Trial Outcomes & Findings for Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation (NCT NCT04269239)
NCT ID: NCT04269239
Last Updated: 2026-09-01
Results Overview
ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
COMPLETED
NA
73 participants
Change Score from Baseline to 6-month Follow-Up Period
2026-09-01
Participant Flow
3 Recruitment Hospitals: 1. Kelsey Seybold Clinic 2. Baylor College of Medicine 3. University of Texas Medical Branch
Prior to randomization two assessment visits occurred: 1. Pre-Surgery 2. Post-Surgery Following total hip or knee joint arthroplasty, participants were randomized to one of two study intervention arms. A total of 73 participants provided informed consent and were enrolled. Three participants did not proceed to randomization: one whose scheduled surgery was canceled following an abnormal pre-operative evaluation and who elected not to continue; one who withdrew shortly after consent after learn
Participant milestones
| Measure |
Sleep Habits
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
|
Healthy Habits
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
Reasons for withdrawal
| Measure |
Sleep Habits
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
|
Healthy Habits
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
13
|
Baseline Characteristics
Data were not reported for 1 participant in the Sleep Habits arm, who did not complete the sex/gender item on the study demographic survey.
Baseline characteristics by cohort
| Measure |
Sleep Habits
n=35 Participants
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
|
Healthy Habits
n=35 Participants
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.79 Years
STANDARD_DEVIATION 8.39 • n=35 Participants
|
65.94 Years
STANDARD_DEVIATION 7.36 • n=35 Participants
|
67.39 Years
STANDARD_DEVIATION 7.66 • n=70 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=34 Participants • Data were not reported for 1 participant in the Sleep Habits arm, who did not complete the sex/gender item on the study demographic survey.
|
24 Participants
n=35 Participants • Data were not reported for 1 participant in the Sleep Habits arm, who did not complete the sex/gender item on the study demographic survey.
|
47 Participants
n=69 Participants • Data were not reported for 1 participant in the Sleep Habits arm, who did not complete the sex/gender item on the study demographic survey.
|
|
Sex: Female, Male
Male
|
11 Participants
n=34 Participants • Data were not reported for 1 participant in the Sleep Habits arm, who did not complete the sex/gender item on the study demographic survey.
|
11 Participants
n=35 Participants • Data were not reported for 1 participant in the Sleep Habits arm, who did not complete the sex/gender item on the study demographic survey.
|
22 Participants
n=69 Participants • Data were not reported for 1 participant in the Sleep Habits arm, who did not complete the sex/gender item on the study demographic survey.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
0 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
0 Participants
n=68 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
0 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
0 Participants
n=68 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
0 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
0 Participants
n=68 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
9 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
21 Participants
n=68 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
|
Race (NIH/OMB)
White
|
19 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
23 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
42 Participants
n=68 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
2 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
5 Participants
n=68 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
0 Participants
n=34 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
0 Participants
n=68 Participants • Data were not reported for 1 participant in each arm (Healthy Habits and Sleep Habits), who did not complete the race item on the study demographic survey.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=32 Participants • Data were not reported for 5 participants in the Healthy Habits arm and 3 participants in the Sleep Habits arm, who did not complete the ethnicity item on the study demographic survey.
|
2 Participants
n=30 Participants • Data were not reported for 5 participants in the Healthy Habits arm and 3 participants in the Sleep Habits arm, who did not complete the ethnicity item on the study demographic survey.
|
7 Participants
n=62 Participants • Data were not reported for 5 participants in the Healthy Habits arm and 3 participants in the Sleep Habits arm, who did not complete the ethnicity item on the study demographic survey.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=32 Participants • Data were not reported for 5 participants in the Healthy Habits arm and 3 participants in the Sleep Habits arm, who did not complete the ethnicity item on the study demographic survey.
|
28 Participants
n=30 Participants • Data were not reported for 5 participants in the Healthy Habits arm and 3 participants in the Sleep Habits arm, who did not complete the ethnicity item on the study demographic survey.
|
55 Participants
n=62 Participants • Data were not reported for 5 participants in the Healthy Habits arm and 3 participants in the Sleep Habits arm, who did not complete the ethnicity item on the study demographic survey.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants • Data were not reported for 5 participants in the Healthy Habits arm and 3 participants in the Sleep Habits arm, who did not complete the ethnicity item on the study demographic survey.
|
0 Participants
n=30 Participants • Data were not reported for 5 participants in the Healthy Habits arm and 3 participants in the Sleep Habits arm, who did not complete the ethnicity item on the study demographic survey.
