Quality of LifeLIFTNCT01583946
Temporally-Oriented Subjective Well-being Across Transitions-Resources & Outcomes
An observational study of Quality of Life, run by University of Pittsburgh at 1 site in United States.
Trial summary
As individuals age, they undergo transitions in many aspects of their lives. These transitions include social, economic and health transitions. People review their lives, and reflect on past choices. Future time is limited by the increasing proximity to end of life. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- How many people
- 793 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to May 2016
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and females 50 and older
Who may be able to join
- participants will be included if they are GIMO patients who complete the FAST,
- are aged 50 or older,
- agree to participate, and
- belong to an unfilled bin.
Who cannot join
- Investigators will exclude individuals from the purposive sample who do not provide informed consent. There will be no exclusion based on race, gender, immigration, or HIV status.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of General Internal Medicine UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
About this study
As individuals age, they undergo transitions in many aspects of their lives. These transitions include social, economic and health transitions. People review their lives, and reflect on past choices. Future time is limited by the increasing proximity to end of life. This may lead to regrets and, in people with the ability to use compensatory mechanisms, a redoubling of efforts to achieve valued goals or a reprioritization of valued goals. In the context of aging, individuals' past, present, and future-oriented subjective well-being (SWB) may change. There is an incomplete understanding of the relationship of SWB, intra- and inter-personal resources, and outcomes, (particularly health and healthcare-cost outcomes). These issues have complicated the use of SWB measures and the investigators are left with traditional metrics such as life expectancy, infant mortality, wealth, and poverty to assess healthy aging, resulting in an incomplete picture of healthy aging. This project will examine the relationships among SWB, intra- and inter-personal resources, and health and healthcare-cost outcomes. It will advance the understanding of SWB and its role in healthy aging in order to assist policy makers in valuing the potential benefits of improving SWB on health and healthcare costs. The investigators will accomplish this through the following specific aim:
Aim 1: To determine how SWB (past, present, and future-oriented): (1) is affected by life transitions, and (2) affects outcomes after life transitions.
Read the detailed description
Aim: To determine how Subjective Well-Being (SWB; past, present, and future-oriented): (1) is affected by life transitions, and (2) affects outcomes after life transitions.
Rationale: Social, economic, and health transitions are common in aging populations. Adaptation to these transitions likely impacts SWB and therefore may alter subsequent health and healthcare-cost outcomes.
Hypotheses: Negative life transitions will negatively impact assessments of present and future-oriented SWB and result in worse health and healthcare-cost outcomes. More positive intra- and inter-personal resources will lessen this impact. Having better present or future-oriented SWB will diminish the impact of the transition on health and healthcare-cost outcomes.
Approach: Investigators will establish an observational cohort of adults aged 50 and older (n=600) seen in the same primary care practice stratified by gender, race, and SWB. Investigators will collect information at baseline and each of two annual follow-up assessments regarding SWB, intra- and inter-personal resources, and outcomes. Investigators will compare those who experience life transitions to those who do not in terms of their changes in the temporal perspectives of SWB, health, and healthcare-cost outcomes.
The successful completion of this project will disentangle temporal perspectives in SWB, further the understanding of the impact of aging and life transitions on SWB, relate individuals' SWB to health and healthcare-cost outcomes, and clarify the relationship of experienced SWB to evaluative SWB, all within the context of intra- and inter-personal resources. It will enable researchers, clinicians, and policy makers to better use SWB as a metric assessing the health and welfare of individuals and societies. The study population is primarily older adults from a primary care practice, University of Pittsburgh's General Internal Medicine Oakland (GIMO).
Aim: To determine how SWB (past, present, and future-oriented): 1) is affected by life transitions and 2) affects outcomes after life transitions.
C.2.a. Overview of the Aim Social, economic, and health transitions, commonly occur in aging populations. Adaptation to these transitions likely impacts SWB and subsequent health and healthcare-cost outcomes.
Investigators will enroll a purposive sample (n=600) of adults aged 50 and older seen at the GIMO primary care practice. Investigators will collect information at baseline and each of two annual follow-up assessments regarding SWB, intra- and inter-personal resources and outcomes. Investigators will compare those who experience life transitions to those who do not in terms of their changes in temporally-oriented SWB and health and healthcare-cost outcomes.
Measures In addition to basic demographics including age, gender, ethnicity, race, educational attainment, marital status, and employment status, investigators will collect data described below.
Subjective Well-Being. Investigators will use the temporal measure of SWB by Pavot, Deiner, and Suh8 which includes 15 items-5 representing each of past, present, and future-oriented SWB.
