Dependent Older PeopleNCT06326151
Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults
A study testing Interdisciplinary Psychoeducational Programme and Health Education Programme in people with Dependent Older People and Family Caregiver, run by University of Salamanca at 1 site in Spain.
Trial summary
Background: Caring for an older dependent adult with cognitive impairment can have negative consequences for the family caregiver. Interdisciplinary interventions are necessary to address their needs jointly and comprehensively. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dependent Older People, Family Caregiver, Interdisciplinary
- What is being tested?
- Interdisciplinary Psychoeducational Programme and Health Education Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 31 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be the primary family caregiver of a person with cognitive impairment (Mini Mental State Examination (MMSE) < 24 points in a situation of moderate or severe dependency (Barthel) ≤ 55
- Be aged 60 years or older; have been the primary family caregiver for one year or more
- Voluntarily sign the consent form to participate and complete the initial assessment.
Who cannot join
- Lack of literacy or significant deficits in language comprehension and being a formal carer -
- Receiving financial remuneration for caring for the sick person.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Eduardo Jose Fernandez Rodriguez
Salamanca, Castille and León, 37002
Eduardo PhD Fernandez, PhD, 923294500, edujfr@usal.es
About this study
Official title: Study for a Randomised Controlled Trial: Effect of an Interdisciplinary Psycho-educational Intervention Programme on Caregivers of Dependent Older Adults
Background: Caring for an older dependent adult with cognitive impairment can have negative consequences for the family caregiver. Interdisciplinary interventions are necessary to address their needs jointly and comprehensively. While attempts have been made to improve their situation from different disciplines in isolation, a collaborative approach is required to ensure the best possible outcome.
Methods: A parallel, randomized, controlled clinical trial with two arms will be conducted at the Occupational Therapy Teaching and Care Unit (UDATO) and the Municipal Psychosocial Support Unit for the Elderly (UMAPS), both of which belong to the University of Salamanca and are in agreement with the City Council of Salamanca, Spain. The trial will also be conducted at the University Care Centre of Salamanca (CAUSA). People aged 60 years or older will be recruited as family caregivers of dependent older adults with cognitive impairment in a chronic situation. Participants will be divided into two groups: the intervention group (IG) will carry out an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy, and the control group (CG) will carry out a controlled follow-up. Participants will complete 12 sessions over a period of 3 months, followed by three monthly reinforcement sessions after the intervention. At the beginning and end of the intervention, participants will be assessed and socio-demographic data will be collected along with the following scales: the Spanish version of the Caregiver Burden Interview (CBI), the Spanish version of the Center for Epidemiologic Studies-Depression Scale (CES-D), the Psychosocial Support Questionnaire adaptation (PSQ), the General Health Questionnaire (GHQ), the World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE) and the Bayer-Activities of Daily Living Scale (B-ADL).
Discussion: The objective of this study is to enhance conventional clinical practice for family caregivers of dependent older adults. This will be achieved through an interdisciplinary psychoeducational intervention that aims to reduce overload and depressive symptomatology, increase social support, improve health and perceived quality of life, and enhance understanding of the syndrome/illness. The intervention will also focus on managing difficult situations associated with day-to-day caregiving, managing emotions and associated erroneous beliefs, and promoting self-care. Additionally, the study aims to improve the functionality of the cared-for person.
- Conditions
- Dependent Older People, Family Caregiver, Interdisciplinary, Intervention, Occupational Therapy, Psychoeducational
- Being tested
- Interdisciplinary Psychoeducational Programme, Health Education Programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary Psychoeducational ProgrammeBehavioural
This intervention is based on the principle of complementing and integrating both disciplines in order to meet the psychological needs of family carers and to train them in knowledge and strategies aimed at the correct performance of activities of daily living in order to promote the maximum autonomy and functionality of dependent people with cognitive impairment, and that this favours discharge, self-care, improvement of the affective state and quality of life of family carers.
Health Education ProgrammeBehavioural
Upon discharge from the hospital, at the end of the baseline assessment, caregivers will receive instructions and recommendations for maintaining an active and healthy lifestyle. This will be done by encouraging self-care and good practices in caring for their dependent family member, as part of a health education programme. The benefits of an active lifestyle and general guidelines are emphasized.
| Study group | Role | What they receive |
|---|---|---|
| Health Education Programme | Active comparator | Why: Upon discharge from the hospital, at the end of the baseline assessment, caregivers will receive instructions and recommendations for maintaining an active and healthy lifestyle. This will be done by encouraging self-care and good practices in caring for their dependent family member, as part of a health education programme. The benefits of an active lifestyle and general guidelines are emphasized.
What (materials): Instructions and recommendations for a health education programme.
What (procedures): Participants will receive instructions and recommendations on how to maintain an active and healthy lifestyle, promoting self-care and good practices in caring for their dependent family member.
How: The caregiver will receive the material individually at the time of referral, before being discharged from the hospital.
