NCT03009851

Brief Summary

The goals of the proposed research were to:

  1. 1.describe the person and environment characteristics and activity patterns of residents in long-term care (LTC) facilities;
  2. 2.modify the evidence-based, occupation-based cultural heritage intervention (OBCHI) grounded on the results of Aim 1;
  3. 3.test the effectiveness of the OBCHI intended to facilitate adaptation to relocation into LTC facilities relative to a usual activities group;
  4. 4.determine the cost-effectiveness of the intervention conducted by in-house staff compared to the control group; and
  5. 5.examine person and environment factors as potential moderators of the relationship between treatment condition and adaptation outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

December 21, 2016

Last Update Submit

January 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    QOLNH by Ferran

    Change is being assessed at baseline, 1 week and 1 month follow up

Secondary Outcomes (1)

  • SF-12

    Change is being assessed at baseline, 1 week and 1 month follow up

Study Arms (2)

OBCHI

EXPERIMENTAL

This small group process intervention focuses upon the cultural heritage of the residents in LTC settings measuring quality of life, activity engagement and social participation.

Behavioral: OBCHI

Control

NO INTERVENTION

The control group only received the typical activities conducted in LTC facilities.

Interventions

OBCHIBEHAVIORAL

Occupation-based cultural heritage intervention emphasizing the cultural background of residents in LTC settings.

Also known as: occupation-based cultural heritage intervention
OBCHI

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking, less than one year from admission, cognitive level of 4/5 on SPMSQ

You may not qualify if:

  • non English speaking, more than one year in LTC, and less than cut off score on SPMSQ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Houston, Texas, 77030, United States

Location

Study Officials

  • Donna Tilley, PhD

    Texas Woman's University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 4, 2017

Study Start

September 1, 2014

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Data will be presented without names and by treatment and/or control group. Information may include: gender, age, ethnicity, education level, and/or scores from the outcome measures. This information will be shared via publications and professional presentations. The IRB is currently approved and continues to be renewed on a yearly basis. Contact the PI for further information.

Locations