FrailtyNCT06205238
The Impact of Domiciliary Versus 'Hub' Based Comprehensive Geriatric Assessment on Clinical and Process Outcomes Among Older Adults Attending Community Specialist Teams: a Randomised Controlled Trial.
A study testing CGA in people with Frailty and Comprehensive Geriatric Assessment, run by University of Limerick at 1 site in Ireland.
Trial summary
The investigators plan to implement a randomised controlled trial to examine the impact of domiciliary (home based) versus 'hub-based' Comprehensive Geriatric Assessment (CGA) on clinical and process outcomes among older adults referred to a community specialist team for older persons in the Mid-West region of… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty, Comprehensive Geriatric Assessment, Older Adults
- What is being tested?
- CGA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteIreland
- Study dates
- 15 Jan 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Referred to the CST hub from a General Practitioner (urgent referral) or from the ED at University Hospital Limerick.
- All of criteria 1-5 must be met
- 75 years and over
- Evidence of frailty, scoring between 4 and 6 on the Rockwood Clinical Frailty Scale (pre-frail, mildly frail or moderately frail)
- Resides within CHO 3 and the catchment area of the relevant ICPOP hub
- Patient has been assessed in-person by the referrer
Show all 12Show fewer
- Patient has not had MDT input within the last three months (excluding OPTIMEND team)
- And any one of criteria 6-10 must be met:
- Fall within the last month unrelated to acute cardiac or neurological cause \& no previous falls assessment
- Increased dependency or increased carer burden in the last month
- A deterioration in swallow in the last month including symptoms of recurrent chest infections, weight loss, coughing when eating/drinking, self-modifying diet secondary to difficulties
- Adverse drug reaction within the last month excluding allergic reaction Referred from ED/AMU following review by consultant in Emergency Medicine, Acute Medicine, Geriatric Medicine, General Medicine or Frailty at the Front Door team
Who cannot join
- Present with an acute neurological or cardiovascular event
- Are more appropriate to an alternative care pathway or service e.g. primary care or geriatric medicine clinic
- Present with injuries, unless the injury has already been appropriately managed,
- Are experiencing an acute medical illness requiring treatment in an acute hospital setting
- If care is being provided by other health care professionals at the time of referral and it is apparent that they are working to meet goals aligned with the current service
- They require investigation or treatment not available in the relevant ICPOP hub (unless these investigations are already being arranged elsewhere)
Show all 9Show fewer
- They have had MDT input in the last three months
- Have confirmed or suspected Covid-19 infection
- Or other exclusions at the discretion of the integrated care team based on clinical expertise and available resource.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators plan to implement a randomised controlled trial to examine the impact of domiciliary (home based) versus 'hub-based' Comprehensive Geriatric Assessment (CGA) on clinical and process outcomes among older adults referred to a community specialist team for older persons in the Mid-West region of Ireland. The population of interest is older adults who are discharged directly from the Emergency Department or referred urgently from their General Practitioner. The outcomes of interest focus on those that matter most to older adults as well as clinical and process measures of care.
Read the detailed description
CGA is defined as a "multidimensional interdisciplinary diagnostic process focused on determining a frail elderly person's medical, psychological and functional capability in order to develop a coordinated and integrated plan for treatment and long term follow up" (1). The CST hub in Limerick provides a rapid, single point of access to an outpatient specialist geriatrician and allied health professional assessment. The bulk of this therapy is delivered in each of the hubs. This is considered 'usual' or routine care for the purposes of this trial.
The intervention will consist of domiciliary multidisciplinary CGA and intervention including nursing, medical and allied health assessment and intervention for frail older adults over age 75 who are discharged from the ED, or referred urgently from their General Practitioner and referred to the CST in Limerick. The bulk of this intervention will be delivered in the patient's own home. Each participant will be required to attend the hub for their medical review where they will access specialist geriatric medical expertise. A domiciliary visit to the older person within 24-48 hours of referral from the ED or within 24-48 hours of triage of GP referral by a member of the multidisciplinary team will be carried out. This person will act as the case coordinator for the duration of the intervention. During this visit, there will be a detailed assessment of the older adult. The assessment will include but not be limited to a falls assessment, assessment of mobility and stairs, transfer, personal care, activities of daily living (ADLs), social supports, cognition, lying \& standing blood pressures and nutritional assessment. Referrals will be made for domiciliary care to the appropriate healthcare professionals (nursing, OT, physiotherapy, dietetics etc) based on the findings of this holistic assessment. Interventions prescribed will be individualised based on patient needs. The investigators will use the template proposed by Ellis et al. (2017) to characterise the components of the CGA intervention.