When and for how long: The intervention consists of a single session and details of the time and duration will be provided to participants. Receives: Behavioral: Health Education Programme |
| Interdisciplinary Psychoeducational Programme | Experimental | Why: The programme is based on an interdisciplinary psychoeducational intervention from the fields of occupational therapy and psychology.
What (materials): projector, computer, screen, presentation of content, stationery, chairs, tables and self-recording of home tasks.
What (procedures): Patients assigned to the experimental group will follow an interdisciplinary psychoeducational programme structured and supervised at the University of Salamanca, consisting of a health education programme combined with an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy.
Who will carry out the interventions: modules: (I) understanding the syndrome or disease and managing difficult everyday caring situations or behaviours, (II) emotions and misconceptions about caring, and (III) self-care (Table 1).
When and for how long: Each participant will receive 4 sessions per month for 3 months, for a total of 12 sessions. Receives: Behavioral: Interdisciplinary Psychoeducational Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination (MMSE)
temporal and spatial orientation, fixation, attention and arithmetic, memory, nomination, repetition, comprehension, reading, writing and drawing.
Measured: Baseline; "3 months follow up"; "up to 24 weeks"
Barthel Index
degree of dependency in activities of daily living
Measured: Baseline; "3 months follow up"; "up to 24 weeks"
Caregiver Burden Interview
perceived overload
Measured: Baseline; "3 months follow up"; "up to 24 weeks"
Secondary outcomes (5)
Centre for Epidemiological Studies Depression Scale
depressive symptoms
Measured: Baseline; "3 months follow up"; "up to 24 weeks"
Adaptation of the Psychosocial Support Questionnaire
perceived psychosocial support
Measured: Baseline; "3 months follow up"; "up to 24 weeks"
General Health Questionnaire
perceived health
Measured: Baseline; "3 months follow up"; "up to 24 weeks"
World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE)
Quality of Life
Measured: Baseline; "3 months follow up"; "up to 24 weeks"
The Bayer-Activities of Daily Living Scale (B-ADL)
functional disabilities in elderly patients with mild to moderate dementia or cognitive impairment
Measured: Baseline; "3 months follow up"; "up to 24 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Dependent Older PeopleStudies 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
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Eduardo J Fernández Rodríguez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326151
- Sponsor's protocol ID
- UMAPS-UDATO
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: They will be made available to researchers in the document repository "GREDOS" of the University of Salamanca, Spain.
Publications
Garcia-Tizon SJ, Gomez CS, Martinez MBB, Prados ABN, Rodriguez EJF. Study protocol for a randomised controlled trial: effect of an interdisciplinary psycho-educational intervention programme on caregivers of dependent older adults. BMC Geriatr. 2025 Aug 30;25(1):674. doi: 10.1186/s12877-025-06305-w.
PubMed 40885892
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for a Randomised Controlled Trial: Effect of an Interdisciplinary Psycho-educational Intervention Programme on Caregivers of Dependent Older Adults
- ClinicalTrials.gov ID
- NCT06326151
- Acronym / sponsor ID
- UMAPS-UDATO
- Conditions
- Dependent Older People, Family Caregiver, Interdisciplinary, Intervention, Occupational Therapy, Psychoeducational
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Mar 2024 (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: Caring for an older dependent adult with cognitive impairment can have negative consequences for the family caregiver. Interdisciplinary interventions are necessary to address their needs jointly and comprehensively. While attempts have been made to improve their situation from different disciplines in isolation, a collaborative approach is required to ensure the best possible outcome.
Methods: A parallel, randomized, controlled clinical trial with two arms will be conducted at the Occupational Therapy Teaching and Care Unit (UDATO) and the Municipal Psychosocial Support Unit for the Elderly (UMAPS), both of which belong to the University of Salamanca and are in agreement with the City Council of Salamanca, Spain. The trial will also be conducted at the University Care Centre of Salamanca (CAUSA). People aged 60 years or older will be recruited as family caregivers of dependent older adults with cognitive impairment in a chronic situation. Participants will be divided into two groups: the intervention group (IG) will carry out an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy, and the control group (CG) will carry out a controlled follow-up. Participants will complete 12 sessions over a period of 3 months, followed by three monthly reinforcement sessions after the intervention. At the beginning and end of the intervention, participants will be assessed and socio-demographic data will be collected along with the following scales: the Spanish version of the Caregiver Burden Interview (CBI), the Spanish version of the Center for Epidemiologic Studies-Depression Scale (CES-D), the Psychosocial Support Questionnaire adaptation (PSQ), the General Health Questionnaire (GHQ), the World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE) and the Bayer-Activities of Daily Living Scale (B-ADL).
