GeriatricsVMCatNCT05567965
Live Better at Home in Catalonia
A study testing Home care intervention in people with Geriatrics and Home Care Services, run by University of Vic - Central University of Catalonia.
Trial summary
The intensity of the home care interventions for dependent older people offered in Spain, and specifically in Catalonia, may not be sufficient to help keep older people at home and delay institutionalisation in a nursing home, but an intensification of the intervention could improve the health and psychosocial state… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatrics, Home Care Services
- What is being tested?
- Home care intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Jun 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older people (men and women aged 65 and over).
- Living in the community.
- Categorized with a degree II or III of dependency.
- Users of the public home care without requesting admission to an institution in Catalonia.
- With a main informal caregiver in charge.
- The acceptance to participate in the study of the user and the informal caregiver.
Who cannot join
- Users with privately paid professional carers.
- Users in palliative care (short life expectancy).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Live Better at Home (Catalonia): a Randomized Clinical Trial
The intensity of the home care interventions for dependent older people offered in Spain, and specifically in Catalonia, may not be sufficient to help keep older people at home and delay institutionalisation in a nursing home, but an intensification of the intervention could improve the health and psychosocial state of dependent people and their informal caregivers and facilitate their permanence at home.
Read the detailed description
According to recent surveys, more than 80% of older people prefer to live at home, so the current model of care should aim to prolong the autonomy of older people so that they remain as long as possible at home and delay their entry into nursing homes.
The hypothesis of the study is that an intensification of the home care intervention in users with degree II or III of dependency will delay or avoid their institutionalisation in nursing homes.
The main aim of the study is to evaluate the effect of an intensification in home care interventions on users with grade II or III dependency in order to delay or avoid their institutionalisation in a geriatric residence.
Secondary aims are to analyse the effect of an intensification of home care interventions in users with degree II or III of dependency on their health and psychosocial state.To analyse the effect of an intensification of home care intervention together with training for informal caregivers on the health status and overburden of informal caregivers of users with degree II or III of dependency.
To test the impact on the use of resources of an intensification of home care interventions in users with degree II or III of dependency.
A randomised clinical trial with two parallel arms and blinded assessment will be conducted. The duration of follow-up will be 18 months. It will be carried out at the community level in homes in eight municipalities in the province of Barcelona, Catalonia (Spain).
- Conditions
- Geriatrics, Home Care Services
- Being tested
- Home care intervention
- Keywords
- Older people, Home care, Functional capacity, Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home care interventionOther
The duration of the intervention, both for the control group and the intervention group, will be 18 months or until the user's admission to the nursing home.
| Study group | Role | What they receive |
|---|---|---|
| Intensified home care intervention + Training | Experimental | Users will receive an intensification in their home care intervention for dependence, receiving an intervention of a minimum of 1 hour per day and a maximum of 3.5 hours, to support their activities of daily living. The intensification will be personalised according to the specific needs of the user that the professionals consider necessary to attend. The weekly distribution of the intervention will be flexible in terms of timetables, as agreed between professional and informal caregivers. In addition, each informal caregiver will receive multimodal online training with the aim of providing knowledge, skills and attitudes that empower them to face the challenge of caring, guaranteeing quality care, preventing situations that may negatively affect both the person and the family dynamics and enabling an optimal evolution in caregiving. Receives: Other: Home care intervention |
| Conventional home care intervention | Active comparator | Participants will continue with their conventional home care intervention for dependence, comprising activities that are mainly carried out at the users' home and are oriented towards supporting their activities of daily living. This intervention is of personalised attention and its average intensity is about 20 minutes per day. Receives: Other: Home care intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time from baseline until application for nursing home admission
To the user. Assessed by asking.
Measured: Every month up to 18 months. Assessed from the baseline in the study until the application for entry in nursing home, assessed up to 18 months.
Secondary outcomes (8)
Functional capacity
To the user. Assessed by the Barthel Index. The scoring range is 0 (total dependency)-100 (slight dependency)
Measured: Every 3 months up to 18 months.
Frailty
To the user. Assessed by the Frail-VIG index. The scoring range is 0 (no frailty)- 25 (advanced frailty).
Measured: Every 3 months up to 18 months.
Risk of sarcopenia
To the user. Assessed by the strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire. The scoring range is 0 - 10 (more than 4 points means risk of sarcopenia).
Measured: Every 3 months up to 18 months.
Risk of falls
To the user. Assessed by the Downton Scale. The scoring range is 0 - 14 (more than 3 points means risk of falls).
Measured: Every 3 months up to 18 months.
Cognitive status
To the user. Assessed by the Reisberg Global Deterioration Scale. The scoring range is 1 (no dementia)- 7 (late-stage dementia).
Measured: Every 3 months up to 18 months.
Social network
To the user. Assessed by the Lubben Social Network Scale. The scoring range is 0 (less social engagement)- 30 (more social engagement).
Measured: Every 3 months up to 18 months.
Chronic patient experience
To the user. Assessed by the Chronic Patient Experince Evaluation Instrument (IEXPAC). The scoring range is 0 (worst experience)- 110 (best experience).
Measured: Every 3 months up to 18 months.
Quality of life related with health
To the user. Assessed by the EUROQOL-5D-3L. The scoring range is 0 (worst quality of life)- 100 (best quality of life).