Intra- and inter-personal resources. These constructs were selected because they are important to the understanding of SWB and the relationships between SWB and the outcomes tested in our model. Each instrument has been related to health outcomes, healthcare-cost outcomes, SWB, and/or health-related quality of life in prior work and key citations are provided. Bringing together such a comprehensive assessment battery to understand temporally-oriented SWB and its relationship to these measures and outcomes, the impact of transitions on these relationships, and the relationship of experiences and experienced SWB to evaluative SWB, as proposed in the current project, is necessary to advance the field.
Definition of transitions. Separate groups will be defined for those who undergo, or do not undergo, three broad categories of transitions: social, economic, and health, or any of the three transitions; individuals may have more than one type transition. In addition to "any" transition, each transition type will be analyzed separately. As described in the significance section, investigators have found that these transitions are common in older adults. Participants will complete items from the Life Events Scale at each time-point. Investigators will use MARS and EpicCare to identify any new health conditions (based on additions to the problem list or past medical history) supplement the identification of health transitions.
Health and healthcare costs. Investigators will use health and healthcare costs to assess the predictive validity of our measure in the Primary care sample. Health and healthcare-cost measures will be obtained from both the using the Medical Archival System (MARS)43 and the EpicCare electronic medical record (EMR). MARS data include all patients seen at the University of Pittsburgh Medical Center's (UPMC) twenty hospitals, four long-term care facilities, and 350 physician offices and outpatient clinics. The MARS repository houses 209 million clinical reports, 460 million financial transactions, and patient demographic information. EpicCare, GIMO's EMR, electronically contains all information required in a traditional paper medical record. All documentation (including past medical history), orders, and results are captured. Any paper result, for example laboratory testing done out of state, is abstracted as discrete data items into EpicCare. The primary measure will be healthcare costs. Cost outcomes, from MARS and EpicCare, will include the total healthcare charges documented within the UPMC system (including outpatient prescription medications at the average retail cost) in the year following the assessment. As the largest provider of care in Western Pennsylvania, UPMC delivers the vast majority of care received by GIMO patients.
Why use costs as the primary measure in this sample? Healthcare costs provide a relatively simple summary of overall care intensity across people with a variety of health concerns and is particularly relevant to health policy. It is broadly applicable and is responsive to this request for applications. Two alternative endpoints are diagnosis of a new medical condition or disease management process measures. Based on our prior experience, we expect the majority of participants to develop new medical conditions, so treating a new diagnosis as the primary measure would give minimal variation in the measure and would limit our ability to see a difference based on temporally associated SWB. GIMO's clinical variety makes disease management process measures an impractical primary measure. Investigators have chosen to examine two common primary care conditions, diabetes and coronary artery disease, that require both patient and physician participation in management as a secondary measure.
Secondary health measures will include (1) number of new diagnoses developed, (2) hospitalization (yes or no) and, among those hospitalized, length of stay, and (3) disease management over one year. Investigators will track the development of the following conditions identified by Verbrugge and Patrick: arthritis, visual impairment, hearing impairment, ischemic heart disease, hypertension, chronic obstructive pulmonary disease, diabetes mellitus, and malignant neoplasm.42 A diagnosis will be considered new if it is used as a billing diagnosis and has not been used previously as a billing diagnosis or listed on the problem list or past medical history. Because all participants will have been seen in the past at GIMO we will be able to easily differentiate new from previously existing diagnoses. Hospitalization will be defined as admission to one of twenty UPMC medical or psychiatric hospitals and length of stay. Disease management will be based on percent of fulfilled quality metrics (total number of metrics fulfilled, divided by the total number of metrics) defined by NCQA44 and used as quality measures in GIMO.
- Conditions
- Quality of Life
- Keywords
- subjective well-being, life transitions, health-related quality of life, health, healthcare costs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Male low past-oriented SWB | Not described | |
| Male high past-oriented SWB | Not described | |
| Female low past-oriented SWB | Not described | |
| Female high past-oriented SWB | Not described | |
| Black Female high past-oriented SWB | Not described | |
| Black Female low past-oriented SWB | Not described | |
| Black male low past-oriented SWB | Not described | |
| Black male high past-oriented SWB | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
healthcare costs
healthcare costs
Measured: Over at least 3 years
Secondary outcomes (4)
number of new diagnoses developed
Measured: Over at least 3 years
hospitalization
hospitalization (yes or no)
Measured: Over at least 3 years
hospital length of stay
among those hospitalized, length of stay
Measured: Over at least 3 years
disease management over one year
Measured: Over at least 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Rachel Hess, University of Pittsburgh
- Investigators
- Rachel Hess, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583946
- Sponsor's protocol ID
- PRO11070243
- Other IDs
- 1R01AT007262-01
- Acronym
- LIFT
- Status last verified
- Dec 2015
- First submitted
- 17 Apr 2012
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporally-Oriented Subjective Well-being Across Transitions-Resources & Outcomes
- ClinicalTrials.gov ID
- NCT01583946
- Acronym / sponsor ID
- LIFT / PRO11070243
- Conditions
- Quality of Life
- Keywords
- subjective well-being, life transitions, health-related quality of life, health, healthcare costs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Apr 2012 (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.
