https://orcid.org/0000-0003-3320-8329
Figures
Abstract
Background
The recent recognition of the multidimensional features of frailty has emphasised the need for individualised multicomponent interventions. In the context of sub-Saharan Africa, few studies have examined: a) the frailty status of the older population; b) the level of frailty and its health implications and; c) the impact of a nurse-led intervention to reduce frailty.
Objectives
This study aims to design, implement, and evaluate a nurse-led intervention to reduce frailty and associated health consequences among older people living in Ethiopia.
Methods
The study will be conducted on 68 older persons using a pre-, post-, and follow-up single-group quasi-experimental design. Residents of Ethiopia, ≥60 years and living in the community will be invited to participate in a 24-week program designed to decrease frailty and associated health consequences. Data will be collected at three-time points: baseline, immediately after the intervention, and 12 weeks post-intervention. To determine the effect of the intervention, changes in frailty, nutritional status, activities of daily living, depression and quality of life scores will be measured. To measure the effect of a nurse-led intervention on the level of frailty among older people a generalised linear model (GLM) using repeated measures ANOVA will be used. Statistical significances will be set at p-values < 0.05.
Discussion
The results of this study will determine the impact of a nurse-led intervention to reduce frailty amongst community-dwelling older people living in Ethiopia. The results of this study will inform the development of future interventions designed to reduce frailty in lower-income countries.
Trial registration
The trial was registered in ClinicalTrials.gov with the identifier of NCT05754398.
Citation: Kasa AS, Drury P, Chang H-C(, Lee S-C, Traynor V (2024) 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 19(1): e0296166. https://doi.org/10.1371/journal.pone.0296166
Editor: Azmeraw Ambachew Kebede, University of Gondar College of Medicine and Health Sciences, ETHIOPIA
Received: July 8, 2023; Accepted: December 5, 2023; Published: January 19, 2024
Copyright: © 2024 Kasa et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.
Funding: This work was supported by the Australian Government Research Training Program Scholarship in the form of University Postgraduate Award (UPA) as a student stipend. The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: This study was funded in part by the Australian Government Research Training Program Scholarship in the form of University Postgraduate Award (UPA) as a student stipend. No additional external funding was received for this study.
Abbreviations: CHWs, Community Health Workers; HICs, High-Income Countries; ICMF, Integral Conceptual Model of Frailty; LICs, Low-Income Countries; LMICs, Lower Middle-income Countries; QOL, Quality of life; SSA, sub–Saharan Africa; TFI, Tilburg Frailty Indicator; UOW, University of Wollongong; WHO, World Health Organization
Background
In the upcoming decades, the ageing population will become a significant demographic phenomenon worldwide [1]. The elderly population in sub-Saharan Africa (SSA) is projected to double from approximately 34 million in 2005 to 67 million by 2030. SSA is experiencing a faster growth in the number of older individuals compared to developed countries, and this pattern is expected to persist [1–3]. Among SSA countries, Ethiopia ranks second in terms of the largest population of individuals aged 60 and above, following Nigeria [4]. The escalating challenges of malnutrition and non-communicable diseases, along with limited healthcare access and inadequate living conditions for older individuals in Ethiopia [5, 6], contribute to the state of frailty.
Frailty is a multidimensional geriatric syndrome that refers to a condition in which there is a decline in physical, cognitive, and psychological functioning [7, 8]. Frailty is often characterised by weakness, fatigue, unintended weight loss, slowed motor functioning, and decreased energy levels [9]. It can be caused by a combination of various factors, including age-related physiological changes, underlying health conditions, environmental factors, and lifestyle choices [10, 11]. Progressive declines in physical, mental, and social health are manifestations of frailty. These manifestations greatly affect older people’s well-being and quality of life (QOL) [12]. Physical, mental, cognitive, and social domains of functioning change with age. Accumulation of problems in one or more of these domains of functioning are the features of frail people [13]. Studies on older people revealed that physical frailty varies significantly and is more prevalent when psychological frailty is considered [14]. Across all domains of frailty, mobility, nutrition, and cognitive function were identified as the most frequently identified factors of frailty [15].
As frailty is a multifactorial health problem, prior studies have emphasised the need for individualised and multifactorial interventions [16]. Numerous high-quality studies using interventional designs emphasised the importance of multifactorial frailty interventions in older people and developed different frailty interventions. Majority of the studies found that physical, nutritional, and cognitive interventional approaches were effective in reversing frailty among community-dwelling older people [17–19]. These studies have emphasised the need for further studies to evaluate the effectiveness of frailty interventions in other settings [20–23] (Table 1).