Discussion: The objective of this study is to enhance conventional clinical practice for family caregivers of dependent older adults. This will be achieved through an interdisciplinary psychoeducational intervention that aims to reduce overload and depressive symptomatology, increase social support, improve health and perceived quality of life, and enhance understanding of the syndrome/illness. The intervention will also focus on managing difficult situations associated with day-to-day caregiving, managing emotions and associated erroneous beliefs, and promoting self-care. Additionally, the study aims to improve the functionality of the cared-for person.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education Programme | Active comparator | Behavioral: Health Education ProgrammeWhy: Upon discharge from the hospital, at the end of the baseline assessment, caregivers will receive instructions and recommendations for maintaining an active and healthy lifestyle. This will be done by encouraging self-care and good practices in caring for their dependent family member, as part of a health education programme. The benefits of an active lifestyle and general guidelines are emphasized. What (materials): Instructions and recommendations for a health education programme. What (procedures): Participants will receive instructions and recommendations on how to maintain an active and healthy lifestyle, promoting self-care and good practices in caring for their dependent family member. How: The caregiver will receive the material individually at the time of referral, before being discharged from the hospital. When and for how long: The intervention consists of a single session and details of the time and duration will be provided to participants. |
| Interdisciplinary Psychoeducational Programme | Experimental | Behavioral: Interdisciplinary Psychoeducational ProgrammeWhy: The programme is based on an interdisciplinary psychoeducational intervention from the fields of occupational therapy and psychology. What (materials): projector, computer, screen, presentation of content, stationery, chairs, tables and self-recording of home tasks. What (procedures): Patients assigned to the experimental group will follow an interdisciplinary psychoeducational programme structured and supervised at the University of Salamanca, consisting of a health education programme combined with an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy. Who will carry out the interventions: modules: (I) understanding the syndrome or disease and managing difficult everyday caring situations or behaviours, (II) emotions and misconceptions about caring, and (III) self-care (Table 1). When and for how long: Each participant will receive 4 sessions per month for 3 months, for a total of 12 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be the primary family caregiver of a person with cognitive impairment (Mini Mental State Examination (MMSE) < 24 points in a situation of moderate or severe dependency (Barthel) ≤ 55
- Be aged 60 years or older; have been the primary family caregiver for one year or more
- Voluntarily sign the consent form to participate and complete the initial assessment.
Key exclusion criteria (2 listed)
- Lack of literacy or significant deficits in language comprehension and being a formal carer -
- Receiving financial remuneration for caring for the sick person.
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 |
|---|---|---|
| Interdisciplinary Psychoeducational ProgrammeThis intervention is based on the principle of complementing and integrating both disciplines in order to meet the psychological needs of family carers and to train them in knowledge and strategies aimed at the correct performance of activities of daily living in order to promote the maximum autonomy and functionality of dependent people with cognitive impairment, and that this favours discharge, self-care, improvement of the affective state and quality of life of family carers. | Behavioural | Interdisciplinary Psychoeducational Programme |
| Health Education ProgrammeUpon discharge from the hospital, at the end of the baseline assessment, caregivers will receive instructions and recommendations for maintaining an active and healthy lifestyle. This will be done by encouraging self-care and good practices in caring for their dependent family member, as part of a health education programme. The benefits of an active lifestyle and general guidelines are emphasized. | Behavioural | Health Education Programme |
Primary outcome
Mini Mental State Examination (MMSE)
Time frame: Baseline; "3 months follow up"; "up to 24 weeks"
temporal and spatial orientation, fixation, attention and arithmetic, memory, nomination, repetition, comprehension, reading, writing and drawing.
Barthel Index
Time frame: Baseline; "3 months follow up"; "up to 24 weeks"
degree of dependency in activities of daily living
Caregiver Burden Interview
Time frame: Baseline; "3 months follow up"; "up to 24 weeks"
perceived overload
5 secondary outcomes
Centre for Epidemiological Studies Depression Scale
Time frame: Baseline; "3 months follow up"; "up to 24 weeks"
Adaptation of the Psychosocial Support Questionnaire
Time frame: Baseline; "3 months follow up"; "up to 24 weeks"
General Health Questionnaire
Time frame: Baseline; "3 months follow up"; "up to 24 weeks"
World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE)
Time frame: Baseline; "3 months follow up"; "up to 24 weeks"
The Bayer-Activities of Daily Living Scale (B-ADL)
Time frame: Baseline; "3 months follow up"; "up to 24 weeks"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 40885892Garcia-Tizon SJ, Gomez CS, Martinez MBB, Prados ABN, Rodriguez EJF. Study protocol for a randomised controlled trial: effect of an interdisciplinary psycho-educational intervention programme on caregivers of dependent older adults. BMC Geriatr. 2025 Aug 30;25(1):674. doi: 10.1186/s12877-025-06305-w.
- Individual participant dataSharing planned: Yes. They will be made available to researchers in the document repository "GREDOS" of the University of Salamanca, Spain.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary Psychoeducational Programme and Health Education Programme in people with Dependent Older People and Family Caregiver, run by University of Salamanca 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental State Examination (MMSE) (time frame: Baseline; "3 months follow up"; "up to 24 weeks"). The study lists 3 primary outcomes in all. 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 NCT06326151, 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 22 Mar 2024.