Group Intervention Empowerment Dementia

NCT ID: NCT02391766

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-10-31

Brief Summary

After diagnosis of a dementing illness, patients and their spouses have many concerns related to the disease and their future. This often leads to poor psychological well-being and reduced health-related quality of life (HRQoL) of the family. Support for Empowerment has been proven to be an effective method to improve prognosis of asthma, heart failure, osteoarthritis.and diabetes. However empowering interventions have not been studied in dementia. Therefore, the investigators aim was to examine, in an objective-oriented group intervention, the efficacy of empowerment support program (ESP) on the HRQoL of dementia patients and their spousal caregivers as well as on the sense of competence and psychological well-being of caregivers.

Methods: During the years 2014 to 15, 180 dementia patients and their spouses will be recruited from memory clinics or day centers and randomized into two arms: 90 patients for group-based ESP sessions including topics selected by the participants and the use of the by us for us guides, 90 patients will serve as controls in usual community care. Sessions may include topics on dementia, active lifestyle and prevention for cognitive decline, spousal relationship, future planning and emotional well-being. The patients and spouses will have their separate group sessions (ten participants per group) once a week for eight weeks.

Detailed Description

Diagnoses and medications are confirmed from medical records provided by the couples. Charlson's comorbidity index is calculated to assess the severity and prognostic value of the participants' disease burden . Health-related quality of life (HRQoL) of the patients is assessed by using the 15D instrument Dementia patients are also assessed with the Clinical Dementia Rating Scale (CDR) the Mini Mental State Examination (MMSE) Other measurements include activities of daily living (ADL), instrumental activities of daily living (IADL) The presence of advance directives, such as a living will, are inquired about. Clinical measurements include height, weight, blood pressure and hand grip strength. The spousal caregivers are asked questions concerning the impact of their spouse's dementia diagnosis and they are assessed by the RAND-36 HRQoL instrument, 12-item General Health Questionnaire (GHQ-12) the Center for Epidemiologic Studies Depression Scale (CES-D) the randomization is performed by telephone to a randomization center. Couples are randomly allocated by means of computer-generated random numbers. Every randomization result will appear in the program after the participants name has been written and the person executing the randomization has confirmed the process with her initials. Participating couples are assessed by two study nurses three times over nine months: at baseline, three, and nine months. Use of health services, institutionalizations and mortality of both patients and caregivers will be retrieved from the central registers until 24 months from the baseline measurements.

Conditions

Empowerment; Self Efficacy; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

empowerment group

empowerment intervention by us for us guides

Group Type: ACTIVE_COMPARATOR

empowerment

Intervention Type: BEHAVIORAL

The groups of 10 participants meet once a week for eight weeks. last for four hours

topics on dementia and prevention of further cognitive decline, active lifestyle and emotional well-being, spousal relationship, future planning kinds of active learning used are working in pairs and brainstorming sessions.

no treatment group

dementia patients treatment as usual

Group Type: PLACEBO_COMPARATOR

usual care

Intervention Type: BEHAVIORAL

Interventions

empowerment

The groups of 10 participants meet once a week for eight weeks. last for four hours

topics on dementia and prevention of further cognitive decline, active lifestyle and emotional well-being, spousal relationship, future planning kinds of active learning used are working in pairs and brainstorming sessions.

Intervention Type: BEHAVIORAL

usual care

Intervention Type: BEHAVIORAL

Other Intervention Names

by us for us guides

Eligibility Criteria

Inclusion Criteria

• patients with dementia
• home dwelling with spouse
• not in the terminal phase of illness (estimated prognosis > one year)
• able to move independently (with or without devise)
• no severe hearing loss

Exclusion Criteria

• neurological disease
• other medical conditions
• head trauma
• inability to move independently

• Minimum Eligible Age: 56 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Nacional de Rosario

OTHER

Sponsor Role: lead

Responsible Party

daniel serrani

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

daniel serrani

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional de Rosario

Locations

Faculty of Psychology

Rosario, Santa Fe Province, Argentina

Countries

Argentina

Other Identifiers

´GIED01

Identifier Type: REGISTRY

Identifier Source: secondary_id

PGIED01

Identifier Type: -

Identifier Source: org_study_id