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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

Change Score from Baseline to 6-month Follow-Up Period

Results posted on

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

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

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

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 surgery

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.

Outcome measures

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 period

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 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

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 Period

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.

Outcome measures

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 surgery

This 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

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 surgery

The 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 discharge

The 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 period

The 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 intervention

The 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 surgery

The 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 discharge

The 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 period

The 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 intervention

The 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 surgery

The 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 discharge

The 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 period

The 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 intervention

The 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 surgery

The 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 discharge

The 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 period

The 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 intervention

The 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 surgery

The 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 discharge

The 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 period

The 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 intervention

The 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 surgery

The 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 discharge

The 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 period

The 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 intervention

The 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 surgery

The 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 discharge

The 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 period

The 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 intervention

The 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 period

Blood 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 intervention

Blood 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 surgery

Blood 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 discharge

Blood 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 period

Blood 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 intervention

Blood 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 surgery

Blood 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 discharge

Blood 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 period

Blood 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 intervention

Blood 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 surgery

Blood 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 discharge

Blood 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 period

Blood 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 intervention

Blood 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 surgery

Medication 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 discharge

Medication 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 period

Medication 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 intervention

Medication 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 intervention

This 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 intervention

Treatment 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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy Habits

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sara Nowakowski

Baylor College of Medicine

Phone: 4095390230

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place