DementiaINFOSA-DEMNCT04036955
Evaluation of an Innovative Information, Training and Social Support Intervention "INFOSADEM" to Principal Caregivers of Dementia Patients Living at Home
A study testing INFOSA-DEM in people with Dementia, run by Hospital Clinic of Barcelona.
Trial summary
Background: Dementia is an illness that mostly affects people of advanced age and causes disability and dependency. Although the difficulties, a vast number of older people with dementia at our context, are cared for in their own homes by a family member, usually their spouse/partner, son, daughter or companion, but… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- INFOSA-DEM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 31 Dec 2018
- 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
- People with a diagnose of dementia
- People older than 65 years old
- Living at home and receiving public formal care* from Primary Health Care centers.
- Having an informal caregiver** identified being capable of understand healthcare professional advices (this will be measured by healthcare professional criteria).
- Cognitive level having a MMSE score lower of 24 .
- We considered public formal care, the health care team working on Primary Care (being home care or primary care) (GPs, Registered Nurse, Social Worker). **We considered informal caregiver the person (family or not) who takes care of the PwD and lives together or visit him/her at least three times a week.
Who cannot join
- People lower than 65 years old
- People with a psychiatric symptom or Korsakov sindrome
- People without informal caregiver identified
About this study
Official title: Evaluation of an Innovative Information, Training and Social Support Intervention "INFOSADEM" to Principal Caregivers of Dementia Patients Living at Home. Experimental Study
Background: Dementia is an illness that mostly affects people of advanced age and causes disability and dependency. Although the difficulties, a vast number of older people with dementia at our context, are cared for in their own homes by a family member, usually their spouse/partner, son, daughter or companion, but it is well known that this could be one of the main factors of institutionalization. However, home care is an effective option for the health system. This care may be provided over months or years and can have negative effects on the caregivers' health. This article describes the development and implementation of a structured, psychoeducational intervention addressed to informal caregivers of people with dementia cared for at home.
Methods: A quasi-experimental study with repeated observations at 3 and 6 months post-intervention was performed. Intentional sampling and convenience assignment method was used for intervention and control groups. The intervention was structured developed at the beginning of the study, which consists of a multicomponent training, information and emotional support programme of five, 90-minute sessions over one week. The control group received Usual Care. The project was approved by the ethics committee (HCB/2014/0317) and follows the recommendations of the Declaration of Helsinki. Evidence gathered from our research will be published at national and international level.
Discussion: The results of this intervention will support other studies and contribute scientific evidence on the importance of promoting non-pharmacologic interventions in informal caregivers of people with dementia. At the same time, they can be used as the basis for the implementation of psycho educational interventions in home care and in long-term care institutions responsible for monitoring people with dementia; responding to training and information needs, and providing the social support that the caregivers themselves demand.
Read the detailed description
- Eligibility Criteria People with a diagnose of dementia, living at home and having an informal caregiver. Inclusion criteria
- People with a diagnose of dementia
- People older than 65 years old
- Living at home and receiving public formal care* from Primary Health Care centers.
- Having an informal caregiver** identified being capable of understand healthcare professional advices (this will be measured by healthcare professional criteria).
- Cognitive level having a MMSE score lower of 24 .
- Informed consent signed. *We considered public formal care, the health care team working on Primary Care (being home care or primary care) (GPs,Registered Nurse, Social Worker).
- We considered informal caregiver the person (family or not) who takes care of the PwD and lives together or visit him/her at least three times a week. Exclusion criteria
- People lower than 65 years old
- People with a psychiatric symptom or Korsakov sindrome
- People without informal caregiver identified
- Outcome measures
- preparation for care through the Preparedness for Caregiving Scale (PCS)
- Perceived Competence Scale for Care
- Inventory Family needs
- Zarit Burden Scale
- Katz Index of Independence in Activities of Daily Living
- positive and negative aspects of care with the Caregiver Reaction assessment (CRA)
- Perceived Social Support Questionnaire (Duke-UNK )
- Quality of Life Scale (EQ-5D)
- General Health Questionnaire (GHQ-12)
- Resource Utilization Questionnaire for dementia (RUD)
- Neuropsychiatric Inventory (NPI) .
- Quality of Life in Alzheimer's Disease (QoL-AD)
- Charlson Comorbidity Index (CCI)
- Mini-Mental State Examination (MMSE)
- Global Deterioration Scale (GDS)
- Conditions
- Dementia
- Being tested
- INFOSA-DEM
- Keywords
- dementia, Alzheimer's disease, patient care, home care
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFOSA-DEMOther
Caregivers in the intervention group received the INFOSA-DEM programme, together with usual care provided by the participating centres, while caregivers in the CG received usual care in the centres where the follow-up was carried out.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The INFOSA-DEM programme consists of five, 90-minute informational/training sessions delivered consecutively over one week. Morning or afternoon groups are offered depending on the caregiver's availability. Programme content was developed for use in small groups of 6-8 caregivers. Topics covered in the sessions include basic concepts in dementia and specific issues such as nutrition, rest, medication, physical and cognitive changes, management of behavioural symptoms, affective problems in the patient and informal caregiver, verbal and non-verbal communication techniques, caregiver self-care and information on available resources and community services.
