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Effectiveness of iSupport for unpaid carers of people with dementia: a randomised controlled trial.

Effectiveness of iSupport for unpaid carers of people with dementia: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28037
Enrollment
200
Registered
2017-06-27
Start date
2019-01-22
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dementia, informal caregivers intervention, online support programme, e-health intervention

Interventions

The trial contains two arms: (1) iSupport and (2) a comparison group which will receive a minimal intervention which consists of psycho-education about dementia. -iSupport: iSupport is an online s
Being a caregiver (4 lessons)
Caring for Me (3 lessons)
Providing everyday care (5 lessons), and
Dealing with Challenging Behaviour (10 lessons). Each caregiver can choose which lessons they like to do, depending on their needs, and when they like to complete them. The program will be available

Sponsors

Faculty of Behavioural and Movement Sciences, VU University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1) Be aged 18 years or older; 2) Be an unpaid carer (partners, children, friends, etc) of a person with dementia for at least 6 months and experience at least some caregiver burden. This is assessed with one item on which the person can score the burden between 1 (no burden) and 10 (extreme burden). People with a score of 4 or higher will be included; 3) Well-being needs to be affected and might be expressed as stress, depressive symptoms or anxiety. This mean that people need to have a score of > 13 on the Perceived Stress Scale (PSS14) or a score ≥4 on the Hospital Anxiety and Depression Scale, anxiety subscale (HADS-A)), or a score ≥4 on the Centre for Epidemiological Studies Depression scale (CES-D); 4) The care recipient has to have a confirmed diagnosis of dementia (through self-report of the caregiver) or a score ≥2 on the Ascertain Dementia 8-item Informant Questionnaire (AD8).

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1) Those receiving psychological treatment from a mental health specialist at the time of recruitment; 2) Being unable to comprehend written Dutch; 3) No access to internet.

Design outcomes

Primary

MeasureTime frame
The main study parameter will be caregivers’ stress at post-intervention. This will be measured with the Perceived Stress Scale (PSS14).

Secondary

MeasureTime frame
The secondary study parameters can be grouped into three categories. First, mental health outcomes. This includes: symptoms of depression (Centre for Epidemiological Studies Depression scale (CES-D)), symptoms of anxiety (Hospital anxiety and depression scale, anxiety sub-scale (HADS-A)), and caregiver burden (Zarit Burden Scale (ZBS). The second category of outcomes relate to the way caregivers perceive that they can cope with the situation and the person with dementia. It includes: general sense of mastery (Pearlin Mastery Scale), self-efficacy (RIS) which relate to the feeling that one can perform a certain task in a given situation competently and capably, sense of competence (Short Sense of Competence Questionnaire (SSCQ)) of the caregiver to care for the person with dementia, and the way the caregiver approaches the person with dementia (ADQ) which measures specifically if the caregiver can see the person with dementia as a unique and valuable person. The third category consists of usability (System usability scale (SUS)) which evaluates the satisfaction about the intervention as a whole. Next to this we will measure satisfaction with every lesson but this is incorporated into the intervention itself. Finally, we will gather data about the number of logins and the time spend on the intervention as indicators of intervention adherence.

Contacts

Public ContactÁngel C. Pinto Bruno

Faculty of Behavioural and Movement Sciences (VU Amsterdam)

a.c.pintobruno@vu.nl+31205986727

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)