Dependency BurdenICIASNCT02065427
Intervention to Improve Social and Family Support for Caregivers of Dependent Patients. (ICIAS)
A study testing Social Support in people with Dependency Burden, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The purpose of this study is to determine wether a multi-factor intervention involving the primary caregiver of a dependent patient, with the goal of improving his or her social and family support and carried out by the professionals of the patient's regular PHCT, will decrease the burden and increase quality of life… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dependency Burden
- What is being tested?
- Social Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteSpain
- Study dates
- May 2010to Dec 2012
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (older than 18 years) identified in the eCAP database as the primary caregiver for a dependent patient, and who act as caregivers without remuneration.
- Both the caregivers and the dependent patients have an active clinical record in a participating primary care centre.
- -
Who cannot join
- 1. Caregivers for intermittent periods, independently of the length of care provided.
- 2. Caregivers who have provided less than one year of ongoing care. 3. Caregivers with any communication problem (psychiatric disorders, etc.) that makes them difficult to interview
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention to Improve Social and Family Support for Caregivers of Dependent Patients
The purpose of this study is to determine wether a multi-factor intervention involving the primary caregiver of a dependent patient, with the goal of improving his or her social and family support and carried out by the professionals of the patient's regular PHCT, will decrease the burden and increase quality of life for the primary caregiver.
Read the detailed description
Objective: To assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life.
Methodology:
Design: Controlled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT).
Study area: Primary Health Care network (9 PHCTs). Study participants: Primary informal caregivers of patients receiving home health care from participating PHCTs.
Sample: Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group.
Intervention: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support.
Control: Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request.
Data Analysis. Dependent variables: Caregiver burden (short-form Zarit test), caregivers social support (Medical Outcomes Study), and caregiver reported quality of life (SF-12) Independent variables: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test)
Discussion:
If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice.
- Conditions
- Dependency Burden
- Being tested
- Social Support
- Keywords
- Caregiver, Burden, Social support, Primary health Care, Home Care, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social SupportBehavioural
- PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support.
| Study group | Role | What they receive |
|---|---|---|
| Social support | Experimental | Social support intervention
Intervention is performed by the health professionals working at the primary health care team responsible for the patient, and consisits of the following components:
a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Receives: Behavioral: Social Support |
| Usual home health care | No intervention | Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score in Zarit's short version test for caregiver's burden
Difference in Zarit's score in the primary caregiver for a dependent patient before and after iintervention
Measured: 6 months
Secondary outcomes (1)
Score in caregivers social support (Medical Outcomes Study), (MOS)
Difference in score in MOS Test beefore and after intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startMay 2010
- Primary completionJan 2011
- Study completionDec 2012
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 Dependency BurdenStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Responsible party
- Sponsor
- Investigators
- Magdalena I Rosell-Murphy, MD, Study director, Institut Català de la SalutJosep Mª Bonet, MD, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065427
- Sponsor's protocol ID
- ICIAS
- Acronym
- ICIAS
- Status last verified
- Feb 2014
- First submitted
- 16 Feb 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosell-Murphy M, Bonet-Simo JM, Baena E, Prieto G, Bellerino E, Sole F, Rubio M, Krier I, Torres P, Mimoso S; ICIAS research group. Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol. BMC Fam Pract. 2014 Mar 25;15:53. doi: 10.1186/1471-2296-15-53.
PubMed 24666438
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Improve Social and Family Support for Caregivers of Dependent Patients
- ClinicalTrials.gov ID
- NCT02065427
- Acronym / sponsor ID
- ICIAS / ICIAS
- Conditions
- Dependency Burden
- Keywords
- Caregiver, Burden, Social support, Primary health Care, Home Care, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Catala de Salut, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Study start
- May 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Feb 2014 (estimated)
- 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 purpose of this study is to determine wether a multi-factor intervention involving the primary caregiver of a dependent patient, with the goal of improving his or her social and family support and carried out by the professionals of the patient's regular PHCT, will decrease the burden and increase quality of life for the primary caregiver.
Detailed description
Objective: To assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life.
Methodology:
Design: Controlled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT).
Study area: Primary Health Care network (9 PHCTs). Study participants: Primary informal caregivers of patients receiving home health care from participating PHCTs.
Sample: Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group.
Intervention: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support.
Control: Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request.
Data Analysis. Dependent variables: Caregiver burden (short-form Zarit test), caregivers social support (Medical Outcomes Study), and caregiver reported quality of life (SF-12) Independent variables: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test)
Discussion:
If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social support | Experimental | Behavioral: Social SupportSocial support intervention Intervention is performed by the health professionals working at the primary health care team responsible for the patient, and consisits of the following components: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. |
| Usual home health care | No intervention | –Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (older than 18 years) identified in the eCAP database as the primary caregiver for a dependent patient, and who act as caregivers without remuneration.
- Both the caregivers and the dependent patients have an active clinical record in a participating primary care centre.
- -
Key exclusion criteria (2 listed)
- 1. Caregivers for intermittent periods, independently of the length of care provided.
- 2. Caregivers who have provided less than one year of ongoing care. 3. Caregivers with any communication problem (psychiatric disorders, etc.) that makes them difficult to interview
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 |
|---|---|---|
| Social Supporta) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. | Behavioural | Social support |
Primary outcome
Score in Zarit's short version test for caregiver's burden
Time frame: 6 months
Difference in Zarit's score in the primary caregiver for a dependent patient before and after iintervention
1 secondary outcome
Score in caregivers social support (Medical Outcomes Study), (MOS)
Time frame: 6 months
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 19 Feb 2014.
- Derived from this study: PubMed 24666438Rosell-Murphy M, Bonet-Simo JM, Baena E, Prieto G, Bellerino E, Sole F, Rubio M, Krier I, Torres P, Mimoso S; ICIAS research group. Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol. BMC Fam Pract. 2014 Mar 25;15:53. doi: 10.1186/1471-2296-15-53.
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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.
Magdalena I Rosell-Murphy, MD study director
Institut Català de la Salut
Josep Mª Bonet, MD principal investigator
Institut Català de la Salut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Support in people with Dependency Burden, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 19 Feb 2014. 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 Spain. 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?
Score in Zarit's short version test for caregiver's burden (time frame: 6 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 NCT02065427, 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 19 Feb 2014.