Evaluating the effectiveness of a psychoeducational intervention for caregivers of individuals with acquired brain injury
| ISRCTN | ISRCTN16513116 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16513116 |
- Submission date
- 08/11/2023
- Registration date
- 12/12/2023
- Last edited
- 16/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Caring for a person with acquired brain injury (ABI) is stressful and could increase the risk of developing several health problems. A preventative measure such as a psychoeducational intervention could be useful to decrease the burden associated with caregiving. The main aim of this study is to assess the effectiveness of a psychoeducational intervention for caregivers of people with acquired brain injury (ABI).
Who can participate?
Informal caregivers of ABI patients
What does the study involve?
Participants are randomly allocated into two groups. One group receives the usual support from the day centres where the patient is being treated. The other group receives the same support plus a psychoeducative intervention of 10 sessions lasting 90-120 minutes. It includes information about the disease and training on different cognitive and behavioral skills. The study runs for 8 months. There are three assessment points at the start of the study and after 4 and 8 months.
What are the possible benefits and risks of participating?
Participants will benefit from a reduction in caregiver burden and better know-how about care skills and self-care. This study will be conducted with the highest regard for the safety and well-being of the participants. It is important to note that at no time were participants at any physical, emotional, or health risk by participating in the research. All procedures and activities were designed in such a way that they did not pose a danger to participants.
The only potential risk participants may experience will be discomfort from the time spent in the study. It is understood that their time is valuable, and there is concern about any inconvenience they may experience while participating in the different phases of the research. However, the study would like to express their appreciation for their contribution, as participation is essential to advance knowledge and understanding in this area of study.
Where is the study run from?
Aita Menni Hospital (Spain)
When is the study starting and how long is it expected to run for?
January 2011 to December 2019
Who is funding the study?
Sisters Hospitallers (Spain)
Who is the main contact?
Ana Isabel Domínguez Panchón, aidominguez.aitamenni@hospitalarias.es (Spain)
Contact information
Public, Scientific, Principal Investigator
Egaña Kalea, 10
Bilbao
48010
Spain
 ORCID ID |
0000-0002-4477-0029 |
|---|---|
| Phone | +34 944 43 49 27 |
| aidominguez.aitamenni@hospitalarias.es |
Study information
| Study design | Two-arm evaluator-blind multicentre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Care home |
| Study type | Prevention, Quality of life, Treatment, Efficacy |
| Participant information sheet | 44557_Caregiver_PIS [Spanish].pdf |
| Scientific title | Efficacy of a psychoeducative intervention program versus treatment as usual to prevent or reduce the burden associated with caring for a person with acquired brain injury: a two arm, evaluator blind, multicentre, randomized controlled trial |
| Study acronym | EDUCA-V |
| Study objectives | 1. The caregivers allocated to the psychoeducative intervention program will present less burden at the endpoint (4 months) and at follow-up (8 months) than those allocated to the control condition. 2. The caregivers allocated to the psychoeducative intervention program will present better mental health at the endpoint (4 months) and at follow-up (8 months) than the caregivers allocated to the control condition. 3. The caregivers allocated to the psychoeducative intervention program will present less anxiety at the endpoint (4 months) and at follow-up (8 months) than those allocated to the control condition. 4. The caregivers allocated to the psychoeducative intervention program will present less depression at the endpoint (4 months) and at follow-up (8 months) than those allocated to the control condition. |
| Ethics approval(s) |
Approved 10/10/2011, Ethical and Scientific Research Committee of Navarra (Pabellón de Docencia Recinto Hospital de Navarra Irunlarrea, 3, Pamplona, 31008, Spain; +34 848422495; ceic@cfnavarra.es), ref: 74/11 |
| Health condition(s) or problem(s) studied | The burden associated with acquired brain injury caregiving |
| Intervention | Randomization: The randomization process will be conducted in each research site using block randomization, with block sizes ranging from 1 to 4. The "Randomizer v. 0.4.0" module of Jamovi will be used to generate the sequence. The randomization process is blinded for all site investigators involved in the study. Only the central research committee had this information. The researchers responsible for evaluating the results were also blinded to the dyad assignment. Control group: Caregivers allocated to this group will receive the usual support from the day centre where the patients have multifaceted/multi-professional care aimed at improving or maintaining functional, social, and cognitive abilities for as long as possible. The caregiver will receive periodic interviews and information about the situation and clinical course of the patient. Intervention group: Caregivers allocated to this group are exposed to the same usual care the control group will receive plus a psychoeducative intervention program. This intervention is administered in 10 group sessions of 90-120 minutes each and the sessions were administered weekly. The caregiver will receive standardized information about the clinical course of schizophrenia and training on different cognitive and behavioral skills to increase care abilities, communicative skills, pleasant events, seeking support, and relaxation. |
| Intervention type | Behavioural |
| Primary outcome measure | Caregiver burden measured using the Zarit Burden Interview at baseline and 4 and 8 months |
| Secondary outcome measures | The following secondary outcome measures are assessed at baseline and 4 and 8 months: 1. Caregiver's mental health measured using the General Health Questionnaire, 28 items (GHQ-28) 2. Caregiver anxiety measured using the State-Trait Anxiety Inventory (STAI) 3. Caregiver depression measured using the Center for Epidemiologic Studies Depression Scale (CES-D) |
| Overall study start date | 01/01/2011 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 76 |
| Key inclusion criteria | Caregivers: 1. Aged 18 years old and over 2. Be caring for a person with acquired brain injury (ABI) (traumatic brain injury, stroke, anoxia, brain tumour or encephalitis) 3. Be an informal (unpaid) caregiver 4. Spend a minimum of 4 hours/week caring for the care-receiver Participants with ABI: 1. Aged 16 years old and over 2. Residents in the community 3. Receiving appropriate outpatient rehabilitation 4. Being stable clinically 5. Time since the ABI is more than 3 months |
| Key exclusion criteria | Caregivers: Those who did not have the time to attend the weekly sessions of intervention or had received a standardized intervention comparable to the one administered in the trial within the past year Participants with ABI: 1. Having been cared for in a respite care unit during the last 30 days 2. Living in professionally supervised housing |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 30/03/2019 |
Locations
Countries of recruitment
- Spain
Study participating centre
Bilbao
48010
Spain
Sponsor information
Hospital/treatment centre
Medical Director Manuel Martín Carrasco
C/ Egaña Kalea 10
Bilbao
48010
Spain
| Phone | +34 944 43 49 27 |
|---|---|
| mmartin.mennipamplona@hospitalarias.es | |
| Website | https://www.hospitalarias.es |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Ana I. Domínguez Panchón (aidominguez.aitamenni@hospitalarias.es). Quantitative and qualitative anonymized raw data will be shared for up to 5 years after the end of the trial. Consent from participants was required and obtained. Participants were informed about the aim of the study, the randomization process, the potential benefits of the intervention, the voluntary nature of participation, the anonymity of data processing, and the freedom to refuse their participation without stating reasons. A written informed consent was signed before their inclusion in the study. Data anonymisation was performed using dissociated data (using an internal and unique code for each participant). The study procedures were carried out in agreement with the Declaration of Helsinki. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 29/11/2023 | No | Yes | ||
| Participant information sheet | 29/11/2023 | No | Yes | ||
| Results article | 12/09/2024 | 16/09/2024 | Yes | No |
Additional files
Editorial Notes
16/09/2024: Publication reference added.
29/11/2023: Study's existence confirmed by Hermanas Hospitalarias (Spain).