Few studies have examined the effect of a nurse-led intervention to reduce frailty amongst community-dwelling older people [17, 22, 29]. Prior studies investigating the effect of interventions designed to reduce frailty have predominantly led by general practitioners and physiotherapists [25, 32, 33]. As frontline healthcare providers, nurses have frequent and direct contact with older persons and are in a unique position to identify health promotion needs and provide education, counseling, and support to improve health outcomes [34]. Nurses are trained to care for older persons with complex conditions that requires a holistic approach [35]. Nurse-led interventions have the potential to enhance health outcomes and alleviate the burden on acute hospital services for frail older individuals residing in the community [36].
A recent study in Ethiopia has identified 39% of community-dwelling older people were living with frailty [37]. Frailty impacts quality of life of older people and places additional demands on the healthcare system [38]. The majority of frail older person within Ethiopia are living in the community, where healthcare predominantly delivered by community nurses. Therefore, the aim of this study is to design, implement, and evaluate the effects of a nurse-led intervention on the frailty and quality of life of older people living in the community in Ethiopia.
Methods
Study hypothesis and design
The primary outcome is change in frailty status of community-dwelling older persons measured at three points in time: baseline (T0), immediately post-intervention (T1) and at 12 weeks post intervention (T2) using the Tilburg Frailty Indicator-Amharic Version (TFI-AM) [39]. We hypothesise that frail older people who received the nurse-led intervention will have a reduced frailty score, including the physical, psychological, and social domains of frailty. Secondary outcomes include changes in the activities of daily living as measured using the Katz Index of Independence in Activities of Daily Living [40], nutritional status using Mini-Nutritional Assessment (MNA) [41–43], Recent appetite using the Simplified Nutritional Appetite Questionnaire (SNAQ), level of depression using Geriatric Depression rating Scale-15 (GDS-15) [43–45] and quality of life using the World Health Organization’s QOL Questionnaire (WHOQOL-BREF) [46] measured at each data collection time points (Table 2).
The study will be conducted using a pre-, post-, and follow-up single group quasi-experimental design. A quasi-experimental design was chosen since randomising clients at these community programs for vulnerable older people would not be ethical or feasible (33–35).
This study will adhere to the Transparent Reporting of Evaluations with Nonrandomised Designs (TREND) guidelines [63]. This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting checklist [64]. The protocol was registered retrospectively three months after data collection commenced. The only amendment requested from the clinical trial review was to provide additional detail on the secondary outcome measures. This detail was provided and the trial was registered at ClinicalTrial.gov. The trial is being undertaken exactly as described in NCT05754398.
Setting
The study will be conducted in Bahir Dar, Ethiopia. Bahir Dar is the capital city of the regional state of Amhara, Ethiopia. Based on a survey conducted by Bahir Dar City Labour and Social Affairs Administration Office in 2018 revealed that there were over 3,300 older people in Bahir Dar City administration [65]. In Bahir Dar City, there are three public and four private hospitals, 10 health centers and 15 health posts. In the Ethiopian health tier system, health posts, health centres and primary hospitals are grouped under primary health care, whereas general hospitals and specialized hospitals are grouped as secondary and tertiary level healthcare respectively [66]. The health office of Bahir Dar city administration oversees all primary level healthcare facilities in the city administration [67].
Sample size
The study sample size was calculated using a priori computation of sample size using G* Power version 3.1.9.4 [68] with assumption of a two-tailed test with an alpha value of 0.05, effect size (f) of 0.5, and a power of 0.95. The power was set using a Wilcoxon signed-rank test based on normal parent distribution methods. Using this equation, we estimate that 57 participants will be recruited for this study. By considering a 10 to 20% [23, 29] withdrawal rate during the intervention, at least 68 study participants will be required.
Eligibility
Inclusion and exclusion criteria.
The year in which ‘old age’ commences is determined by a setting and the formal cutoff point legislated in social policy for each country [56]. In Ethiopia, the cutoff point for old age is 60 years [69, 70]. Therefore, older people 60 years or above, whose frailty score ≥ 5 as measured by the Tilburg Frailty Indicator Amharic Version (TFI-AM) [39] and residing in Bahir Dar, Ethiopia, will be included in the study. Participants will be excluded if they are unable to communicate, have major cognitive impairment, are bed-redden, do not live at home, have been hospitalised with a known psychiatric problem within the past six months, or will not reside in the selected area during the study period.
