past six months, and
• will not remain in the selected area during the study period.

Sponsors & Collaborators

• University of Wollongong: lead

Study Sites (1)

Bahir Dar University

Bahir Dar, Amhara, Ethiopia

Location

Related Publications (2)

• Kasa AS, Traynor V, Drury P. Measuring the effects of nurse-led frailty intervention on community-dwelling older people in Ethiopia: a quasi-experimental study. BMC Geriatr. 2024 Apr 30;24(1):384. doi: 10.1186/s12877-024-04909-2.

  PMID: 38689218 DERIVED

• Kasa AS, Drury P, Chang HR, Lee SC, Traynor V. Measuring the effects of a nurse-led intervention on frailty status of older people living in the community in Ethiopia: A protocol for a quasi-experimental study. PLoS One. 2024 Jan 19;19(1):e0296166. doi: 10.1371/journal.pone.0296166. eCollection 2024.

  PMID: 38241265 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Victoria Traynor, Professor

  University of Wollongong

  STUDY DIRECTOR

• Peta Drury, PhD

  University of Wollongong

  STUDY CHAIR

• Shu-Chun Lee, PhD

  Taipei Medical University

  STUDY CHAIR

• Hui-Chen (Rita) Chang, PhD

  University of Wollongong

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The data will be collected through a face-to-face administered structured survey questionnaire, and anthropometrical physical measurements. To reduce assessor bias, CHWs will not be involved in the data collection process. Hence, two professional nurses from Bahir Dar city will be recruited for data collection. The data collectors will not be involved in providing the intervention.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single-group pre-, post-, and follow-up single-group quasi-experimental study design will be adopted to examine the effect of a nurse-led intervention on frailty among older persons living in Bahir Dar City, Ethiopia.

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 3, 2023
• Study Start: January 3, 2023
• Primary Completion: June 20, 2023
• Study Completion: September 19, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The time frame will start from the time when summary data are published or start 6 months after publication.
• Access Criteria: IPD and additional supporting data information will be shared with scientific communities, readers, and other interested bodies through open-access journals.

Locations

ET (1)