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Completed

NCT Number: NCT04036955

Evaluation of an Innovative Information, Training and Social Support Intervention "INFOSADEM" to Principal Caregivers of Dementia Patients Living at Home

Background: Dementia is an illness that mostly affects people of advanced age and causes disability and dependency. Although the difficulties, a vast number of older people with dementia at our context, are cared for in their own homes by a family member, usually their spouse/partner, son, daughter or companion, but it is well known that this could be one of the main factors of institutionalization. However, home care is an effective option for the health system. This care may be provided over months or years and can have negative effects on the caregivers' health. This article describes the development and implementation of a structured, psychoeducational intervention addressed to informal caregivers of people with dementia cared for at home.

Methods: A quasi-experimental study with repeated observations at 3 and 6 months post-intervention was performed. Intentional sampling and convenience assignment method was used for intervention and control groups. The intervention was structured developed at the beginning of the study, which consists of a multicomponent training, information and emotional support programme of five, 90-minute sessions over one week. The control group received Usual Care. The project was approved by the ethics committee (HCB/2014/0317) and follows the recommendations of the Declaration of Helsinki. Evidence gathered from our research will be published at national and international level.

Discussion: The results of this intervention will support other studies and contribute scientific evidence on the importance of promoting non-pharmacologic interventions in informal caregivers of people with dementia. At the same time, they can be used as the basis for the implementation of psycho educational interventions in home care and in long-term care institutions responsible for monitoring people with dementia; responding to training and information needs, and providing the social support that the caregivers themselves demand.

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • Eligibility Criteria People with a diagnose of dementia, living at home and having an informal caregiver.

Inclusion criteria

  • People with a diagnose of dementia
  • People older than 65 years old
  • Living at home and receiving public formal care* from Primary Health Care centers.
  • Having an informal caregiver** identified being capable of understand healthcare professional advices (this will be measured by healthcare professional criteria).
  • Cognitive level having a MMSE score lower of 24 .
  • Informed consent signed. *We considered public formal care, the health care team working on Primary Care (being home care or primary care) (GPs,Registered Nurse, Social Worker).
  • We considered informal caregiver the person (family or not) who takes care of the PwD and lives together or visit him/her at least three times a week.

Exclusion criteria

  • People lower than 65 years old
  • People with a psychiatric symptom or Korsakov sindrome
  • People without informal caregiver identified
  • Outcome measures
  • preparation for care through the Preparedness for Caregiving Scale (PCS)
  • Perceived Competence Scale for Care
  • Inventory Family needs
  • Zarit Burden Scale
  • Katz Index of Independence in Activities of Daily Living
  • positive and negative aspects of care with the Caregiver Reaction assessment (CRA)
  • Perceived Social Support Questionnaire (Duke-UNK )
  • Quality of Life Scale (EQ-5D)
  • General Health Questionnaire (GHQ-12)
  • Resource Utilization Questionnaire for dementia (RUD)
  • Neuropsychiatric Inventory (NPI) .
  • Quality of Life in Alzheimer's Disease (QoL-AD)
  • Charlson Comorbidity Index (CCI)
  • Mini-Mental State Examination (MMSE)
  • Global Deterioration Scale (GDS)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People with a diagnose of dementia
  • People older than 65 years old
  • Living at home and receiving public formal care* from Primary Health Care centers.
  • Having an informal caregiver** identified being capable of understand healthcare professional advices (this will be measured by healthcare professional criteria).
  • Cognitive level having a MMSE score lower of 24 .
  • We considered public formal care, the health care team working on Primary Care (being home care or primary care) (GPs, Registered Nurse, Social Worker). **We considered informal caregiver the person (family or not) who takes care of the PwD and lives together or visit him/her at least three times a week.

Exclusion criteria

  • People lower than 65 years old
  • People with a psychiatric symptom or Korsakov sindrome
  • People without informal caregiver identified

Treatment and study plan

INFOSA-DEM

Other

Caregivers in the intervention group received the INFOSA-DEM programme, together with usual care provided by the participating centres, while caregivers in the CG received usual care in the centres where the follow-up was carried out.

Primary outcomes

  1. Preparedness for Caregiving

    Time frame: 2 years

    Preparedness for Caregiving Scale (PCS; 8 items): Assess readiness for tasks and demands of caregiving role. Domains include providing physical care, providing emotional support, setting up in-home support services and deling with the stress of caregiving. Participants are asked to identified how well prepared they feel on a scale from not all prepared (0) to very well prepared (4). Cronbach's Alpha: 0.88-93

  2. positive and negative aspects of care

    Time frame: 2 years

    . Caregiver Reaction Aspects (CRA; 24 items): consists of 24 items in five subscales: self-esteem (range 7-35), lack of family support (range 5-25), financial problems (range 3-15), disrupted schedule (range 5-25) and health problems (range 4-20).

  3. perceived social support

    Time frame: 2 years

    Perceived Social Support Questionnaire (Duke-UNK; 8 items): Instrument to measure the strength of the person's social support network. Cronbach's Alpha: 0.88.

  4. Level of Quality of life: EQ-5D

    Time frame: 2 years

    Quality of Life Scale (EQ-5D): a measure of self-reported quality of life that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Cronbach's Alpha: 0.87.

  5. FAMILY NEEDS

    Time frame: 2 years

    Family needs inventory

  6. level of burden

    Time frame: 2 years

    Zarit Burden Scale (ZBS; 22 items): a questionnaire developed to measure subjective burden among caregivers. Cronbach's Alpha: 0.92.

  7. Neuropsychiatric Inventory (NPI)

    Time frame: 2 years

    Assess dementia-related behavioral symptoms. Is composed by 10 sub-domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, deshinibition, irritability/liability, and aberrant motor activity. Cronbach's Alpha:0.88

  8. degree of independence in activities of daily living

    Time frame: 2 years

    Katz index of Activity of Daily Living (KATZ; 5 items): to assess an older adult's baseline ability to bathe, dress, use the toilet, transfer, remain continent, and feed her- or himself. It's also used for evaluating changes in response to illness. Cronbach's Alpha: 0.87

  9. Competence for care

    Time frame: 2 years

    The Perceived Competence Scale for Care

Other outcomes

  1. level of cognitive deterioration

    Time frame: 2 years

    Global Deterioration Scale (GDS): provides caregivers an overview of the stages of cognitive function for those suffering from a primary degenerative dementia such as Alzheimer's disease. It is broken down into 7 different stages. Stages 1-3 are the pre-dementia stages. Stages 4-7 are the dementia stages. Beginning in stage 5, an individual can no longer survive without assistance.

  2. Comorbidity

    Time frame: 2 years

    Charlson Comorbidity Index (CCI): Assess multiple comorbidity. To complete the Index, patients are asked whether they have a history of medical problems in 12 areas. Among patients with chronic medical conditions, the Index categories were predictive of 1-year mortality and health care costs. Cronbach's Alpha: 0.96.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Fundació La Marató de TV3

Registry information

Official study title

Evaluation of an Innovative Information, Training and Social Support Intervention "INFOSADEM" to Principal Caregivers of Dementia Patients Living at Home. Experimental Study

Acronym: INFOSA-DEM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2019
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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