Recruitment.
A list of older people in the selected sub city will be obtained from the household’s registration which are listed with the city’s administration health office. Then, potential study participants will be recruited by the Community Health Workers (CHWs) using a convenience sampling method in home-to-home bases. During the home visit the CHW will explain the aim of the study, undertake a screen to determine frailty status, and obtain consent to participate in the intervention.
Each participant will undergo a baseline assessment before starting the nurse-led intervention after confirming eligibility, willingness, and receiving written informed consent. The baseline assessment will include socio-demographics, health-related factors, frailty, nutrition, depression, social support, activities of daily living, and quality of life. At the end, study participants who received all the nurse-led intervention sessions will be included in the final analysis to determine the effectiveness of the nurse-led intervention to reduce frailty among older people in Ethiopia.
Authors access to study participant information and confidentiality.
All information related to study participants will remain confidential and will be identifiable by codes known only to the researcher. Study participants’ involvement in the study is entirely voluntary and participants may choose to withdraw at any time.
Intervention
The design of the intervention has been guided by the Integral Conceptual Model of Frailty (ICMF) framework. This framework denotes that physical, psychological, and social domains of health are key components to ensure the health of frail older people [13, 71].
The Nurse-led Intervention (NLI) program comprises six distinct and interconnected education sessions including:
- Session 1 Ageing and age-related changes
- Session 2 Healthy nutrition
- Session 3 Physical activity
- Session 4 Mental health
- Session 5 Social interaction and support
- Session 6 Discussion and reflection (Fig 1):
R-S1: Reflection on session 1, R-S2: Reflection on session 2, R-S3: Reflection on session 3, R-S4: Reflection on session 4, R-S5: Overall discussion on all sessions, R-S6: Reflection on session SS: Social support.
The CHWs will deliver one face-to-face session per month to each participant in their home. Therefore, all six sessions will take six consecutive months to deliver. Each session will last approximately from 30 to 40 minutes. During the six months when the intervention is delivered, there will be a fortnightly 5 to 10-minute follow-up phone call with participants to receive feedback about the education sessions and provide opportunistic counseling on the specific topics. Each CHW will be trained by a PhD candidate in nursing. To reduce loss to follow-up (LTFU) and increase adherence rates to intervention, participants will be encouraged and reminded by phone to attend upcoming sessions (Table 3).
To promote adherence to the intervention, a nurse-led education intervention handbook contextually relevant to frailty management for older people will be developed. The content of the training handbook will be based on the multi-dimensional concept of frailty [15, 22, 72] and will be customised to the local setting. The training handbook will be accompanied by illustrative pictures. The training handbook will be reviewed by Ethiopian community nurses with experience in community health care services. The training handbook will be translated into the local language, Amharic, and reviewed by a bilingual expert from Bahir Dar University, Ethiopia. A booklet on frailty management education will be disseminated to the study participants during the first session of the nurse-led education. To promote ease of access to education sessions, the education sessions will be conducted at the participants’ own home. Each CHW will be provided with a notebook to record the progress of each participant undertaking the program and any questions that need to be followed up at a subsequent session.
Recruiting process of community health workers (CHWs) to deliver the intervention.
Discussion on the overall aims and procedures of the study was done with senior health facility administrators in the study area. Two senior health administrators from the zonal and health centre in Bahir Dar were contacted to discuss the details of the study objectives, and procedures to be followed. Further discussion made on recruiting potential CHWs that will be appropriate to deliver the intervention who have previous experience providing health promotional interventions. Moreover, when selecting the potential CHWs, the discussion also focused on communication, commitment to work, compassion, and professionalism.
Community Health Workers are registered nurses employed by the local government and work closely with the local community home-to-home and at health posts [73]. CHWs know the culture, lifestyle, and social norms of the community and provide culturally appropriate health education and information, help community members access the care they need, counsel and guide on health-promoting behaviours, and for the health needs of individuals and communities [74].
Before the intervention is initiated, two CHWs undergo training by the PhD candidate in nursing on the study aim, and procedure, exercise safety protocols, and how study participants be approached ethically. Moreover, an observational checklist has been used to assess the communication skill, compassion, and knowledge of the CHWs on the contents of the intervention. The intervention checklist has been prepared based on the contents of the six sessions of the intervention handbook.
