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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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:
- describe the person and environment characteristics and activity patterns of residents in long-term care (LTC) facilities;
- modify the evidence-based, occupation-based cultural heritage intervention (OBCHI) grounded on the results of Aim 1;
- test the effectiveness of the OBCHI intended to facilitate adaptation to relocation into LTC facilities relative to a usual activities group;
- determine the cost-effectiveness of the intervention conducted by in-house staff compared to the control group; and
- 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
- Describe the person and environment characteristics and activity patterns of residents in LTC facilities.
- Modify the OBCHI grounded on the evidence-based results of Aim 1 specific to these facilities and residents.
- 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
- 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.
- 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
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: OBCHI |
| Control | No intervention | The 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.
Quality of Life
QOLNH by Ferran
Measured: Change is being assessed at baseline, 1 week and 1 month follow up
Secondary outcomes (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.
- First posted4 Jan 2017 (estimated)
- Study startSep 2014
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FragilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- Retirement Research Foundation
- Responsible party
- Sponsor
- Investigators
- Donna Tilley, PhD, Study director, Texas Woman's University
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Occupation-Based Cultural Heritage Intervention in Long-Term Care Facilities
- ClinicalTrials.gov ID
- NCT03009851
- Acronym / sponsor ID
- OBCHI / RRF 2014-090
- Conditions
- Fragility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- Retirement Research Foundation
- Study start
- Sep 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of the proposed research were to:
- describe the person and environment characteristics and activity patterns of residents in long-term care (LTC) facilities;
- modify the evidence-based, occupation-based cultural heritage intervention (OBCHI) grounded on the results of Aim 1;
- test the effectiveness of the OBCHI intended to facilitate adaptation to relocation into LTC facilities relative to a usual activities group;
- determine the cost-effectiveness of the intervention conducted by in-house staff compared to the control group; and
- examine person and environment factors as potential moderators of the relationship between treatment condition and adaptation outcomes.
Detailed description
Specific Aims
Primary Aims
- Describe the person and environment characteristics and activity patterns of residents in LTC facilities.
- Modify the OBCHI grounded on the evidence-based results of Aim 1 specific to these facilities and residents.
- 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
- 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.
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OBCHI | Experimental | Behavioral: OBCHIThis small group process intervention focuses upon the cultural heritage of the residents in LTC settings measuring quality of life, activity engagement and social participation. |
| Control | No intervention | –The control group only received the typical activities conducted in LTC facilities. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English speaking, less than one year from admission, cognitive level of 4/5 on SPMSQ
Key exclusion criteria (1 listed)
- non English speaking, more than one year in LTC, and less than cut off score on SPMSQ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBCHIAlso: occupation-based cultural heritage interventionOccupation-based cultural heritage intervention emphasizing the cultural background of residents in LTC settings. | Behavioural | OBCHI |
Primary outcome
Quality of Life
Time frame: Change is being assessed at baseline, 1 week and 1 month follow up
QOLNH by Ferran
1 secondary outcome
SF-12
Time frame: Change is being assessed at baseline, 1 week and 1 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Tilley, PhD study director
Texas Woman's University
1 site in 1 country: see every site and its status.
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.