Caregiver Subjective BurdeniSupportPTNCT04104568
Effectiveness of an Online Training and Support Program (iSupport) for Informal Dementia Caregivers
A study testing iSupport for dementia - European-Portuguese version and e-book (comparator) in people with Caregiver Subjective Burden and Depressive Symptoms, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Informal caregivers of people with dementia are at greater risk of developing physical and mental health problems when compared to the general population and to informal caregivers of people with other chronic diseases. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Caregiver Subjective Burden, Depressive Symptoms, Anxiety Symptoms
- What is being tested?
- iSupport for dementia - European-Portuguese version and e-book (comparator)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Mar 2020to Dec 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Portuguese adults (≥18 years) (as self-reported and reported by professionals in the referral process);
- Giving consent to participate (Electronic Informed Consent);
- Providing non-paid care for at least 6 months at the time of the recruitment (as self-reported and reported by professionals in the referral process);
- Caring for a person holding a formal diagnosis of dementia (as reported by professionals in the referral process);
- Be skilled to use the internet (as self-reported and reported by professionals in the referral process);
- Experiencing either a clinically relevant level of subjective burden, as determined by a total score ≥ 21 on the Zarit Burden Interview or depression or anxiety symptoms, determined by a score ≥ 8 in at least one of the subscales of the Hospital Anxiety and Depression Scale.
Who cannot join
- Unable to comprehend written Portuguese (as reported by professionals in the referral process);
- Not having access to a device with internet connection at least twice a week (as self-reported and reported by professionals in the referral process);
- Declaring to care for a person in institutional care (e.g. nursing home or continued care unit) (as self-reported and reported by professionals in the referral process).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Online Training and Support Program (iSupport Portuguese Version) to Reduce Burden, Depression and Anxiety and to Improve Quality of Life, Positive Aspects of Caregiving and Self-efficacy in Informal Dementia Caregivers
Informal caregivers of people with dementia are at greater risk of developing physical and mental health problems when compared to the general population and to informal caregivers of people with other chronic diseases. Internet-based interventions have been explored in its potential to minimize the negative effects of caring, accounting for their ubiquitous nature, convenient delivery, potential scalability and presumed (cost)effectiveness. iSupport is a self-help online program developed by the World Health Organization to provide education, skills training and support to informal caregivers of people with dementia. This intervention study aims to determine the effectiveness of a Portuguese culturally adapted version of iSupport to decrease caregiver burden, symptoms of depression and anxiety, and to improve quality of life, positive aspects of caregiving and general self-efficacy. The study has two arms: access to "iSupport" for three months or access to an education-only e-book. iSupport is grounded in problem-solving and cognitive behavioral therapy techniques and it consists of 23 lessons organized around 5 modules: 'Introduction to dementia'; 'Being a carer', 'Caring for me', 'Providing everyday care', and 'Dealing with behaviour changes'.
One hundred and eighty four participants will be recruited by referral from national Alzheimer's associations. Participants will be included if they match the following criteria: being 18 years or older and provide e-consent; being a self-reported non-paid caregiver for at least 6 months; caring for a person with a formal diagnosis of Alzheimer's disease; being skilled to use internet; and experience a clinically relevant level of burden or depression or anxiety symptoms. Data is collected online, resorting to self-administered instruments, at baseline, 3 and 6 months after baseline. A two-sided alternative hypothesis was assumed for this study: Mean caregiver burden at 3 months after baseline is different in informal caregivers of people with dementia assigned to the iSupport program as in those assigned to a minimal education-only intervention. Findings from this intervention study will offer evidence to support an informed decision making on scaling up iSupport as a new intervention program with minimal costs aimed at minimizing the psychological distress of informal caregivers of people with dementia in Portugal and elsewhere.
