NCT02391766

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 4, 2014

Last Update Submit

March 17, 2015

Conditions

EmpowermentSelf EfficacyQuality of Life

Keywords

Self-managementCaregivingQuality of lifeEmpowerment

Outcome Measures

Primary Outcomes (1)

  • patients' HRQoL (15D)

    patients' HRQoL (15D)

    8 weeks

Secondary Outcomes (3)

  • caregivers' psychological well-being (GHQ-12)

    8 weeks

  • caregivers sense of competence (SCQ).

    8 weeks

  • spousal caregivers' HRQoL (RAND-36)

    8 weeks

Study Arms (2)

empowerment group

ACTIVE COMPARATOR

empowerment intervention by us for us guides

Behavioral: empowerment

no treatment group

PLACEBO COMPARATOR

dementia patients treatment as usual

Behavioral: usual care

Interventions

empowermentBEHAVIORAL

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.

Also known as: by us for us guides
empowerment group
usual careBEHAVIORAL
no treatment group

Eligibility Criteria

Age56 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology

Rosario, Santa Fe Province, 2000, Argentina

Location

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • daniel serrani

    Universidad Nacional de Rosario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

March 18, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

AR(1)