Testing the Effectiveness of an Occupation-based Cultural Intervention in Long-term Care

Fragility Clinical Trial

— OBCHI  

Official title:

Testing an Occupation-Based Cultural Heritage Intervention in Long-Term Care Facilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009851
• Other study ID #: RRF 2014-090
• Status: Completed
• Phase: N/A
• First received: December 21, 2016
• Last updated: January 2, 2017
• Start date: September 2014
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The goals of the proposed research were to:

1. describe the person and environment characteristics and activity patterns of residents in long-term care (LTC) facilities;

2. modify the evidence-based, occupation-based cultural heritage intervention (OBCHI) grounded on the results of Aim 1;

3. test the effectiveness of the OBCHI intended to facilitate adaptation to relocation into LTC facilities relative to a usual activities group;

4. determine the cost-effectiveness of the intervention conducted by in-house staff compared to the control group; and

5. examine person and environment factors as potential moderators of the relationship between treatment condition and adaptation outcomes.

Description:

Specific Aims

Primary Aims

1. Describe the person and environment characteristics and activity patterns of residents in LTC facilities.

2. Modify the OBCHI grounded on the evidence-based results of Aim 1 specific to these facilities and residents.

3. Test the effectiveness of the OBCHI conducted by activity department staff, relative to usual activities, as measured by quality of life, activity engagement, and social participation.

H1a-c: Those receiving OBCHI will have significantly greater improvement in

a) quality of life, b) activity engagement, and c) social participation at post-intervention relative to those receiving usual activities.

H2a-c: Those receiving OBCHI will have greater maintenance of improvements in a) quality of life, b) activity engagement, and c) social participation at 1-month follow-up, relative to those receiving usual activities.

4. Determine the cost-effectiveness of the intervention in terms of quality adjusted life year (QALY) and other health factors.

H3: When OBCHI is proven to be more effective in promoting quality of life than usual activities, the investigators will expect the OBCHI to produce a higher QALY at a lower cost per QALY.

H4: Between these two mutually exclusive treatments, the OBCHI intervention will be more efficient (more effective and less costly) or cost saving with a negative incremental cost-effectiveness ratio (ICER) when compared to those receiving usual activities.

Exploratory Aim

5. Examine person characteristics (i.e. cultural heritage, life experiences social support, resilience, depression, and resident demographics [age, gender, ethnicity]) and select environment characteristics (i.e., participant perceptions of the intervention and facility) as potential moderators of the relationship between treatment condition (OBCHI versus usual care) and change in adaptation outcomes from pre- to post-intervention.

Table 1. Timeline of Person/Environment Factors, Outcomes and Tools

Person Characteristics Tools Baseline 1 wk. post 1 m. follow-up

Cognitive Screen SPMSQ x

Life Experience Interview x

Social Support Yesterday Interview x x x

Resilience Resilience Scale x

Depression GDS-15 x x x

Environment Characteristics

LTC Facility Setting Site Demographics x

Resident Perceptions SCES x x x Intervention Evaluation (midway) x

Staff Perceptions Questionnaire x x

Outcomes

QoL QOLI/SF-12 x x x

Cost Effectiveness SF-12 x x x

Activity Engagement and Social Participation Yesterday Interview x x x

Significance

As the need for LTC increases with the steady growth of older adults, relocation into residential settings will grow. About 70 percent of persons over 65 will require spending time in LTC services, with 40 percent requiring nursing home care for a period of time. Relocation is moving from one permanent home to another permanent home which is sometimes precipitated by an illness and considered a significant life event. Skinner noted a forced relocation could have disturbing effects upon the elderly including loss of social and community connections. However, even with a planned relocation, encountering this new and unfamiliar environment requires the older person to rethink the ways in which his or her life will differ with adjustment duration of a few weeks to several years. Many factors determine the ways in which this 'new life' will evolve including: past adaptive strategies and life experiences, family support systems, socioeconomic resources, and cultural values.

Moving from a familiar environment to an unfamiliar one involves adaptation, regardless of age. Adaptation is a process involving interaction between the person and environment. Indicators of successful adaptation to LTC have included: developing a sense of identity and place, having care needs met, knowing and being known to other residents, maintaining or developing social networks, continuity of lifestyle, and maintaining control over life situations. As defined for this study, adaptation is a normal process by which a person encounters a perceived challenge in the environment and is able to successfully manage that challenge as measured by increased quality of life, activity engagement and social participation. Central to adaptation is the cultural heritage that an individual brings to the LTC facility upon relocation. Because culture is the learned beliefs, values, customs, actions, communication, and life ways of an individual, it can be expected to permeate all aspects of life in a residential facility. Attention to an individual's cultural heritage has begun to make in-roads to the daily life routines encountered in these facilities.

Acknowledgement of the resident's culture is a major contributing factor to his/her quality of life (QOL). However, QOL is a complex construct and has been used synonymously with terms like well-being, life satisfaction, and functional health. Lawton asserted that QOL is a collection of dimensions comprised of both objective and subjective factors which may include all or some of the following: behavioral competence, objective environment, perceived QOL, psychological well-being, and health-related status. Other factors associated with QOL include: interaction with family and friends, personal qualities, room and meal items, number of health problems, staff-resident ratios and continuity of care. These findings attest to the importance of a person-environment 'match' when QOL issues for residents are considered.

Incorporating meaningful activity and social connections into the lives of elders that have been circumscribed by illness and disability is particularly important to QOL. Gerontological literature concerning the activities of elders has concentrated upon personal care and instrumental activities and how they contribute to health and functional status. These obligatory tasks are essential to one's survival, but perhaps even more significant to an elder's well-being are those discretionary activities involving social and meaningful occupations; such findings support the proposition that activity and social support systems are important in mediating the impact of illness on well-being.

In summary, the relationship of relocation, culture, adaptation, QOL, activity engagement, and social participation is reflected in outcomes where failure to provide culturally competent and culturally sensitive care have occurred. With increasing diversity of the US population, practitioners are challenged to deliver culturally competent services and to improve the QOL for diverse LTC residents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fragility

Intervention

Behavioral:
• OBCHI
Occupation-based cultural heritage intervention emphasizing the cultural background of residents in LTC settings.

Locations

Country	Name	City	State
United States	Texas Woman's University	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Woman's University	Retirement Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	QOLNH by Ferran	Change is being assessed at baseline, 1 week and 1 month follow up	No
Secondary	SF-12	Measurement of general health	Change is being assessed at baseline, 1 week and 1 month follow up	No