As individuals age, they undergo transitions in many aspects of their lives. These transitions include social, economic and health transitions. People review their lives, and reflect on past choices. Future time is limited by the increasing proximity to end of life. This may lead to regrets and, in people with the ability to use compensatory mechanisms, a redoubling of efforts to achieve valued goals or a reprioritization of valued goals. In the context of aging, individuals' past, present, and future-oriented subjective well-being (SWB) may change. There is an incomplete understanding of the relationship of SWB, intra- and inter-personal resources, and outcomes, (particularly health and healthcare-cost outcomes). These issues have complicated the use of SWB measures and the investigators are left with traditional metrics such as life expectancy, infant mortality, wealth, and poverty to assess healthy aging, resulting in an incomplete picture of healthy aging. This project will examine the relationships among SWB, intra- and inter-personal resources, and health and healthcare-cost outcomes. It will advance the understanding of SWB and its role in healthy aging in order to assist policy makers in valuing the potential benefits of improving SWB on health and healthcare costs. The investigators will accomplish this through the following specific aim:
Aim 1: To determine how SWB (past, present, and future-oriented): (1) is affected by life transitions, and (2) affects outcomes after life transitions.
Detailed description
Aim: To determine how Subjective Well-Being (SWB; past, present, and future-oriented): (1) is affected by life transitions, and (2) affects outcomes after life transitions.
Rationale: Social, economic, and health transitions are common in aging populations. Adaptation to these transitions likely impacts SWB and therefore may alter subsequent health and healthcare-cost outcomes.
Hypotheses: Negative life transitions will negatively impact assessments of present and future-oriented SWB and result in worse health and healthcare-cost outcomes. More positive intra- and inter-personal resources will lessen this impact. Having better present or future-oriented SWB will diminish the impact of the transition on health and healthcare-cost outcomes.
Approach: Investigators will establish an observational cohort of adults aged 50 and older (n=600) seen in the same primary care practice stratified by gender, race, and SWB. Investigators will collect information at baseline and each of two annual follow-up assessments regarding SWB, intra- and inter-personal resources, and outcomes. Investigators will compare those who experience life transitions to those who do not in terms of their changes in the temporal perspectives of SWB, health, and healthcare-cost outcomes.
The successful completion of this project will disentangle temporal perspectives in SWB, further the understanding of the impact of aging and life transitions on SWB, relate individuals' SWB to health and healthcare-cost outcomes, and clarify the relationship of experienced SWB to evaluative SWB, all within the context of intra- and inter-personal resources. It will enable researchers, clinicians, and policy makers to better use SWB as a metric assessing the health and welfare of individuals and societies. The study population is primarily older adults from a primary care practice, University of Pittsburgh's General Internal Medicine Oakland (GIMO).
Aim: To determine how SWB (past, present, and future-oriented): 1) is affected by life transitions and 2) affects outcomes after life transitions.
C.2.a. Overview of the Aim Social, economic, and health transitions, commonly occur in aging populations. Adaptation to these transitions likely impacts SWB and subsequent health and healthcare-cost outcomes.
Investigators will enroll a purposive sample (n=600) of adults aged 50 and older seen at the GIMO primary care practice. Investigators will collect information at baseline and each of two annual follow-up assessments regarding SWB, intra- and inter-personal resources and outcomes. Investigators will compare those who experience life transitions to those who do not in terms of their changes in temporally-oriented SWB and health and healthcare-cost outcomes.
Measures In addition to basic demographics including age, gender, ethnicity, race, educational attainment, marital status, and employment status, investigators will collect data described below.
Subjective Well-Being. Investigators will use the temporal measure of SWB by Pavot, Deiner, and Suh8 which includes 15 items-5 representing each of past, present, and future-oriented SWB.
Intra- and inter-personal resources. These constructs were selected because they are important to the understanding of SWB and the relationships between SWB and the outcomes tested in our model. Each instrument has been related to health outcomes, healthcare-cost outcomes, SWB, and/or health-related quality of life in prior work and key citations are provided. Bringing together such a comprehensive assessment battery to understand temporally-oriented SWB and its relationship to these measures and outcomes, the impact of transitions on these relationships, and the relationship of experiences and experienced SWB to evaluative SWB, as proposed in the current project, is necessary to advance the field.
Definition of transitions. Separate groups will be defined for those who undergo, or do not undergo, three broad categories of transitions: social, economic, and health, or any of the three transitions; individuals may have more than one type transition. In addition to "any" transition, each transition type will be analyzed separately. As described in the significance section, investigators have found that these transitions are common in older adults. Participants will complete items from the Life Events Scale at each time-point. Investigators will use MARS and EpicCare to identify any new health conditions (based on additions to the problem list or past medical history) supplement the identification of health transitions.
Health and healthcare costs. Investigators will use health and healthcare costs to assess the predictive validity of our measure in the Primary care sample. Health and healthcare-cost measures will be obtained from both the using the Medical Archival System (MARS)43 and the EpicCare electronic medical record (EMR). MARS data include all patients seen at the University of Pittsburgh Medical Center's (UPMC) twenty hospitals, four long-term care facilities, and 350 physician offices and outpatient clinics. The MARS repository houses 209 million clinical reports, 460 million financial transactions, and patient demographic information. EpicCare, GIMO's EMR, electronically contains all information required in a traditional paper medical record. All documentation (including past medical history), orders, and results are captured. Any paper result, for example laboratory testing done out of state, is abstracted as discrete data items into EpicCare. The primary measure will be healthcare costs. Cost outcomes, from MARS and EpicCare, will include the total healthcare charges documented within the UPMC system (including outpatient prescription medications at the average retail cost) in the year following the assessment. As the largest provider of care in Western Pennsylvania, UPMC delivers the vast majority of care received by GIMO patients.
Why use costs as the primary measure in this sample? Healthcare costs provide a relatively simple summary of overall care intensity across people with a variety of health concerns and is particularly relevant to health policy. It is broadly applicable and is responsive to this request for applications. Two alternative endpoints are diagnosis of a new medical condition or disease management process measures. Based on our prior experience, we expect the majority of participants to develop new medical conditions, so treating a new diagnosis as the primary measure would give minimal variation in the measure and would limit our ability to see a difference based on temporally associated SWB. GIMO's clinical variety makes disease management process measures an impractical primary measure. Investigators have chosen to examine two common primary care conditions, diabetes and coronary artery disease, that require both patient and physician participation in management as a secondary measure.
Secondary health measures will include (1) number of new diagnoses developed, (2) hospitalization (yes or no) and, among those hospitalized, length of stay, and (3) disease management over one year. Investigators will track the development of the following conditions identified by Verbrugge and Patrick: arthritis, visual impairment, hearing impairment, ischemic heart disease, hypertension, chronic obstructive pulmonary disease, diabetes mellitus, and malignant neoplasm.42 A diagnosis will be considered new if it is used as a billing diagnosis and has not been used previously as a billing diagnosis or listed on the problem list or past medical history. Because all participants will have been seen in the past at GIMO we will be able to easily differentiate new from previously existing diagnoses. Hospitalization will be defined as admission to one of twenty UPMC medical or psychiatric hospitals and length of stay. Disease management will be based on percent of fulfilled quality metrics (total number of metrics fulfilled, divided by the total number of metrics) defined by NCQA44 and used as quality measures in GIMO.
Study design
- Observational model
- Cohort
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Male low past-oriented SWB | – | – |
| Male high past-oriented SWB | – | – |
| Female low past-oriented SWB | – | – |
| Female high past-oriented SWB | – | – |
| Black Female high past-oriented SWB | – | – |
| Black Female low past-oriented SWB | – | – |
| Black male low past-oriented SWB | – | – |
| Black male high past-oriented SWB | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females 50 and older
Key inclusion criteria (4 listed)
- participants will be included if they are GIMO patients who complete the FAST,
- are aged 50 or older,
- agree to participate, and
- belong to an unfilled bin.
Key exclusion criteria (1 listed)
- Investigators will exclude individuals from the purposive sample who do not provide informed consent. There will be no exclusion based on race, gender, immigration, or HIV status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
healthcare costs
Time frame: Over at least 3 years
healthcare costs
4 secondary outcomes
number of new diagnoses developed
Time frame: Over at least 3 years
hospitalization
Time frame: Over at least 3 years
hospital length of stay
Time frame: Over at least 3 years
disease management over one year
Time frame: Over at least 3 years
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 9 Jun 2016.
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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.
Rachel Hess, MD, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by University of Pittsburgh 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 4 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 9 Jun 2016. 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?
healthcare costs (time frame: Over at least 3 years). 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 9 Jun 2016.