Obesity
Conditions
Keywords
ESG, Hybrid APC
Brief summary
This study is being done to evaluate the safety and effectiveness of combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) for weight loss and improvement in obesity-related co-morbidities compared to ESG alone in participants with a BMI ≥ 30 and ≤40 kg/m² who have failed to achieve and maintain weight loss with a non-surgical program.
Interventions
DEVICEApollo ESG with ERBE HAPC
Utilizing two approved devices in combination to assess durability of suturing.
DEVICEApollo ESG
Using only Apollo ESG as approved per label.
Sponsors
Erbe Elektromedizin GmbH
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Randomized
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI ≥ 30 and ≤40 kg/m² * Willingness to comply with the substantial lifelong dietary restrictions required by the procedure. * History of failure with non-surgical weight-loss methods. * Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling. * Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow-up visits. * Ability to give informed consent. * Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
Exclusion criteria
* History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy). * Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions. * Prior open or laparoscopic bariatric surgery. * Prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery. * Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer, or specific inflammatory disease such as Crohn's disease or celiac disease. * Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses. * Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinal metaplasia), history of familial and nan-familial adenomatous syndromes. * A gastric mass or gastric polyps \> 1 cm in size. * A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms. * A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope. * Achalasia or any other severe esophageal motility disorder * Severe coagulopathy. * Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C≥9. * Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy. * Chronic abdominal pain. * Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation. * Hepatic insufficiency or cirrhosis. * Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing. * Active psychological issues preventing participation in a life-style modification program as determined by a psychologist. * Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up. * Patients receiving daily prescribed treatment with high dose aspirin (\> 81mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants. * Patients who are unable or unwilling to take prescribed proton pump inhibitor medication. * Patients who are pregnant or breast-feeding. * Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months. * Subjects with severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs. * Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications. * Subjects who are taking corticosteroids, immunosuppressants, and narcotics. * Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease. * Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer. * Diagnosis of autoimmune connective tissue disorder (e.g. Systemic lupus erythematosus, scleroderma) or immunocompromised. * Specific diagnosed genetic disorder such as Prader Willi syndrome. * Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating. * Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism. * At the discretion of the PI for subject safety * If minority inclusion population target of 10% has not been reached by the 90% enrollment mark (example 21 of 24 subjects), the remaining enrollments will be reserved for minority subjects (example 3 of 24 subjects).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Durability | 6 months | The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Endoscopic scale runs from 0 to 3. A lower score indicates less durability and a higher score indicates greater durability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Excess Weight Loss (%EWL) | 6 and 12 month | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent excess weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m\^2) |
| Blood Pressure | 6 month | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Blood pressure scores analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). |
| Percentage of Glycated Hemoglobin (% HbA1c) | 6 month | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis |
| Questionnaire: Short Form (36) Health Survey [SF-36] | 6 month | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 8 quality of life domains assessed, domains scores range 0-100 with a lower score indicating a worse outcome, and a higher score indicating a better outcome. |
| Percent Total Body Weight Loss (%TBWL) | 6 month | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent total body weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). Total body weight loss is calculated as follows: Total Body Weight Loss (%) = \[ (Starting Weight - Current Weight) / Starting Weight \] × 100 |
| Questionnaire: Patient Health Questionnaire-9 (PHQ-9) | 6 month | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Score range 0-27, with a higher score indicating more severe symptoms and a lower score indicating less severe or no symptoms. |
| Questionnaire: Eating Behavior | 6 month | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Scored across three behavioral domains, higher scores in each subscale indicate a greater tendency towards that particular eating behavior. Cognitive Restraint Score range 6-28 Uncontrolled Eating Score range 9-36 Emotional Eating Score range 3-12 |
| Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL) | 6 month | Compared between treatment arms by Pearson Chi-square test. % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m\^2) |
| Binary Outcome: Incidence of Esophagitis | 6 month | Compared between treatment arms by Pearson Chi-square test. |
| Questionnaire: Impact of Weight on Quality of Life (IWQOL) | 6 month | Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 5 quality of life domains are scored, a higher score indicates higher quality of life relative to that domain and lower score indicates worse quality of life relative to that domain. Physical function domain (11 items scored 1-5) total scores ranging 11-55 Self-esteem domain (seven items scored 1-5) total scores ranging 7-35 Sexual life domain (four items each scored 1-5) total scores ranging 4-20 Public distress domain (five items each scored 1-5) total scores ranging 5-25 Work-related domain (four items each scored 1-5) total scores ranging 4-20 |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred at a single center, Mayo Clinic Rochester. Recruitment was primarily achieved through direct advertising leading subjects to self-refer, as well as physician referrals. 45 patients were enrolled, 24 were randomized and underwent study treatment either in the ESG arm or the ESG-HAPC arm. The last patient was enrolled in November of 2023 and the last treatment procedure was completed in January of 2024.
