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Educational intervention in primary caregivers of dependent persons on the prevention of dependency-related skin lesions

- P: People at risk for dependency-related skin lesions and their primary caregivers. - I: Training of caregivers of people at risk of suffering from dependency-related skin lesions (CRLD) through an educational nursing program in the prevention of these lesions based on a nursing group educational support system within the framework of care for chronicity and dependency. Direct intervention that involves an indirect intervention in people at risk of suffering CRLD. - C: Caregivers of persons at risk for CRLD receive standardized individual advice from their referring nurse. - O: Reduce the occurrence of dependency-related skin lesions in dependent persons.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11911802
Enrollment
93
Registered
2024-05-11
Start date
2023-12-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Prevention of skin lesions related to dependence Skin and Connective Tissue Diseases

Interventions

This study will analyze the effectiveness of an educational program based on a nursing group educational support system for caregivers in the prevention of skin lesions related to dependence in terms
CRLD), knowledge index, health-related quality of life, and caregiver overload will be assessed at 0, 1, 3 and 6 months after having received the sessions. Before starting the intervention, the valida

Sponsors

University of Valencia
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Patients at risk of developing CRLD according to the Braden scale for the prediction of pressure ulcer risk available in Selene AP (Selene®). 2. Primary caregiver identified 3. Sufficient knowledge in terms of understanding, reading and writing correctly in Spanish 4. The caregiver has received standardized CRLD prevention training provided by their referring nurse or research team

Exclusion criteria

Exclusion criteria: 1. Occasional or secondary caregivers who are not primary caregivers, i.e., who do not assume full responsibility for the caregiving task 2. Caregivers who do not speak Spanish 3. Caregivers who present cognitive impairment or learning difficulties 4. Caregivers who are not sufficiently independent for basic activities of daily living (ABVD) and have a Barthel index = 60

Design outcomes

Primary

MeasureTime frame
Effectiveness assessed via the incidence of injuries, and appearance of skin lesions (i.e., pressure and/or shear injuries, skin lesions associated with moisture, friction injuries, skin tears and a mixture of combined injuries) related to dependence by a referring nurse or the principal investigator measured using the collected data at 0, 1, 3 and 6 months

Secondary

MeasureTime frame
Current key secondary outcome(s) as of 25/03/2026: The following secondary outcome measures will be assessed at 0, 1, 3 and 6 months: 1. Knowledge of dependence-related skin lesions in caregivers of persons at risk for CRLD measured using the Questionnaire of knowledge of family caregivers about prevention of pressure ulcer and dependence-related skin lesions (COCU-LCRD-23) in Spanish 2. Health-related quality of life (HRQoL) of caregivers of persons at risk for CRLD measured using the EuroQol EQ-5D-5L HRQoL questionnaire 3. Emotional overload of caregivers of persons at risk for CRLD measured using the Zarit Burden Interview assessing caregiving burden _____ Previous key secondary outcome(s): The following secondary outcome measures will be assessed at 0, 1, 3 and 6 months: 1. Knowledge of dependence-related skin lesions in caregivers of persons at risk for CRLD measured using the Questionnaire of knowledge of family caregivers about prevention of pressure ulcer and dependence-related skin lesions (COCU-LCRD-23) in Spanish 2. Health-related quality of life (HRQoL) of caregivers of persons at risk for CRLD measured using the EuroQol EQ-5D-5L HRQoL questionnaire 3. Emotional overload of caregivers of persons at risk for CRLD measured using the Zarit Burden Interview assessing caregiving burden 4. Post-intervention costs of caring for people at risk of developing dependence-related skin lesions measured using pricing data stipulated by Riojano Health Service for nursing consultation, nursing home and cure material 5. Cost-utility analysis (CUA) of a health education intervention for the prevention of dependence-related skin lesions measured using data recorded in medical records

Countries

Spain

Contacts

Public ContactPablo García Molina
pagarmo3@uv.es+34651407310

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026