- Being tested
- iSupport for dementia - European-Portuguese version, e-book (comparator)
- Keywords
- Informal caregivers, People with Dementia, Mental Health, Online training and support, Intervention Study
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSupport for dementia - European-Portuguese versionBehavioural
iSupport for dementia, European-Portuguese version consists in an online self-help training and support program developed by the World Health Organization to to provide education, skills training and support to informal caregivers of people with dementia and culturally adapted to Portugal by the Institute of Biomedical Sciences Abel Salazar and CINTESIS. Framed as a multi-component intervention, iSupport is grounded in problem-solving and cognitive behavioral therapy techniques. The program comprises 23 lessons on dementia and caregiver support distributed by 5 modules: 'Introduction to dementia'; 'Being a carer'; 'Caring for me'; 'Providing everyday care' and 'Dealing with behavior changes'. The education plan can be personalized by the caregiver and each lesson includes interactive exercises with immediate feedback; and positive messages as well as 'skills certificates' are displayed when lessons are completed.
e-book (comparator)Other
The e-book contains information on relevant topics for dementia and caregiving, including basic information about dementia; practical tips on managing dementia; the changing needs of a person with dementia; dealing with care provision; caring for oneself (the caregiver) and finding emotional support; dealing with the death of the care receiver; relevant legislation (e.g. advance directives); how to get help; and how to reach the national Alzheimer's Association.
| Study group | Role | What they receive |
|---|---|---|
| iSupport for dementia - European-Portuguese version | Experimental | Access, for 3 months, to an online self-help training and support program: iSupport for dementia - European-Portuguese version. The e-program offers information, skills training and support for informal caregivers of people with dementia. It comprises five modules, including twenty-three lessons on dementia and caregiver support. In line with good practices on digital engagement, the education plan can be personalized by the caregiver. This means that it can be adjusted to the person's availability and lessons can be selected according to particular needs. Each lesson includes interactive exercises with immediate feedback; and positive messages as well as 'skills certificates' are displayed when lessons are completed. Framed as a multi-component intervention, iSupport is grounded in problem-solving and cognitive behavioral therapy techniques including psycho-education, behavioral activation, cognitive reframing, relaxation and antecedent-behavior-consequence (ABC) analysis. Receives: Behavioral: iSupport for dementia - European-Portuguese version |
| Education-only e-book | Active comparator | The control group will receive a minimal education-only intervention, consisting on an e-book. The manual contains information on relevant topics for dementia and caregiving, including basic information about dementia; practical tips on managing dementia; the changing needs of a person with dementia; dealing with care provision; caring for oneself (the caregiver) and finding emotional support; dealing with the death of the care receiver; relevant legislation (e.g. advance directives); how to get help; and how to reach the national Alzheimer's Association. Receives: Other: e-book (comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in subjective burden using the Zarit Burden Interview (ZBI)
Caregiver burden measured with the Zarit Burden Interview (ZBI), Portuguese validated version, total score. The instrument comprises 22 items answered on a 5-point scale, ranging from 0 (never) to 4 (almost always) except for the final question on global burden, rated from 0 (not at all) to 4 (extremely). Total score for the ZBI ranges from 0 to 88 points, with higher scores indicating greater burden. The ZBI has good internal consistency (0.89), test-retest and interrater reliability as well as construct and concurrent validity, including reports of positive correlation with depression symptoms and time devoted to care provision. Regarding the psychometric properties of ZBI in Portugal, face, content, ecological, discriminant and convergent validity were documented, along with test-retest reliability (ICC= 0.93, CI95% 0.88 - 0.96, p < 0.001) and internal consistency (α = 0.88). The ZBI is one of the most used instruments to measure burden in intervention studies with caregivers.
Measured: Baseline, Month 3, Month 6
Secondary outcomes (4)
Change from baseline in symptoms of depression and anxiety using the Hospital Anxiety and Depression Scale (HADS)
Symptoms of depression and anxiety measured through the Portuguese version of the Hospital Anxiety and Depression Scale (HADS), total scores. The instrument comprises two subscales with 7 items each, using a 4-point scale. Total scores for each scale range from 0 to 21, with higher scores indicating more severe anxiety or depression symptoms.
