Clinical trial NCT05754398: A Nurse-led Intervention on Frailty Status of Ethiopian Older Persons
Official title: Measuring the Effects of a Nurse-led Intervention on Frailty Status of Older Persons Living in the Community in Ethiopia: A Protocol for a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: Nurse-led
Intervention
Frailty
Elderly
Ethiopia
Lead sponsor: University of Wollongong
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 68
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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. 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. Effects of a nurse-led intervention improve the quality of life among the older persons living in the community of Bahir Dar, Ethiopia.

The nurse-led intervention consists of six independent interconnected education sessions focused on specific topic areas consisting of ageing and age-related changes, healthy nutrition, physical activity, mental health, social interaction, and support, and lastly an overall discussion on the intervention. The intervention is delivered one-on-one and face-to-face to the family homes of older people living in the community by specialist nurses who are community health workers (CHWs). 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.

Detailed description: The intervention consists of six independent interconnected education sessions focused on specific topic areas: ageing and age-related changes, healthy nutrition, physical activity, mental health, social interaction and support, and overall discussion.

A specialist community nurses will deliver the intervention. In each session, the nurse will describe the education, including its learning objectives, ask leading questions of the start of each session, and at the end of each session the participants will be provided with a simple take-home message on the specific topic discussed. The participants will have the opportunity to reflect on ideas, ask questions and discuss with the nurses delivering the intervention.

Session 1: Ageing and age-related changes

* Age and age-related changes,
* Sensory and perceptual changes on older persons
* Other changes that may happen in later life Session 2: Healthy nutrition
* Healthy diet for older persons
* Factors that cause nutritional problems in older persons
* Nutritional needs of older persons Session 3: Physical activity
* The need for physical activity for an older person
* The types of exercises that older people need to do
* How older people initiate exercise in a safe way Session 4: Mental health
* Ageing and mental health
* Factors for mental health problems in older persons
* Strategies to improve mental well-being in older persons Session 5: Social interaction and support
* The need for social participation and support
* The Risks of Senior Isolation Session 6: Overall discussion session
* This is the last session focused on an overall discussion and reflection with each study participant about the previous sessions.
* Discussion will also be made on how the study participants will sustain and implement the intervention in their day-to-day activities in their future life. 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.

The six sessions will be delivered over six consecutive months with each monthly session focusing consecutively on each the specific intervention topics. Each session will last approximately 30 to 40 minutes.

The intervention will be delivered by two community health workers (CHWs) under the supervision and support of the nursing Ph.D. candidate leading this study.

All six sessions will be delivered one-on-one and face-to-face in the home of the participants. 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.

At the end of each education session, participants will be provided with a simple but relevant take-home message about the specific session topic. At the end of each session the CHW will be required to reflect on how each participant undertakes their take-home message and commence the subsequent education session from the reflection. If a participant asks questions beyond the scope of the intervention material, depending on the nature of the question, they will be advised to meet with a medical expert at a nearby healthcare facility.

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. The study construct of the Nurse-led Intervention (NLI) is indicated below.

CHWs are registered nurses employed by the local government and work closely with the local community home-to-home and at health posts. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Change in frailty status of community-dwelling older persons.
timeFrame: 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:
measure: Change in the activity of daily living of community-dwelling older persons.
timeFrame: 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
measure: Change in the nutritional status of community-dwelling older persons.
timeFrame: Change in nutritional status will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
measure: Change in the level of depression
timeFrame: Changes in depression status will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
measure: Change in quality of life
timeFrame: Changes in quality of life will be measuredat baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
measure: Change in height
timeFrame: Changes in height will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
measure: Change in weight
timeFrame: Changes in weight will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
measure: Change in Calf Circumference (CC)
timeFrame: Changes in calf circumference will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
measure: Change in Body Mass Index (BMI)
timeFrame: Changes in Body Mass Index (BMI) will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
Other outcomes:
Locations:
city: Bahir Dar
country: Ethiopia
facility: Bahir Dar University
state: Amhara
Study officials:
affiliation: University of Wollongong
name: Victoria Traynor, Professor
role: STUDY_DIRECTOR
affiliation: University of Wollongong
name: Peta Drury, PhD
role: STUDY_CHAIR
affiliation: Taipei Medical University
name: Shu-Chun Lee, PhD
role: STUDY_CHAIR
affiliation: University of Wollongong
name: Hui-Chen (Rita) Chang, PhD
role: STUDY_CHAIR
References: