NCT00632684

Brief Summary

This study will develop and evaluate the effectiveness of an adaptive treatment model for reducing the stress of, and burden on, family members caring for a person with dementia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

November 23, 2011

Status Verified

April 1, 2009

Enrollment Period

2.6 years

First QC Date

March 7, 2008

Last Update Submit

November 22, 2011

Conditions

Keywords

Family CaregivingDementia

Outcome Measures

Primary Outcomes (1)

  • Role overload

    Measured immediately after treatment

Secondary Outcomes (1)

  • Nine-Item Depression Scale of the Patient Health Questionnaire (PHQ-9)

    Measured immediately after treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Participants in Phase 1 will undergo four interviews, including a single treatment planning session.

Behavioral: Interviews with a single treatment planning session

2

EXPERIMENTAL

Participants in Phase 2 will receive the adaptive treatment model.

Behavioral: Adaptive treatment model

Interventions

Participants in Phase 1 will attend four 90-minute interviews over 4 months. During interviews, participants will be asked about their experiences caring for their relatives, physical and emotional well-being, and ideas on helpful types of assistance. Participants will also receive information about programs and services that may help them carry out caregiving activities.

1

The adaptive treatment model will include up to ten 60- to 75-minute planning sessions. The sessions will focus on psychosocial issues and will be tailored to participants' specific risk factors.

2

Eligibility Criteria

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

You may qualify if:

  • Primary caregiver of a person suffering from any type of dementia and living in the community

You may not qualify if:

  • Primary caregiver of person with late- or end-of-life stage dementia
  • Primary caregiver of person with dementia who lives in skilled nursing care environment
  • Primary caregiver is under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benjamin Rose Institute

Cleveland, Ohio, 44120, United States

Location

MeSH Terms

Conditions

Dementia

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Steven H. Zarit, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR
  • Carol J. Whitlatch, PhD

    Benjamin Rose Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 11, 2008

Study Start

July 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

November 23, 2011

Record last verified: 2009-04

Locations