The trial will assess the benefits of this domiciliary model of care on outcomes including the following: function, quality of life, patient satisfaction, primary and secondary healthcare use, nursing home admission, mortality and cost-effectiveness. Baseline measurement will be taken at their index visit with follow-up at six weeks and 6 months.
- Being tested
- CGA
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGAOther
CGA is defined as a "multidimensional interdisciplinary diagnostic process focused on determining a frail elderly person's medical, psychological and functional capability in order to develop a coordinated and integrated plan for treatment and long term follow up".
| Study group | Role | What they receive |
|---|---|---|
| Domiciliary CGA | Experimental | The intervention will consist of domiciliary CGA including nursing, medical and allied health assessment and intervention for frail older adults over age 75 who are discharged the ED or referred urgently from their GP and referred to the CST in Limerick. The bulk of this intervention will be delivered in the patient's own home. Each participant will be required to attend the hub for their medical review where they will access specialist geriatric medical expertise. A domiciliary visit to the older person within 24-48 hours of referral from the ED or within 24-48 hours of triage of GP referral by a member of the multidisciplinary team. This person will act as the case coordinator. During this visit, there will be a detailed assessment of the older adult. Referrals will be made for domiciliary care to the appropriate healthcare professionals based on patient. The template proposed by Ellis et al. (2017) will be used to characterise the components of the CGA intervention. Receives: Other: CGA |
| Hub-based CGA | Active comparator | The intervention will consist of CGA as defined above, including nursing, medical and allied health assessment and intervention for frail older adults over age 75 who are discharged the ED or referred urgently from their General Practitioner and referred to the CST in Limerick and will be seen in the Out-patient CST setting. Receives: Other: CGA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status
Barthel Index
Measured: Baseline
Functional status
Barthel Index
Measured: 6-weeks
Functional status
Barthel Index
Measured: 6-months
Functional status
Barthel Index
Measured: 12-months
Secondary outcomes (25)
Unplanned ED revisit
Process measure for hospital data base
Measured: Baseline
Unplanned ED revisit
Process measure for hospital data base
Measured: 6-weeks
Unplanned ED revisit
Process measure for hospital data base
Measured: 6-months
Unplanned hospitalisation
Process measure for hospital data base
Measured: Baseline
Unplanned hospitalisation
Process measure for hospital data base
Measured: 6-weeks
Unplanned hospitalisation
Process measure for hospital data base
Measured: 6-months
Nursing Home admission
Process measure
Measured: 6-weeks
Nursing Home admission
Process measure
Measured: 6-months
Mortality
The number of participants who died following their index visit
Measured: 6-weeks
Mortality
The number of participants who died following their index visit
Measured: 6-months
Health related quality of life (HRQOL)
EuroQoL-5D-5L
Measured: Baseline
Health related quality of life (HRQOL)
EuroQoL-5D-5L
Measured: 6-weeks
Health related quality of life (HRQOL)
EuroQoL-5D-5L
Measured: 6-months
Patient satisfaction with care
Patient Assessment of Integrated Elderly Care Questionnaire
Measured: 6-weeks
Patient satisfaction with care
Patient Assessment of Integrated Elderly Care Questionnaire
Measured: 6-months
Primary healthcare use (outside of community specialist team for older persons)
Process measure
Measured: 6-weeks
Primary healthcare use (outside of community specialist team for older persons)
Process measure
Measured: 6-months
Number of healthcare professional encounters by the community specialist team for older persons
Process measure
Measured: 6-weeks
Number of healthcare professional encounters by the community specialist team for older persons
Process measure
Measured: 6-months
Unplanned ED revisit
Process measure for hospital data base
Measured: 12-months
Unplanned hospitalisation
Process measure for hospital data base
Measured: 12-months
Nursing Home admission
Process measure
Measured: 12-months
Mortality
The number of participants who died following their index visit
Measured: 12-months
Health related quality of life (HRQOL)
EuroQoL-5D-5L
Measured: 12-months
Primary healthcare use (outside of community specialist team for older persons)
Process measure
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start15 Jan 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205238
- Sponsor's protocol ID
- HRB RL2020-010
- Status last verified
- Aug 2025
- First submitted
- 3 Jan 2024
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larkin E, O'Shaughnessy I, Galvin R, Robinson K. Recruitment of older adults to clinical trials in the Emergency Department: A qualitative study with clinical trial stakeholders. BMC Med Res Methodol. 2026 Feb 21;26(1):69. doi: 10.1186/s12874-025-02749-1.
