Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03150095 |
| Other study ID # |
17-003921 |
| Secondary ID |
K23HL128859 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 25, 2019 |
| Est. completion date |
November 2, 2021 |
Study information
| Verified date |
November 2022 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Ability to adhere to complex medical regimens is critical to achieving successful transplant
outcomes, as non-adherent patients suffer graft failure and death following transplantation.
Since potential recipients greatly exceed organ availability, identification of candidates
who will adhere to complex post-transplant regimens is critically important and emphasized by
practice guidelines. When selecting candidates for transplant, physicians try to subjectively
predict post-transplant adherence because, although tools exist to measure current adherence,
tools that reliably predict future adherence are lacking. Despite rigorous medical and
psychosocial screening pretransplant, non-adherence rates are high following transplant.
Therefore, the current approach for predicting future non-adherence is suboptimal,
subjective, and greatly needs strategies for improvement.
Pre-transplant self-management abilities represent a marker of future adherence
post-transplant. Assessing self-management as a means for predicting future adherence has
been largely overlooked. Self-management is defined as "taking responsibility for one's own
behavior and well-being" and consists of three management tasks: medical condition, emotions,
and social roles. Self-management ability can be measured. However, self-management has not
been systematically studied in heart and lung transplant patients. Fostering self-management
abilities may improve post-transplant outcomes by optimizing not only adherence, but also
proven pretransplant risk factors (e.g. frailty and obesity).Self-management abilities may be
improved via behavioral interventions such as health coaching.Self-management represents a
measurable criterion that could be utilized in pre-transplant screening and serve as a point
of intervention for optimizing adherence and pre-transplant risk factors.The overall
objective of the proposed research is to improve the knowledge gap regarding self-management
(and thereby adherence) in transplant by qualitatively and quantitatively studying patient
factors associated with self-management and testing an intervention that may improve
self-management.
The investigators hypothesize: Individualized health coaching including strategies to address
poor resilience, coping with uncertainty, frailty, and/or negative affect will be an
effective therapeutic strategy at improving self-management while in the pre-transplant
state.
Specific Aim: To test whether transplant candidates who receive pre transplant health
coaching have greater improvement in self-management abilities.
The investigators will conduct a randomized, controlled pilot trial testing the effectiveness
of health coaching versus usual care in a heart and lung transplant cohort on self-management
abilities (SMAS-30).
Description:
PROPOSED RESEARCH: Patients will be identified from the Mayo Clinic MN, heart and lung
transplant waiting lists and approached for recruitment in the Transplant Clinic at one of
their routine clinical (every 1 to 3 month) follow-up appointments or by phone or mail.
Inclusion criteria: Aged 18 or older, consenting to research, and listed (active and
temporarily inactive) or deferred for lung or heart transplantation at Mayo Clinic in
Rochester, MN. Exclusion criteria: Patients will be excluded if ineligible for transplant,
non-English speaking, non-verbal or extremely hard of hearing.
RESEARCH STRATEGY: This is a single-center, prospective, randomized, controlled, pilot study
comparing the effect of a phone-based, health coaching intervention versus usual care on
self-management. Methods: Initial encounter: Consented patients will be randomized using a
random number generator. Intervention patients will be introduced to the intervention, and
schedule the first phone meeting. Both intervention and control patients will undergo
baseline assessments (see "data" below). Subsequent Coaching Intervention patients will be
assigned a coach trained in motivational interviewing who will call the patient weekly for 12
weeks for a 15-30 minute intervention (based on the primary mentor's previous research).
Briefly a health coaching protocol will be utilized to guide training and the delivery of
intervention using open-ended questions, affirmations, reflections, and summaries (O.A.R.S.)
and Elicit-Provide-Elicit (E-P-E) techniques. Coaching sessions will be recorded and
externally monitored by an independent expert to assure treatment fidelity. A coaching
intervention protocol will include collaborative goal setting and confidence rating regarding
the patient's desired behavior change (and assessed risks). The control group will receive
usual care. Both intervention and control patients will complete follow-up questionnaires and
physiologic assessments at 12-16 weeks. Data: Baseline demographic, comorbidities, and
transplant details will be abstracted. Daily physical activity measure by a gold standard
activity monitor (Sensewear Armband, Body media, Pittsburgh,PA) will quantify daily steps, as
well as total and active energy expenditure. Grip Strength: will be measured using a Jamar
Digital Hand Held Dynamometer. Three serial measurements will be taken (using the dominant
hand), averaged, and adjusted by gender and BMI using normative table. Gait Speed:
self-selected walking speed will be timed over a distance of 15 ft (average of 3 adjusted for
gender and height). Body composition scan: will determine fat-free mass (body composition).
Height and weight will be recorded. Questionnaires: RISC-10, PANAS, MUIS, KCCQ, CRQ, FDI,
CES-D, PHQ-2, GAD-2, SMAS-30, and SMAQ will be collected to assess hypothesized predictors of
self-management. The primary outcome of the study is the effect of health coaching on
self-management abilities SMAS-30 (sentinel of post- transplant adherence).
ANALYSIS PLAN: Sample size: This is a pilot and feasibility study. However, to inform our
enrollment we have made the following calculations. Change in SMAS-30. A sample size of 25 in
each group will have 80% power to detect an effect size of 0.81 using a two-group t-test with
a 0.05 two-sided significance level, where effect size is the end of study difference in
means between the two groups relative to the SD of the end of study measures, after adjusting
for baseline and other factors. From the literature, we estimate an unadjusted end of study
SD for SMAS-30 of 8.5.50 Whereas we do expect our intervention to impact SMAS-30, it is our
clinical impression that without intervention, patients tend to exhibit similar patterns over
time. Therefore, we expect the between-person variability in SMAS-30 to be at least as large
as the variability in assessing SMAS-30 for the same person at different time points. If
these two sources of variability were the same then they would both have a SD of 6.0, in
particular the end of study SD for SMAS-30 would be 6.0 or less. With this SD, we would have
power to detect a difference of 0.81x6.0=4.9. Thus, this pilot study is reasonably powered.
Allowing for a 20% withdrawal rate (primarily due to transplantation during intervention), we
will aim for a sample size of 30 per arm. Analysis plan: Demographic characteristics will be
summarized by mean, median, SD and range (continuous variables) and counts and percents
(categorical variables). Our primary variable will be end of study SMAS-30 (adjusting for
baseline), which we will analyze using analysis of covariance (ANCOVA), estimating between
group differences. Subgroup analysis will be performed by sex, ethnicity, and race as
feasible. A similar procedure to that described above will be employed to impute data if
necessary. Missing data and end of study SDs for SMAS-30, adjusting for baseline, will guide
analysis and power calculations for future R01 studies. Secondary Outcomes will examine
between group differences of changes in gait speed, activity levels, body composition,
weights, and RISC-10, PANAS, MUIS, FDI, SMAQ, and KCCQ or CRQ measures to inform future R01
planning. A two-tailed p< 0.05 will be considered statistically significant. Post
intervention focus groups/interviews of 5-7 participants will be conducted by the candidate
to obtain patient feedback to refine the intervention for future R01.
