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FragilityOBCHINCT03009851

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

A study testing OBCHI in people with Fragility, run by Texas Woman's University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Fragility
What is being tested?
OBCHI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Sep 2014to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Woman's University

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.
Read the detailed 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
  4. 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.
  5. 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
  6. 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.

Conditions
Fragility
Being tested
OBCHI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OBCHIBehavioural

    Also called occupation-based cultural heritage intervention

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

Study groups in NCT03009851
Study groupRoleWhat they receive
OBCHIExperimentalThis small group process intervention focuses upon the cultural heritage of the residents in LTC settings measuring quality of life, activity engagement and social participation.
Receives: Behavioral: OBCHI
ControlNo interventionThe control group only received the typical activities conducted in LTC facilities.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life

    QOLNH by Ferran

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

Secondary outcomes (1)
  1. SF-12

    Measurement of general health

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2017 (estimated)
  2. Study startSep 2014
  3. Primary completionFeb 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03009851
Sponsor's protocol ID
RRF 2014-090
Acronym
OBCHI
Status last verified
Jan 2017
First submitted
21 Dec 2016
Last updated
4 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing OBCHI in people with Fragility, run by Texas Woman's University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (time frame: Change is being assessed at baseline, 1 week and 1 month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.

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