The sessions are conducted using audio-visual material to facilitate understanding of the content and to encourage active participation among caregivers when talking about their experiences. Receives: Other: INFOSA-DEM |
| usual care | No intervention | Caregivers in the Group control received usual care in the centres where the follow-up was carried out. This consisted of annual or quarterly consultations with a health professional (GP, geriatrician or neurologist) and, depending on the health centre, a nurse and social worker.Currently, there is no homogenous protocol for all care centres for the patient with high levels of cognitive impairment and dependency. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preparedness for Caregiving
Preparedness for Caregiving Scale (PCS; 8 items): Assess readiness for tasks and demands of caregiving role. Domains include providing physical care, providing emotional support, setting up in-home support services and deling with the stress of caregiving. Participants are asked to identified how well prepared they feel on a scale from not all prepared (0) to very well prepared (4). Cronbach's Alpha: 0.88-93
Measured: 2 years
positive and negative aspects of care
. Caregiver Reaction Aspects (CRA; 24 items): consists of 24 items in five subscales: self-esteem (range 7-35), lack of family support (range 5-25), financial problems (range 3-15), disrupted schedule (range 5-25) and health problems (range 4-20).
Measured: 2 years
perceived social support
Perceived Social Support Questionnaire (Duke-UNK; 8 items): Instrument to measure the strength of the person's social support network. Cronbach's Alpha: 0.88.
Measured: 2 years
Level of Quality of life: EQ-5D
Quality of Life Scale (EQ-5D): a measure of self-reported quality of life that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Cronbach's Alpha: 0.87.
Measured: 2 years
FAMILY NEEDS
Family needs inventory
Measured: 2 years
level of burden
Zarit Burden Scale (ZBS; 22 items): a questionnaire developed to measure subjective burden among caregivers. Cronbach's Alpha: 0.92.
Measured: 2 years
Neuropsychiatric Inventory (NPI)
Assess dementia-related behavioral symptoms. Is composed by 10 sub-domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, deshinibition, irritability/liability, and aberrant motor activity. Cronbach's Alpha:0.88
Measured: 2 years
degree of independence in activities of daily living
Katz index of Activity of Daily Living (KATZ; 5 items): to assess an older adult's baseline ability to bathe, dress, use the toilet, transfer, remain continent, and feed her- or himself. It's also used for evaluating changes in response to illness. Cronbach's Alpha: 0.87
Measured: 2 years
Competence for care
The Perceived Competence Scale for Care
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Mar 2016
- Primary completion30 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Responsible party
- Principal investigator, Adelaida Zabalegui Yarnoz, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036955
- Sponsor's protocol ID
- HCB/2014/0317
- Acronym
- INFOSA-DEM
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Innovative Information, Training and Social Support Intervention "INFOSADEM" to Principal Caregivers of Dementia Patients Living at Home. Experimental Study
- ClinicalTrials.gov ID
- NCT04036955
- Acronym / sponsor ID
- INFOSA-DEM / HCB/2014/0317
- Conditions
- Dementia
- Keywords
- dementia, Alzheimer's disease, patient care, home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 Jul 2019 (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.
Background: Dementia is an illness that mostly affects people of advanced age and causes disability and dependency. Although the difficulties, a vast number of older people with dementia at our context, are cared for in their own homes by a family member, usually their spouse/partner, son, daughter or companion, but it is well known that this could be one of the main factors of institutionalization. However, home care is an effective option for the health system. This care may be provided over months or years and can have negative effects on the caregivers' health. This article describes the development and implementation of a structured, psychoeducational intervention addressed to informal caregivers of people with dementia cared for at home.
Methods: A quasi-experimental study with repeated observations at 3 and 6 months post-intervention was performed. Intentional sampling and convenience assignment method was used for intervention and control groups. The intervention was structured developed at the beginning of the study, which consists of a multicomponent training, information and emotional support programme of five, 90-minute sessions over one week. The control group received Usual Care. The project was approved by the ethics committee (HCB/2014/0317) and follows the recommendations of the Declaration of Helsinki. Evidence gathered from our research will be published at national and international level.
Discussion: The results of this intervention will support other studies and contribute scientific evidence on the importance of promoting non-pharmacologic interventions in informal caregivers of people with dementia. At the same time, they can be used as the basis for the implementation of psycho educational interventions in home care and in long-term care institutions responsible for monitoring people with dementia; responding to training and information needs, and providing the social support that the caregivers themselves demand.
Detailed description
- Eligibility Criteria People with a diagnose of dementia, living at home and having an informal caregiver. Inclusion criteria
- People with a diagnose of dementia
- People older than 65 years old
- Living at home and receiving public formal care* from Primary Health Care centers.
- Having an informal caregiver** identified being capable of understand healthcare professional advices (this will be measured by healthcare professional criteria).
- Cognitive level having a MMSE score lower of 24 .