Data collection
To reduce assessor bias, CHWs will not be involved in the data collection process. Two registered nurses from Bahir Dar city will be recruited for data collection. They will be required to attend a 2-day training workshop focused on data collection tools, and ethical consideration for the older person. Data will be collected in person through a face-to-face administered questionnaire. The following physical data will also be collected at the same time: height, weight, calf circumference and mid arm circumference. These parameters will assist in determining nutritional status in conjunction with the other items in the Mini-Nutritional Assessment (MNA) tool [41, 51, 75] Questionnaires will be administered to study participants at baseline (before the intervention) (T0), immediately after the intervention (T1) and at the 12 weeks of post intervention (T2) [29, 76, 77]. The structured questionnaire comprises nine different sections of which seven sections (Section III to IX) have been developed from validated tools (Table 2).
To measure adherence to the program the CHWs will maintain an attendance record. At the beginning of each session the CHWs will record attendance of the participants by checking off the name of a participant against each session in their notebook. Acceptability of the program from the perspectives of the CHWs will be recorded in two ways: (1) field notes written by the CHWs in the notebooks they used to while delivering the program and (2) at the end of the intervention. The informal discussions with the CHWs will also be used to generate feedback about the training handbook. Acceptability of the program from the perspectives of the participants will also be recorded at the end of the last session of the intervention.
Data analyses
The information collected through paper-based questionnaires will be inputted into EpiData Manager software and then exported to IBM SPSS 26.0 (IBM Corp., Armonk, NY, USA) for analysis. The correlation between frailty and various factors among older individuals will be assessed using Pearson correlation analysis. Numerical data will be summarised as mean (±SD), while categorical data will be presented and summarised using both frequencies and percentages. The normality of the data will be checked using a One-Sample Kolmogorov-Smirnov’s test. To evaluate the impact of the nurse-led intervention, a generalized linear model (GLM) with repeated measures ANOVA will be employed. If the data do not follow a normal distribution, the Friedman test will be utilised. Student’s t-test will be used to compare the level of frailty with categorical variables. Statistical significance will be determined using a p-value threshold of < 0.05.
Discussion
Frailty in older people is influenced by a wide range of physical, behavioural, and psychosocial health factors. The recent recognition of the multi-dimensional nature of frailty has highlighted the need for individualised multi-factorial interventions. Studies from developed countries have recognised the importance of frailty in older people and have developed several frailty interventions with positive outcomes from community settings. The proposed study is aimed to examine the effect of nurse-led intervention on frailty status among older people living in a low-income setting.
No prior studies have attempted to examine the effectiveness of nurse-led intervention designed to reduce the frailty status of older people in African. In resource-limited settings, there is limited focus on the healthcare of older people. This study aims to develop, implement and evaluate an intervention to reduce frailty in lower income settings. By conducting this research, we will contribute valuable knowledge to future researchers designing interventions to reduce frailty. Healthcare professionals, especially nurses who work in the community, will become familiar with screening tools for frailty. They will also have access to the interventional handbook developed by the researchers highlighting the six-month intervention and how to deliver it in the community.
This study will open the door for researchers and concerned government officials to consider the multidimensional healthcare needs of older people living in resource-limited settings.
Having a better understanding of older people who live in resource-limited settings will allow healthcare professionals, researchers, and government officials to consider the multidimensional healthcare needs of these group of population. The findings from this study will also contribute to frailty management strategies in reducing the adverse outcomes related to frailty and assisting in clinical decision-making.
Strengths of the study
- This study is the first nurse-led intervention designed to decrease frailty among older people in Ethiopia.
- The study will demonstrate alternatives on how the nurse-led intervention for older people with frailty can be integrated with the existing Ethiopian health extension package.
- Healthcare professionals, working in the community through home visiting will become familiar with the concept of frailty and associated health outcomes when assessing older people.
Limitations of the study
- At the start of each session the CHWs will ask the participants about their progress since the previous session, that is how they are incorporating the health information provided into their daily lives and will answer any questions from the participants about the previous session. However, no data collection tool was created to specifically record compliance with the health information provided in each of the sessions.
- The study will be time-consuming and with a relatively long follow-up, loss to follow-up may be an issue.
Supporting information
S1 Checklist. SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.
https://doi.org/10.1371/journal.pone.0296166.s001
(DOC)
S2 Checklist. PLOS ONE clinical studies checklist.
https://doi.org/10.1371/journal.pone.0296166.s002
(DOCX)
S1 File. Inclusivity in global research questionnaire ASK.
https://doi.org/10.1371/journal.pone.0296166.s003
(DOCX)
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