Group Intervention Empowerment Dementia

March 17, 2015 updated by: daniel serrani, Universidad Nacional de Rosario

Psychosocial Group Intervention to Enhance Empowerment of People With Dementia and Their Caregivers: Study Protocol for a Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Faculty of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: empowerment group
empowerment intervention by us for us guides
Behavioral: 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.

Other Names:
  • by us for us guides
Placebo Comparator: no treatment group
dementia patients treatment as usual
Behavioral: usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients' HRQoL (15D)
Time Frame: 8 weeks
patients' HRQoL (15D)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
caregivers' psychological well-being (GHQ-12)
Time Frame: 8 weeks
caregivers' psychological well-being (GHQ-12)
8 weeks
caregivers sense of competence (SCQ).
Time Frame: 8 weeks
sense of self fulfillment and accomplishment in providing care to dementia patients
8 weeks
spousal caregivers' HRQoL (RAND-36)
Time Frame: 8 weeks
spousal caregivers' HRQoL (RAND-36)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Rosario

Investigators

  • Principal Investigator: daniel serrani, Universidad Nacional de Rosario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGIED01
  • ´GIED01 (Registry Identifier: PGIED01)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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