Quality of Life Clinical Trial
Official title:
Temporally-Oriented Subjective Well-being Across Transitions—Resources & Outcomes
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.
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.
;
Observational Model: Cohort
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
| Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
| Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
| Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
| Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
| Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
| Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
| Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
| Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
| Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
| Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
| Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
| Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
| Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
| Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
| Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
| Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
| Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
| Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
| Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A |