PubMed 41723376
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Domiciliary Versus 'Hub' Based Comprehensive Geriatric Assessment on Clinical and Process Outcomes Among Older Adults Attending Community Specialist Teams: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06205238
- Acronym / sponsor ID
- HRB RL2020-010
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 12 Jan 2024 (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 investigators plan to implement a randomised controlled trial to examine the impact of domiciliary (home based) versus 'hub-based' Comprehensive Geriatric Assessment (CGA) on clinical and process outcomes among older adults referred to a community specialist team for older persons in the Mid-West region of Ireland. The population of interest is older adults who are discharged directly from the Emergency Department or referred urgently from their General Practitioner. The outcomes of interest focus on those that matter most to older adults as well as clinical and process measures of care.
Detailed description
CGA is defined as a "multidimensional interdisciplinary diagnostic process focused on determining a frail elderly person's medical, psychological and functional capability in order to develop a coordinated and integrated plan for treatment and long term follow up" (1). The CST hub in Limerick provides a rapid, single point of access to an outpatient specialist geriatrician and allied health professional assessment. The bulk of this therapy is delivered in each of the hubs. This is considered 'usual' or routine care for the purposes of this trial.
The intervention will consist of domiciliary multidisciplinary CGA and intervention including nursing, medical and allied health assessment and intervention for frail older adults over age 75 who are discharged from the ED, or referred urgently from their General Practitioner and referred to the CST in Limerick. The bulk of this intervention will be delivered in the patient's own home. Each participant will be required to attend the hub for their medical review where they will access specialist geriatric medical expertise. A domiciliary visit to the older person within 24-48 hours of referral from the ED or within 24-48 hours of triage of GP referral by a member of the multidisciplinary team will be carried out. This person will act as the case coordinator for the duration of the intervention. During this visit, there will be a detailed assessment of the older adult. The assessment will include but not be limited to a falls assessment, assessment of mobility and stairs, transfer, personal care, activities of daily living (ADLs), social supports, cognition, lying \& standing blood pressures and nutritional assessment. Referrals will be made for domiciliary care to the appropriate healthcare professionals (nursing, OT, physiotherapy, dietetics etc) based on the findings of this holistic assessment. Interventions prescribed will be individualised based on patient needs. The investigators will use the template proposed by Ellis et al. (2017) to characterise the components of the CGA intervention.
