FrailtyNCT05754398
A Nurse-led Intervention on Frailty Status of Ethiopian Older Persons
A study testing six independent and interconnected educational training sessions in people with Frailty, run by University of Wollongong at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- six independent and interconnected educational training sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEthiopia
- Study dates
- 3 Jan 2023to 19 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- 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.
- 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.
Read the 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.
- Conditions
- Frailty
- Being tested
- six independent and interconnected educational training sessions
- Keywords
- Nurse-led, Intervention, Frailty, Elderly, Ethiopia
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
six independent and interconnected educational training sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: six independent and interconnected educational training sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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 weight
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.
Measured: Changes in weight will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
Change in Calf Circumference (CC)
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.
Measured: Changes in calf circumference will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
Change in Body Mass Index (BMI)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start3 Jan 2023
- Primary completion20 Jun 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wollongong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayele Semachew Kasa, University of Wollongong
- Investigators
- Victoria Traynor, Professor, Study director, University of WollongongPeta Drury, PhD, Study chair, University of WollongongShu-Chun Lee, PhD, Study chair, Taipei Medical UniversityHui-Chen (Rita) Chang, PhD, Study chair, University of Wollongong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754398
- Sponsor's protocol ID
- 2022/212
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Publications
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.
PubMed 38689218Kasa 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.
PubMed 38241265
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05754398
- Acronym / sponsor ID
- 2022/212
- Conditions
- Frailty
- Keywords
- Nurse-led, Intervention, Frailty, Elderly, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of WollongongUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single group will receive the nurse-led intervention | Other | Behavioral: six independent and interconnected educational training sessionsA single group of community-dwelling older persons will receive a nurse-led intervention after an initial screening and eligibility checks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| six independent and interconnected educational training sessionsEach 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. | Behavioural | Single group will receive the nurse-led intervention |
Primary outcome
Change in frailty status of community-dwelling older persons.
Time frame: 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.
8 secondary outcomes
Change in the activity of daily living of community-dwelling older persons.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 weight
Time frame: Changes in weight will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
Change in Calf Circumference (CC)
Time frame: Changes in calf circumference will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention
Change in Body Mass Index (BMI)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Derived from this study: PubMed 38689218Kasa 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.
- Derived from this study: PubMed 38241265Kasa 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.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Traynor, Professor study director
University of Wollongong
Peta Drury, PhD study chair
University of Wollongong
Shu-Chun Lee, PhD study chair
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing six independent and interconnected educational training sessions in people with Frailty, run by University of Wollongong at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frailty status of community-dwelling older persons. (time frame: Change in frailty will be measured at baseline (before intervention) (T0), immediately after the intervention (T1) and at twelfth week of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05754398, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.