Measured: Every 1 month up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (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 GeriatricsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Geriatrics and Gerontology
- Responsible party
- Principal investigator, Eduard Minobes, University of Vic - Central University of Catalonia
- Investigators
- Jose Augusto Garcia Navarro, Principal investigator, Spanish Society of Geriatrics and Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567965
- Sponsor's protocol ID
- VMCCat1.0
- Acronym
- VMCat
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data will result in some publications
Publications
Minobes-Molina E, Pamies-Tejedor S, Roncal-Belzunce V, Escalada San Adrian G, Atares Rodriguez L, Garcia-Navarro JA. Multimodal home care intervention for dependent older people "Live better at home": Protocol of a randomized clinical trial. Rev Esp Geriatr Gerontol. 2023 Jul-Aug;58(4):101383. doi: 10.1016/j.regg.2023.101383. Epub 2023 Jul 13.
PubMed 37453249
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Better at Home (Catalonia): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05567965
- Acronym / sponsor ID
- VMCat / VMCCat1.0
- Conditions
- Geriatrics, Home Care Services
- Keywords
- Older people, Home care, Functional capacity, Dependence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Spanish Society of Geriatrics and Gerontology
- Study start
- Nov 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 5 Oct 2022 (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 intensity of the home care interventions for dependent older people offered in Spain, and specifically in Catalonia, may not be sufficient to help keep older people at home and delay institutionalisation in a nursing home, but an intensification of the intervention could improve the health and psychosocial state of dependent people and their informal caregivers and facilitate their permanence at home.
Detailed description
According to recent surveys, more than 80% of older people prefer to live at home, so the current model of care should aim to prolong the autonomy of older people so that they remain as long as possible at home and delay their entry into nursing homes.
The hypothesis of the study is that an intensification of the home care intervention in users with degree II or III of dependency will delay or avoid their institutionalisation in nursing homes.
The main aim of the study is to evaluate the effect of an intensification in home care interventions on users with grade II or III dependency in order to delay or avoid their institutionalisation in a geriatric residence.
Secondary aims are to analyse the effect of an intensification of home care interventions in users with degree II or III of dependency on their health and psychosocial state.To analyse the effect of an intensification of home care intervention together with training for informal caregivers on the health status and overburden of informal caregivers of users with degree II or III of dependency.
To test the impact on the use of resources of an intensification of home care interventions in users with degree II or III of dependency.
A randomised clinical trial with two parallel arms and blinded assessment will be conducted. The duration of follow-up will be 18 months. It will be carried out at the community level in homes in eight municipalities in the province of Barcelona, Catalonia (Spain).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified home care intervention + Training | Experimental | Other: Home care interventionUsers will receive an intensification in their home care intervention for dependence, receiving an intervention of a minimum of 1 hour per day and a maximum of 3.5 hours, to support their activities of daily living. The intensification will be personalised according to the specific needs of the user that the professionals consider necessary to attend. The weekly distribution of the intervention will be flexible in terms of timetables, as agreed between professional and informal caregivers. In addition, each informal caregiver will receive multimodal online training with the aim of providing knowledge, skills and attitudes that empower them to face the challenge of caring, guaranteeing quality care, preventing situations that may negatively affect both the person and the family dynamics and enabling an optimal evolution in caregiving. |
| Conventional home care intervention | Active comparator | Other: Home care interventionParticipants will continue with their conventional home care intervention for dependence, comprising activities that are mainly carried out at the users' home and are oriented towards supporting their activities of daily living. This intervention is of personalised attention and its average intensity is about 20 minutes per day. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Older people (men and women aged 65 and over).
- Living in the community.
- Categorized with a degree II or III of dependency.
- Users of the public home care without requesting admission to an institution in Catalonia.
- With a main informal caregiver in charge.
Key exclusion criteria (2 listed)
- Users with privately paid professional carers.
- Users in palliative care (short life expectancy).
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 |
|---|---|---|
| Home care interventionThe duration of the intervention, both for the control group and the intervention group, will be 18 months or until the user's admission to the nursing home. | Other | Conventional home care intervention, Intensified home care intervention + Training |
Primary outcome
Change in time from baseline until application for nursing home admission
Time frame: Every month up to 18 months. Assessed from the baseline in the study until the application for entry in nursing home, assessed up to 18 months.
To the user. Assessed by asking.
8 secondary outcomes
Functional capacity
Time frame: Every 3 months up to 18 months.
Frailty
Time frame: Every 3 months up to 18 months.
Risk of sarcopenia
Time frame: Every 3 months up to 18 months.
Risk of falls
Time frame: Every 3 months up to 18 months.
Cognitive status
Time frame: Every 3 months up to 18 months.
Social network
Time frame: Every 3 months up to 18 months.
Chronic patient experience
Time frame: Every 3 months up to 18 months.
Quality of life related with health
Time frame: Every 1 month up to 18 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Derived from this study: PubMed 37453249Minobes-Molina E, Pamies-Tejedor S, Roncal-Belzunce V, Escalada San Adrian G, Atares Rodriguez L, Garcia-Navarro JA. Multimodal home care intervention for dependent older people "Live better at home": Protocol of a randomized clinical trial. Rev Esp Geriatr Gerontol. 2023 Jul-Aug;58(4):101383. doi: 10.1016/j.regg.2023.101383. Epub 2023 Jul 13.
- Individual participant dataSharing planned: Yes. All collected data will result in some publications
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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.
Jose Augusto Garcia Navarro principal investigator
Spanish Society of Geriatrics and Gerontology
Questions about this trial
What is this clinical trial studying?
A study testing Home care intervention in people with Geriatrics and Home Care Services, run by University of Vic - Central University of Catalonia.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduard Minobes (+34659350407, eduard.minobes@segg.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time from baseline until application for nursing home admission (time frame: Every month up to 18 months. Assessed from the baseline in the study until the application for entry in nursing home, assessed up to 18 months.). 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 NCT05567965, 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 5 Oct 2022.