The trial will assess the benefits of this domiciliary model of care on outcomes including the following: function, quality of life, patient satisfaction, primary and secondary healthcare use, nursing home admission, mortality and cost-effectiveness. Baseline measurement will be taken at their index visit with follow-up at six weeks and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Domiciliary CGA | Experimental | Other: CGAThe intervention will consist of domiciliary CGA including nursing, medical and allied health assessment and intervention for frail older adults over age 75 who are discharged the ED or referred urgently from their GP and referred to the CST in Limerick. The bulk of this intervention will be delivered in the patient's own home. Each participant will be required to attend the hub for their medical review where they will access specialist geriatric medical expertise. A domiciliary visit to the older person within 24-48 hours of referral from the ED or within 24-48 hours of triage of GP referral by a member of the multidisciplinary team. This person will act as the case coordinator. During this visit, there will be a detailed assessment of the older adult. Referrals will be made for domiciliary care to the appropriate healthcare professionals based on patient. The template proposed by Ellis et al. (2017) will be used to characterise the components of the CGA intervention. |
| Hub-based CGA | Active comparator | Other: CGAThe intervention will consist of CGA as defined above, including nursing, medical and allied health assessment and intervention for frail older adults over age 75 who are discharged the ED or referred urgently from their General Practitioner and referred to the CST in Limerick and will be seen in the Out-patient CST setting. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Referred to the CST hub from a General Practitioner (urgent referral) or from the ED at University Hospital Limerick.
- All of criteria 1-5 must be met
- 75 years and over
- Evidence of frailty, scoring between 4 and 6 on the Rockwood Clinical Frailty Scale (pre-frail, mildly frail or moderately frail)
- Resides within CHO 3 and the catchment area of the relevant ICPOP hub
Key exclusion criteria (9 listed)
- Present with an acute neurological or cardiovascular event
- Are more appropriate to an alternative care pathway or service e.g. primary care or geriatric medicine clinic
- Present with injuries, unless the injury has already been appropriately managed,
- Are experiencing an acute medical illness requiring treatment in an acute hospital setting
- If care is being provided by other health care professionals at the time of referral and it is apparent that they are working to meet goals aligned with the current service
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 |
|---|---|---|
| CGACGA is defined as a "multidimensional interdisciplinary diagnostic process focused on determining a frail elderly person's medical, psychological and functional capability in order to develop a coordinated and integrated plan for treatment and long term follow up". | Other | Domiciliary CGA, Hub-based CGA |
Primary outcome
Functional status
Time frame: Baseline
Barthel Index
Functional status
Time frame: 6-weeks
Barthel Index
Functional status
Time frame: 6-months
Barthel Index
Functional status
Time frame: 12-months
Barthel Index
25 secondary outcomes
Unplanned ED revisit
Time frame: Baseline
Unplanned ED revisit
Time frame: 6-weeks
Unplanned ED revisit
Time frame: 6-months
Unplanned hospitalisation
Time frame: Baseline
Unplanned hospitalisation
Time frame: 6-weeks
Unplanned hospitalisation
Time frame: 6-months
Nursing Home admission
Time frame: 6-weeks
Nursing Home admission
Time frame: 6-months
Mortality
Time frame: 6-weeks
Mortality
Time frame: 6-months
Health related quality of life (HRQOL)
Time frame: Baseline
Health related quality of life (HRQOL)
Time frame: 6-weeks
Health related quality of life (HRQOL)
Time frame: 6-months
Patient satisfaction with care
Time frame: 6-weeks
Patient satisfaction with care
Time frame: 6-months
Primary healthcare use (outside of community specialist team for older persons)
Time frame: 6-weeks
Primary healthcare use (outside of community specialist team for older persons)
Time frame: 6-months
Number of healthcare professional encounters by the community specialist team for older persons
Time frame: 6-weeks
Number of healthcare professional encounters by the community specialist team for older persons
Time frame: 6-months
Unplanned ED revisit
Time frame: 12-months
Unplanned hospitalisation
Time frame: 12-months
Nursing Home admission
Time frame: 12-months
Mortality
Time frame: 12-months
Health related quality of life (HRQOL)
Time frame: 12-months
Primary healthcare use (outside of community specialist team for older persons)
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Derived from this study: PubMed 41723376Larkin E, O'Shaughnessy I, Galvin R, Robinson K. Recruitment of older adults to clinical trials in the Emergency Department: A qualitative study with clinical trial stakeholders. BMC Med Res Methodol. 2026 Feb 21;26(1):69. doi: 10.1186/s12874-025-02749-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGA in people with Frailty and Comprehensive Geriatric Assessment, run by University of Limerick at 1 site in Ireland.
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 12 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2025. 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Functional status (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT06205238, which also lists 1 linked publication.
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 20 Aug 2025.