- Informed consent signed. *We considered public formal care, the health care team working on Primary Care (being home care or primary care) (GPs,Registered Nurse, Social Worker).
- We considered informal caregiver the person (family or not) who takes care of the PwD and lives together or visit him/her at least three times a week. Exclusion criteria
- People lower than 65 years old
- People with a psychiatric symptom or Korsakov sindrome
- People without informal caregiver identified
- Outcome measures
- preparation for care through the Preparedness for Caregiving Scale (PCS)
- Perceived Competence Scale for Care
- Inventory Family needs
- Zarit Burden Scale
- Katz Index of Independence in Activities of Daily Living
- positive and negative aspects of care with the Caregiver Reaction assessment (CRA)
- Perceived Social Support Questionnaire (Duke-UNK )
- Quality of Life Scale (EQ-5D)
- General Health Questionnaire (GHQ-12)
- Resource Utilization Questionnaire for dementia (RUD)
- Neuropsychiatric Inventory (NPI) .
- Quality of Life in Alzheimer's Disease (QoL-AD)
- Charlson Comorbidity Index (CCI)
- Mini-Mental State Examination (MMSE)
- Global Deterioration Scale (GDS)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: INFOSA-DEMThe INFOSA-DEM programme consists of five, 90-minute informational/training sessions delivered consecutively over one week. Morning or afternoon groups are offered depending on the caregiver's availability. Programme content was developed for use in small groups of 6-8 caregivers. Topics covered in the sessions include basic concepts in dementia and specific issues such as nutrition, rest, medication, physical and cognitive changes, management of behavioural symptoms, affective problems in the patient and informal caregiver, verbal and non-verbal communication techniques, caregiver self-care and information on available resources and community services. The sessions are conducted using audio-visual material to facilitate understanding of the content and to encourage active participation among caregivers when talking about their experiences. |
| usual care | No intervention | –Caregivers in the Group control received usual care in the centres where the follow-up was carried out. This consisted of annual or quarterly consultations with a health professional (GP, geriatrician or neurologist) and, depending on the health centre, a nurse and social worker.Currently, there is no homogenous protocol for all care centres for the patient with high levels of cognitive impairment and dependency. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- People with a diagnose of dementia
- People older than 65 years old
- Living at home and receiving public formal care* from Primary Health Care centers.
- Having an informal caregiver** identified being capable of understand healthcare professional advices (this will be measured by healthcare professional criteria).
- Cognitive level having a MMSE score lower of 24 .
Key exclusion criteria (3 listed)
- People lower than 65 years old
- People with a psychiatric symptom or Korsakov sindrome
- People without informal caregiver identified
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 |
|---|---|---|
| INFOSA-DEMCaregivers in the intervention group received the INFOSA-DEM programme, together with usual care provided by the participating centres, while caregivers in the CG received usual care in the centres where the follow-up was carried out. | Other | intervention group |
Primary outcome
Preparedness for Caregiving
Time frame: 2 years
Preparedness for Caregiving Scale (PCS; 8 items): Assess readiness for tasks and demands of caregiving role. Domains include providing physical care, providing emotional support, setting up in-home support services and deling with the stress of caregiving. Participants are asked to identified how well prepared they feel on a scale from not all prepared (0) to very well prepared (4). Cronbach's Alpha: 0.88-93
positive and negative aspects of care
Time frame: 2 years
. Caregiver Reaction Aspects (CRA; 24 items): consists of 24 items in five subscales: self-esteem (range 7-35), lack of family support (range 5-25), financial problems (range 3-15), disrupted schedule (range 5-25) and health problems (range 4-20).
perceived social support
Time frame: 2 years
Perceived Social Support Questionnaire (Duke-UNK; 8 items): Instrument to measure the strength of the person's social support network. Cronbach's Alpha: 0.88.
Level of Quality of life: EQ-5D
Time frame: 2 years
Quality of Life Scale (EQ-5D): a measure of self-reported quality of life that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Cronbach's Alpha: 0.87.
FAMILY NEEDS
Time frame: 2 years
Family needs inventory
level of burden
Time frame: 2 years
Zarit Burden Scale (ZBS; 22 items): a questionnaire developed to measure subjective burden among caregivers. Cronbach's Alpha: 0.92.
Neuropsychiatric Inventory (NPI)
Time frame: 2 years
Assess dementia-related behavioral symptoms. Is composed by 10 sub-domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, deshinibition, irritability/liability, and aberrant motor activity. Cronbach's Alpha:0.88
degree of independence in activities of daily living
Time frame: 2 years
Katz index of Activity of Daily Living (KATZ; 5 items): to assess an older adult's baseline ability to bathe, dress, use the toilet, transfer, remain continent, and feed her- or himself. It's also used for evaluating changes in response to illness. Cronbach's Alpha: 0.87
Competence for care
Time frame: 2 years
The Perceived Competence Scale for Care
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 30 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing INFOSA-DEM in people with Dementia, run by Hospital Clinic of Barcelona.
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 3 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 30 Jul 2019. 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?
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?
Preparedness for Caregiving (time frame: 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2019.