NCT01652222

Brief Summary

The purpose of the study is to assess the efficacy of the systematic application of the CONEM-BETA game in the subjective welfare of family caregivers of patients with Alzheimer's disease or other advanced stage dementia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

July 25, 2012

Last Update Submit

July 8, 2014

Conditions

Alzheimer's DiseaseDementia

Keywords

Alzheimercaregiverdementiasocial supportMontessoriTherapeutic game

Outcome Measures

Primary Outcomes (1)

  • change from baseline compared to the control and active arms using the EBP questionnaire (subjective welfare of family caregivers of patients with possible or probable Alzheimer or other advanced stage dementia)

    The EBP (Escala de Bienestar Psicologico - Psychological Welfare Scale) assesses the degree of the person self-satisfaction, comfort with himself during a period of his life, and contains four sub-scales: subjective welfare, material welfare, professional welfare and welfare of the relationship with his partner. It allows also to obtain partial scores, that allow to have indicators of overall welfare psychological index, and a weighted score obtained from the items with higher discriminative power

    8 weeks

Secondary Outcomes (5)

  • change from baseline compared to the control and active arms using the Cornell scale and NPI-Q to assess behaviour of the patients with probable or possible Alzheimer's disease or other advanced stage dementia

    8 weeks

  • change from baseline compared to the control and active arms using the Martin and cols. scale to assess the overload level of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia

    8 weeks

  • change from baseline compared to the control and active arms using the Goldberg's scale to assess anxiety and depression of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia

    8 weeks

  • change from baseline compared to the control and active arms using the DUKE-UNC scale to assess the perceived social support of the family caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia

    8 weeks

  • change from baseline compared to the control and active arms using the PANAS scale to assess the changes in positive and negative affect of the caregivers of patients with probable or possible Alzheimer's disease or other advanced stage dementia

    8 weeks

Study Arms (3)

CONEM-BETA + socio-educational training

EXPERIMENTAL

Caregivers will receive 4 socioeducational training sessions during an 8 week period. These sessions will focus on the description and process of the Alzheimer's disease (AD), and will also provide to the caregivers resources and strategies to cope with AD. During the last 4 weeks, they will also systematically play with the patient at home with the CONEM-BETA game. After that period, caregivers will use the game based on their preference and frequence during a period of 6 more weeks.

Other: CONEM-BETA + socio-educational training

Socio-educational training only

ACTIVE COMPARATOR

Caregivers will receive the same 4 socioeducational training sessions as the experimental group, during an 8 week period.

Other: Socio-educational training only

Control

NO INTERVENTION

Caregivers of this group will behave with his/her patient during the trial as they have been doing so far, but will receive no intervention

Interventions

CONEM-BETA + socio-educational trainingOTHER

4 socio-educative training sessions during 8 weeks, and caregivers will systematically play with their patients with CONEM-BETA therapeutic game during the last 4 weeks. The dyads will be assessed (primary timepoint). Caregivers will then continue using the game with their patients for an extra 6 weeks period as needed, to assess adherence and games preferences.

CONEM-BETA + socio-educational training
Socio-educational training onlyOTHER

4 socio-educative training sessions during 8 weeks

Socio-educational training only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to be a family caregiver of an person diagnosed with possible or probable Alzheimer's disease or other advanced stage dementia
  • show interest in participating
  • Sign informed consent
  • to have a probable or possible Alzheimer type dementia or other advanced dementia according to a diagnosis done by a Specialized Evaluation Unit
  • GDS 5-6 and a minimental equal or lower than 12.
  • to preserve a verbal comprehension of basic instructions
  • to preserve the mobility of the arms, as well as the visual and auditive capacities that allow to conduct the activities.

You may not qualify if:

  • to have a negative attitude towards the emotional interaction with his/her Alzheimer or dementia family member
  • Unavailability
  • to participate in other socio-educative interventions during the study period.
  • Any other situation that makes the caregiver as not suitable according to investigator's criteria
  • Do not have the sensorial or motor capacities needed for the interaction.
  • Serious impairment of the verbal comprehension
  • Disabling health conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital de Santa Maria

Lleida, Catalonia, Spain

Location

Hospital de Salt

Salt, Catalonia, Spain

Location

Hospital Universitari Mutua de Terrassa

Terrassa, Catalonia, Spain

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Iciar Ancizu, PhD

    SARquavitae, Barcelona, Spain

    PRINCIPAL INVESTIGATOR

  • Sandra Poudevida, PhD

    Pasqual Maragall Foundation, Barcelona, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 27, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

ES(3)