"Living Together With Dementia"_Creation and Validation o... | NCT03015428

Studies
"Living Together With Dementia"_Creation and Validation of a Training Program for Family Caregivers of People With Dementia to Live at Home

NCT03015428

Sponsor

Centro Hospitalar De São João, E.P.E.

Status

Completed

Last Update Posted

Jan 10, 2017Estimated

Enrollment

25Actual

Phase

Not Applicable

Conditions

Dementia

Interventions

psychoeducation

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Apr 10, 2016

First Submission Date that Met QC Criteria

Jan 7, 2017

First Posted Date

Jan 10, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2017

Last Update Posted Date

Jan 10, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lia Sousa, Principal Investigator, Centro Hospitalar De São João, E.P.E.Principal Investigator

Lead Sponsor

Centro Hospitalar De São João, E.P.E.OTHER

Collaborators

Not provided

Description Module

Brief Summary

This study aims to experimentally evaluate the training program for family caregivers of people with dementia_"Living together with Dementia."

Detailed Description

This study will begin in March 2016, with the initial assessment of family caregivers of people with dementia.

These were recruited through hospital neurology clinic and must comply with a set of pre-established criteria.

It is expected a total of 20 participants in the study (10 in the experimental group and 10 in control group).

Interventions will take place over the months of March and April. The final evaluation is scheduled for late April and the follow up to July 2016.

an evaluation document itself for this study was built.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psychoeducation	Experimental	Interventions: Give information Teach and train strategies	Other: psychoeducation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
psychoeducation	Other	Providing knowledge and skills development in family caregivers of people with dementia, through a structured psychoeducational programme	Psychoeducation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Caregiver Overload Scale		7 weeks
Carers Assessment Satisfaction Index		7 weeks
Carers Assessment Difficulties Index		7 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be primary caregiver of the person with dementia
Be able to read and write
Carers of peolpe with dementia in initial or moderate stage

Exclusion Criteria:

The person with dementia have severe mental pathologies associated

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lia Sousa, Master	Centro Hospitalar De São João, E.P.E.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHSaoJoao		Porto			Portugal

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided