Ignite Creation Date:
2024-05-06 @ 10:04 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03150095
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2017-05-10
Brief Title:
Health Coaching to Improve Self-Management in Thoracic Transplant Candidates
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Health Coaching to Improve Self-Management in Thoracic Transplant Candidates
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ones 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 eg frailty and obesitySelf-management abilities may be improved via behavioral interventions such as health coachingSelf-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 factorsThe 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 andor 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
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 ones 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 eg frailty and obesitySelf-management abilities may be improved via behavioral interventions such as health coachingSelf-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 factorsThe 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 andor 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
Detailed 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 mentors 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 OARS 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 patients 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 PittsburghPA 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 081 using a two-group t-test with a 005 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 8550 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 60 in particular the end of study SD for SMAS-30 would be 60 or less With this SD we would have power to detect a difference of 081x6049 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 005 will be considered statistically significant Post intervention focus groupsinterviews of 5-7 participants will be conducted by the candidate to obtain patient feedback to refine the intervention for future R01
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 mentors 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 OARS 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 patients 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 PittsburghPA 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 081 using a two-group t-test with a 005 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 8550 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 60 in particular the end of study SD for SMAS-30 would be 60 or less With this SD we would have power to detect a difference of 081x6049 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 005 will be considered statistically significant Post intervention focus groupsinterviews of 5-7 participants will be conducted by the candidate to obtain patient feedback to refine the intervention for future R01
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23HL128859 | NIH | None | httpsreporternihgovquickSearchK23HL128859 |