Group Intervention Empowerment Dementia
Primary Purpose
Empowerment, Self Efficacy, Quality of Life
Status
Unknown status
Phase
Early Phase 1
Locations
Argentina
Study Type
Interventional
Intervention
empowerment
usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Empowerment focused on measuring Self-management, Caregiving, Quality of life, Empowerment
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
Sites / Locations
- Faculty of Psychology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
empowerment group
no treatment group
Arm Description
empowerment intervention by us for us guides
dementia patients treatment as usual
Outcomes
Primary Outcome Measures
patients' HRQoL (15D)
patients' HRQoL (15D)
Secondary Outcome Measures
caregivers' psychological well-being (GHQ-12)
caregivers' psychological well-being (GHQ-12)
caregivers sense of competence (SCQ).
sense of self fulfillment and accomplishment in providing care to dementia patients
spousal caregivers' HRQoL (RAND-36)
spousal caregivers' HRQoL (RAND-36)
Full Information
NCT ID
NCT02391766
First Posted
February 4, 2014
Last Updated
March 17, 2015
Sponsor
Universidad Nacional de Rosario
1. Study Identification
Unique Protocol Identification Number
NCT02391766
Brief Title
Group Intervention Empowerment Dementia
Official Title
Psychosocial Group Intervention to Enhance Empowerment of People With Dementia and Their Caregivers: Study Protocol for a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional de Rosario
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Empowerment, Self Efficacy, Quality of Life
Keywords
Self-management, Caregiving, Quality of life, Empowerment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
empowerment group
Arm Type
Active Comparator
Arm Description
empowerment intervention by us for us guides
Arm Title
no treatment group
Arm Type
Placebo Comparator
Arm Description
dementia patients treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
empowerment
Other Intervention Name(s)
by us for us guides
Intervention Description
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
Intervention Name(s)
usual care
Primary Outcome Measure Information:
Title
patients' HRQoL (15D)
Description
patients' HRQoL (15D)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
caregivers' psychological well-being (GHQ-12)
Description
caregivers' psychological well-being (GHQ-12)
Time Frame
8 weeks
Title
caregivers sense of competence (SCQ).
Description
sense of self fulfillment and accomplishment in providing care to dementia patients
Time Frame
8 weeks
Title
spousal caregivers' HRQoL (RAND-36)
Description
spousal caregivers' HRQoL (RAND-36)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
56 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
daniel serrani
Organizational Affiliation
Universidad Nacional de Rosario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Psychology
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
Group Intervention Empowerment Dementia
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