Measured: Baseline, Month 3, Month 6
Change from baseline in quality of life using the WHOQOL-BREF
Quality of life measured by the Portuguese version of the WHOQOL-BREF Physical, Psychological, Social relationships and Environment, total transformed scores. The instrument contains 26 items, for total transformed scores ranging between 0 to 100 points, with higher scores denoting higher quality of life.
Measured: Baseline, Month 3, Month 6
Change from baseline in Positive Aspects of Caregiving using the Positive Aspects of Caregiving (PAC)
Positive role appraisals mediating between the stressor and caregiver well-being, measured through the Portuguese version of Positive Aspects of Caregiving (PAC), total score. This instrument comprises 11 items answered in a 5-point scale, for a total score ranging between 11 to 55 points and higher scores representing more positive appraisals.
Measured: Baseline, Month 3, Month 6
Change from baseline in General self-efficacy using the Generalized self-efficacy scale
General self-efficacy, measured through the total score of the Generalized self-efficacy scale. The scale comprises 10 items answered in a 4-point scale for a total score ranging between 10 to 40 points, and higher scores representing a higher general self-efficacy.
Measured: Baseline, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start5 Mar 2020
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: There were issues with the technical service provider of the platform iSupport-Portugal; the platform and its backoffice should be implemented by another service provider. A pilot study was conducted following the protocol of the full trial.
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 Caregiver Subjective 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
- Model description
- Experimental parallel between-group design with two arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soraia T Sousa, M.S., Principal investigator, Instituto de Ciências Biomédicas Abel Salazar - Universidade do Porto; CINTESISConstança Paúl, PhD, Study director, Instituto de Ciências Biomédicas Abel Salazar - Universidade do Porto; CINTESIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104568
- Sponsor's protocol ID
- iSupport Portugal 208/18
- Acronym
- iSupportPT
- Status last verified
- Nov 2022
- First submitted
- 19 Sep 2019
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teles S, Ferreira A, Paul C. Feasibility of an online training and support program for dementia carers: results from a mixed-methods pilot randomized controlled trial. BMC Geriatr. 2022 Mar 1;22(1):173. doi: 10.1186/s12877-022-02831-z.
PubMed 35232389Teles S, Ferreira A, Seeher K, Freel S, Paul C. Online training and support program (iSupport) for informal dementia caregivers: protocol for an intervention study in Portugal. BMC Geriatr. 2020 Jan 8;20(1):10. doi: 10.1186/s12877-019-1364-z.
PubMed 31914936
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Online Training and Support Program (iSupport Portuguese Version) to Reduce Burden, Depression and Anxiety and to Improve Quality of Life, Positive Aspects of Caregiving and Self-efficacy in Informal Dementia Caregivers
- ClinicalTrials.gov ID
- NCT04104568
- Acronym / sponsor ID
- iSupportPT / iSupport Portugal 208/18
- Keywords
- Informal caregivers, People with Dementia, Mental Health, Online training and support, Intervention Study
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: There were issues with the technical service provider of the platform iSupport-Portugal; the platform and its backoffice should be implemented by another service provider. A pilot study was conducted following the protocol of the full trial.
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Sep 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.
Informal caregivers of people with dementia are at greater risk of developing physical and mental health problems when compared to the general population and to informal caregivers of people with other chronic diseases. Internet-based interventions have been explored in its potential to minimize the negative effects of caring, accounting for their ubiquitous nature, convenient delivery, potential scalability and presumed (cost)effectiveness. iSupport is a self-help online program developed by the World Health Organization to provide education, skills training and support to informal caregivers of people with dementia. This intervention study aims to determine the effectiveness of a Portuguese culturally adapted version of iSupport to decrease caregiver burden, symptoms of depression and anxiety, and to improve quality of life, positive aspects of caregiving and general self-efficacy. The study has two arms: access to "iSupport" for three months or access to an education-only e-book. iSupport is grounded in problem-solving and cognitive behavioral therapy techniques and it consists of 23 lessons organized around 5 modules: 'Introduction to dementia'; 'Being a carer', 'Caring for me', 'Providing everyday care', and 'Dealing with behaviour changes'.
