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

Dementia Clinical Trial

— INFOSA-DEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036955
• Other study ID #: HCB/2014/0317
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. 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

2. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• INFOSA-DEM
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Fundació La Marató de TV3

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	level of cognitive deterioration	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 years
Other	Comorbidity	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.	2 years
Primary	Preparedness for Caregiving	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 years
Primary	positive and negative aspects of care	. 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).	2 years
Primary	perceived social support	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.	2 years
Primary	Level of Quality of life: EQ-5D	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.	2 years
Primary	FAMILY NEEDS	Family needs inventory	2 years
Primary	level of burden	Zarit Burden Scale (ZBS; 22 items): a questionnaire developed to measure subjective burden among caregivers. Cronbach's Alpha: 0.92.	2 years
Primary	Neuropsychiatric Inventory (NPI)	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	2 years
Primary	degree of independence in activities of daily living	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	2 years
Primary	Competence for care	The Perceived Competence Scale for Care	2 years