|
0 Participants
n=62 Participants • Data were not reported for 5 participants in the Healthy Habits arm and 3 participants in the Sleep Habits arm, who did not complete the ethnicity item on the study demographic survey.
|
|
Body Mass Index (BMI)
|
33.25 kg/m^2
STANDARD_DEVIATION 1.19 • n=35 Participants
|
32.68 kg/m^2
STANDARD_DEVIATION 7.93 • n=35 Participants
|
32.96 kg/m^2
STANDARD_DEVIATION 6.68 • n=70 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 7-14 days after surgeryISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Outcome measures
| Measure |
Sleep Habits
n=35 Participants
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
|
Healthy Habits
n=35 Participants
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
1.49 units on a scale
Standard Deviation 1.34
|
1.49 units on a scale
Standard Deviation 1.35
|
PRIMARY outcome
Timeframe: Change from Baseline to 7-14 days after completing the 8 week intervention periodISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms ofinsomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Outcome measures
| Measure |
Sleep Habits
n=35 Participants
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
|
Healthy Habits
n=35 Participants
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
-7.19 units on a scale
Standard Deviation 1.49
|
-2.67 units on a scale
Standard Deviation 1.37
|
PRIMARY outcome
Timeframe: Change Score from Baseline to 6-month Follow-Up PeriodISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.
Outcome measures
| Measure |
Sleep Habits
n=35 Participants
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
|
Healthy Habits
n=35 Participants
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
-6.27 units on a scale
Standard Deviation 1.49
|
-2.96 units on a scale
Standard Deviation 1.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before scheduled surgeryThis questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely. Knee injury and Osteoarthritis Outcome Score (KOOS, knee patients) / Hip disability and Osteoarthritis Outcome Score (HOOS, hip patients) - Pain subscale, assessing the frequency and severity of joint pain. Items are rated on a 5-point Likert scale (None, Mild, Moderate, Severe, Extreme) and the Pain subscale is normalized to a total score from 0 to 100, where 0 = extreme pain/problems and 100 = no pain/problems. Higher scores indicate a better outcome (less pain).
Outcome measures
| Measure |
Sleep Habits
n=35 Participants
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
|
Healthy Habits
n=35 Participants
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.
|
|---|---|---|
|
Hip-Knee Injury and Osteoarthritis Outcome Score - Pain
|
41.38 units on a scale
Standard Deviation 3.35
|
38.07 units on a scale
Standard Deviation 3.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before scheduled surgeryThe PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeThe PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodThe PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionThe PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before schedule surgeryThe PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeThe PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodThe PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionThe PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before scheduled surgeryThe PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeThe PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodThe PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionThe PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before scheduled surgeryThe PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeThe PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodThe PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionThe PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before scheduled surgeryThe PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeThe PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodThe PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionThe PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before scheduled surgeryThe PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeThe PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodThe PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionThe PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before scheduled surgeryThe PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeThe PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodThe PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionThe PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodBlood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionBlood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before scheduled surgeryBlood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeBlood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodBlood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionBlood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before scheduled surgeryBlood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeBlood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodBlood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionBlood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before scheduled surgeryBlood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeBlood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodBlood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionBlood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days before schedule surgeryMedication Monitoring Form will be used to track medication use. Medications will be coded by drug class.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after hospital dischargeMedication Monitoring Form will be used to track medication use. Medications will be coded by drug class.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7-14 days after completing the 8 week intervention periodMedication Monitoring Form will be used to track medication use. Medications will be coded by drug class.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after completing the interventionMedication Monitoring Form will be used to track medication use. Medications will be coded by drug class.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately prior to beginning the interventionThis questionnaire 8-question measure provided before treatment. It will be used to collect information on participants' reasons for treatment as well as their expectations of treatment (e.g., its effectiveness, the amount of effort it will take, confidence in their doctor). Participant will mark answers to each question on a visual analog scale (e.g., from Not Confident at all to Very Confident).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately following the completion of the interventionTreatment Satisfaction Scale is a 10-question measure provided after treatment. It measures participants' perceptions on the treatment's effectiveness, benefits, and influence on quality of life (e.g., improvements in work productivity, mood, etc.). Questions are measured on a 5-point Likert scale from Not at all to Very Much.
Outcome measures
Outcome data not reported
Adverse Events
Sleep Habits
Healthy Habits
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place