One hundred and eighty four participants will be recruited by referral from national Alzheimer's associations. Participants will be included if they match the following criteria: being 18 years or older and provide e-consent; being a self-reported non-paid caregiver for at least 6 months; caring for a person with a formal diagnosis of Alzheimer's disease; being skilled to use internet; and experience a clinically relevant level of burden or depression or anxiety symptoms. Data is collected online, resorting to self-administered instruments, at baseline, 3 and 6 months after baseline. A two-sided alternative hypothesis was assumed for this study: Mean caregiver burden at 3 months after baseline is different in informal caregivers of people with dementia assigned to the iSupport program as in those assigned to a minimal education-only intervention. Findings from this intervention study will offer evidence to support an informed decision making on scaling up iSupport as a new intervention program with minimal costs aimed at minimizing the psychological distress of informal caregivers of people with dementia in Portugal and elsewhere.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental parallel between-group design with two arms.
| Arm | Type | Receives |
|---|---|---|
| iSupport for dementia - European-Portuguese version | Experimental | Behavioral: iSupport for dementia - European-Portuguese versionAccess, for 3 months, to an online self-help training and support program: iSupport for dementia - European-Portuguese version. The e-program offers information, skills training and support for informal caregivers of people with dementia. It comprises five modules, including twenty-three lessons on dementia and caregiver support. In line with good practices on digital engagement, the education plan can be personalized by the caregiver. This means that it can be adjusted to the person's availability and lessons can be selected according to particular needs. Each lesson includes interactive exercises with immediate feedback; and positive messages as well as 'skills certificates' are displayed when lessons are completed. Framed as a multi-component intervention, iSupport is grounded in problem-solving and cognitive behavioral therapy techniques including psycho-education, behavioral activation, cognitive reframing, relaxation and antecedent-behavior-consequence (ABC) analysis. |
| Education-only e-book | Active comparator | Other: e-book (comparator)The control group will receive a minimal education-only intervention, consisting on an e-book. The manual contains information on relevant topics for dementia and caregiving, including basic information about dementia; practical tips on managing dementia; the changing needs of a person with dementia; dealing with care provision; caring for oneself (the caregiver) and finding emotional support; dealing with the death of the care receiver; relevant legislation (e.g. advance directives); how to get help; and how to reach the national Alzheimer's Association. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Portuguese adults (≥18 years) (as self-reported and reported by professionals in the referral process);
- Giving consent to participate (Electronic Informed Consent);
- Providing non-paid care for at least 6 months at the time of the recruitment (as self-reported and reported by professionals in the referral process);
- Caring for a person holding a formal diagnosis of dementia (as reported by professionals in the referral process);
- Be skilled to use the internet (as self-reported and reported by professionals in the referral process);
Key exclusion criteria (3 listed)
- Unable to comprehend written Portuguese (as reported by professionals in the referral process);
- Not having access to a device with internet connection at least twice a week (as self-reported and reported by professionals in the referral process);
- Declaring to care for a person in institutional care (e.g. nursing home or continued care unit) (as self-reported and reported by professionals in the referral process).
