A Nurse-led Intervention to Decrease Frailty Status of Ethiopian Older Persons

Sponsor
University of Wollongong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05754398
Collaborator
(none)
68
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1
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Study Details

Study Description

Brief Summary

The goal of this study is to design, implement, and evaluate a nurse-led intervention to decrease frailty of older persons in Ethiopia. The main hypothesis aims to test:

  1. The nurse-led intervention decreases frailty including the physical, social, and psychological domains among the older persons living in the community in Bahir Dar, Ethiopia.

  2. The nurse-led intervention improves the quality of life among the older persons living in the community in Bahir Dar, Ethiopia.

Study participants are required to take part in six independent and interconnected educational intervention sessions focussing on Ageing and age-related changes, healthy nutrition, physical activity, mental health, social interaction, and support, and lastly an overall discussion on the intervention.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: six independent and interconnected educational training sessions
N/A

Detailed Description

The intervention comprises six independent and interconnected educational training sessions on:

Ageing and age-related changes, healthy nutrition, physical activity, mental health, social interaction and support, and overall discussion.

In each session, the intervention providers will describe the training with learning objectives prior to the training, ask leading questions of the session, and at the end of each session study participants will be given a simple take-home message. Moreover, the study participants will have the opportunity to reflect on ideas, ask questions and discuss with the intervention providers.

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.

Each of the six components will be offered each month for six consecutive months. Each session will last approximately 30 to 40 minutes.

All six sessions will be delivered through a face-to-face approach. In the intervention period, there will be also a fortnightly 5 to 10-minute follow-up phone call with study participants to get feedback on their training or to provide counseling (Figure 3).

Study participants will be offered a home-based intervention by two Community Health Workers (CHWs) with close supervision and support from a Ph.D. candidate in nursing. At the end of each educational session, study participants will be provided with a simple but relevant take-home message. At the next session, after reflecting on how the participants undertook their take-home message the new educational session of the day will begin. 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 lost to follow-up (LTFU), and increase their adherence to implementing training content, 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 who are local government employees and work closely with the local community home-to-home and at health posts. CHWs know the culture, lifestyle, and norms of the community and they provide culturally appropriate health education and information, help people get the care they need, counsel and guide on health behaviours, and for the health needs of individuals and communities.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
The Effect of a Nurse-led Intervention to Decrease Frailty Status of Ethiopian Older Persons: A Protocol for a Quasi-experimental Study
Actual Study Start Date :
Jan 3, 2023
Anticipated Primary Completion Date :
Jun 18, 2023
Anticipated Study Completion Date :
Sep 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Single group will receive the nurse-led intervention

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
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.

Outcome Measures

Primary Outcome Measures

  1. Change in frailty status of community-dwelling older persons. [Change in frailty will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention]

    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.

Secondary Outcome Measures

  1. 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]

    The activity of daily living will be measured using the Katz Index of Independence in Activities of Daily Living. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. The responses are scored as a 'Yes' or 'No' for independence in each of the six functions. The minimum and maximum scores are 0 (zero) and 6 (six) respectively. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.

  2. 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]

    Changes in nutritional status will be measured using the Mini-Nutritional Assessment (MNA) tool. The MNA score ranges from 0 to 30. A higher score indicates a better nutritional status. Moreover, based on the MNA score, the nutritional status of older persons will be classified as: Malnourished (MNA Score <17), At risk of malnutrition (MNA Score 17 to 23.5) or Normal nutritional status (MNA Score 24 to 30).

  3. 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]

    The Geriatric Depression rating Scale-15 (GDS-15) will be used to measure the changes in depression. The values range from 0 to 15: the higher the score, the higher one's depression. Depression is considered using a cutoff point greater than or equal to five. The outcome will be coded depending on the cutoff point 0 to 4 as normal, 5 to 8 as mild depression, 9 to 11 as moderate depression, and 12 to 15 as severe depression

  4. 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]

    World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) will be used to measure the changes in quality of life of older persons. WHOQOL-BREF is a self-report questionnaire or interviewer-administered which contains 26 questions categorized into four domains that are scored on a 5-point Likert scale. The four domains are physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Values will be transformed into scores ranging from 0 to 100 according to the WHO guidelines. The higher the score the higher the quality of life. Two (question number 1 and 2) items measure the overall QOL and general health.

  5. 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]

    Change in height measurements will be taken without heavy outdoor clothing. Height will be measured using standard and caliber anthropometric rods in centimeters. In combination with the weight (in kg) of the study participant, the measured height then will be used to determine the Body Mass Index (BMI) of the study participant.

  6. Change in weight [Changes in weight will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention]

    Changes in weight will be measured on a pre-standardized body weighing scale in kilograms. In combination with the height (in m2) of the study participant, the measured weight then will be used to determine the Body Mass Index of the study participant.

  7. Change in Calf Circumference (CC) [Changes in calf circumference will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention]

    Calf Circumference (CC) will be measured using a tape meter in millimeters. The study participant will sit on a chair and hold his/her bare foot down, holding the leg folded to 90 degrees. The circumference of the calf at its widest point will be measured, laying the tape on the skin without tightening. The measurement will be taken at more than one point to ensure the measurement is taken at the widest part. An increased CC is associated with good nutrition status in older persons as measured in MNA.

  8. Change in Body Mass Index (BMI) [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]

    Height & weight measures will be aggregated to report Body Mass Index (BMI) as Weight measured in kilograms divided by height in meter square i.e [ Weight (kg)/Height (m2)]. An increased BMI is associated with increased nutrition status in older persons.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bahir Dar University Bahir Dar Amhara Ethiopia

Sponsors and Collaborators

  • University of Wollongong

Investigators

  • Study Chair: Victoria Traynor, Professor, University of Wollongong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ayele Semachew Kasa, Principal Investigator, University of Wollongong
ClinicalTrials.gov Identifier:
NCT05754398
Other Study ID Numbers:
  • 2022/212
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ayele Semachew Kasa, Principal Investigator, University of Wollongong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2023