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 |
|---|---|---|
| iSupport for dementia - European-Portuguese versioniSupport for dementia, European-Portuguese version consists in an online self-help training and support program developed by the World Health Organization to to provide education, skills training and support to informal caregivers of people with dementia and culturally adapted to Portugal by the Institute of Biomedical Sciences Abel Salazar and CINTESIS. Framed as a multi-component intervention, iSupport is grounded in problem-solving and cognitive behavioral therapy techniques. The program comprises 23 lessons on dementia and caregiver support distributed by 5 modules: 'Introduction to dementia'; 'Being a carer'; 'Caring for me'; 'Providing everyday care' and 'Dealing with behavior changes'. The education plan can be personalized by the caregiver and each lesson includes interactive exercises with immediate feedback; and positive messages as well as 'skills certificates' are displayed when lessons are completed. | Behavioural | iSupport for dementia - European-Portuguese version |
| e-book (comparator)The e-book contains information on relevant topics for dementia and caregiving, including basic information about dementia; practical tips on managing dementia; the changing needs of a person with dementia; dealing with care provision; caring for oneself (the caregiver) and finding emotional support; dealing with the death of the care receiver; relevant legislation (e.g. advance directives); how to get help; and how to reach the national Alzheimer's Association. | Other | Education-only e-book |
Primary outcome
Change from baseline in subjective burden using the Zarit Burden Interview (ZBI)
Time frame: Baseline, Month 3, Month 6
Caregiver burden measured with the Zarit Burden Interview (ZBI), Portuguese validated version, total score. The instrument comprises 22 items answered on a 5-point scale, ranging from 0 (never) to 4 (almost always) except for the final question on global burden, rated from 0 (not at all) to 4 (extremely). Total score for the ZBI ranges from 0 to 88 points, with higher scores indicating greater burden. The ZBI has good internal consistency (0.89), test-retest and interrater reliability as well as construct and concurrent validity, including reports of positive correlation with depression symptoms and time devoted to care provision. Regarding the psychometric properties of ZBI in Portugal, face, content, ecological, discriminant and convergent validity were documented, along with test-retest reliability (ICC= 0.93, CI95% 0.88 - 0.96, p < 0.001) and internal consistency (α = 0.88). The ZBI is one of the most used instruments to measure burden in intervention studies with caregivers.
4 secondary outcomes
Change from baseline in symptoms of depression and anxiety using the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, Month 3, Month 6
Change from baseline in quality of life using the WHOQOL-BREF
Time frame: Baseline, Month 3, Month 6
Change from baseline in Positive Aspects of Caregiving using the Positive Aspects of Caregiving (PAC)
Time frame: Baseline, Month 3, Month 6
Change from baseline in General self-efficacy using the Generalized self-efficacy scale
Time frame: Baseline, Month 3, Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 35232389Teles S, Ferreira A, Paul C. Feasibility of an online training and support program for dementia carers: results from a mixed-methods pilot randomized controlled trial. BMC Geriatr. 2022 Mar 1;22(1):173. doi: 10.1186/s12877-022-02831-z.
- Derived from this study: PubMed 31914936Teles S, Ferreira A, Seeher K, Freel S, Paul C. Online training and support program (iSupport) for informal dementia caregivers: protocol for an intervention study in Portugal. BMC Geriatr. 2020 Jan 8;20(1):10. doi: 10.1186/s12877-019-1364-z.
- Individual participant dataSharing planned: No
Related trials for Caregiver Subjective Burden
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Recruiting
Feasibility & Preliminary Impacts of an Online Psychoeducational Program (iSupport-Malaysia) for Informal Dementia Caregivers
Caregiver Subjective Burden, Caregiver Wellbeing
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.
Soraia T Sousa, M.S. principal investigator
Instituto de Ciências Biomédicas Abel Salazar - Universidade do Porto; CINTESIS
Constança Paúl, PhD study director
Instituto de Ciências Biomédicas Abel Salazar - Universidade do Porto; CINTESIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSupport for dementia - European-Portuguese version and e-book (comparator) in people with Caregiver Subjective Burden and Depressive Symptoms, run by Universidade do Porto at 1 site in Portugal.
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: paused, as of the sponsor's last update on 8 Nov 2022. 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 Portugal. 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?
Results are not available in the source record.
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 from baseline in subjective burden using the Zarit Burden Interview (ZBI) (time frame: Baseline, Month 3, Month 6). 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 NCT04104568, 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 8 Nov 2022.