Pre-assignment details
Of the 45 enrolled participants only 24 moved forward to randomization and treatment. Reasons for exclusion included non-qualifying BMI, disqualifying psychological intake findings, findings on laboratory testing or MRI, and patient refusal to complete screening activities.
Participants by arm
| Arm | Count |
|---|---|
| Control Group: ESG Subjects will undergo ESG utilizing approved device alone | 12 |
| Treatment Group: ESG + HAPC Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment Group: ESG + HAPC | Total | Control Group: ESG |
|---|---|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 9.2 | 45.5 years STANDARD_DEVIATION 11.27 | 38.9 years STANDARD_DEVIATION 6.2 |
| BMI | 36.6 kg/m² STANDARD_DEVIATION 2.1 | 36.6 kg/m² STANDARD_DEVIATION 2.22 | 36.6 kg/m² STANDARD_DEVIATION 2.4 |
| Current alcohol use | 6 Participants | 16 Participants | 10 Participants |
| Current smoker | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 21 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hyperlipidemia | 3 Participants | 6 Participants | 3 Participants |
| Hypertension | 3 Participants | 3 Participants | 0 Participants |
| Mood Disorder | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 24 Participants | 12 Participants |
| Region of Enrollment United States | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Female | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 0 Participants |
| Sleep Apnea | 2 Participants | 2 Participants | 0 Participants |
| Type 2 diabetes mellitus | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 6 / 12 | 10 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Durability
The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Endoscopic scale runs from 0 to 3. A lower score indicates less durability and a higher score indicates greater durability.
Time frame: 6 months
Population: One participant in the ESG arm elected not to undergo the endoscopy at which the durability assessment is performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: ESG | Durability | Proximal Stomach - Tubular form | 1.2 Score on a scale | Standard Deviation 0.1 |
| Control Group: ESG | Durability | Proximal stomach - Bridging fibrosis | 1.4 Score on a scale | Standard Deviation 0.7 |
| Control Group: ESG | Durability | Proximal stomach - accommodation to insufflation | 1.4 Score on a scale | Standard Deviation 0.7 |
| Control Group: ESG | Durability | Mid-stomach - tubular form | 2.8 Score on a scale | Standard Deviation 0.4 |
| Control Group: ESG | Durability | Mid Stomach - bridging fibrosis | 2.8 Score on a scale | Standard Deviation 0.4 |
| Control Group: ESG | Durability | Mid Stomach - accommodation to insufflation | 2.8 Score on a scale | Standard Deviation 0.4 |
| Control Group: ESG | Durability | Distal Stomach - tubular form | 1.3 Score on a scale | Standard Deviation 0.6 |
| Control Group: ESG | Durability | Distal stomach - bridging fibrosis | 1.5 Score on a scale | Standard Deviation 0.7 |
| Control Group: ESG | Durability | Distal stomach - accommodation to insufflation | 1.2 Score on a scale | Standard Deviation 0.4 |
| Treatment Group: ESG + HAPC | Durability | Distal stomach - bridging fibrosis | 2.0 Score on a scale | Standard Deviation 0.7 |
| Treatment Group: ESG + HAPC | Durability | Distal Stomach - tubular form | 2.2 Score on a scale | Standard Deviation 0.6 |
| Treatment Group: ESG + HAPC | Durability | Proximal Stomach - Tubular form | 3.0 Score on a scale | Standard Deviation 0.12 |
| Treatment Group: ESG + HAPC | Durability | Mid Stomach - bridging fibrosis | 1.9 Score on a scale | Standard Deviation 0.7 |
| Treatment Group: ESG + HAPC | Durability | Proximal stomach - Bridging fibrosis | 3.0 Score on a scale | Standard Deviation 0 |
| Treatment Group: ESG + HAPC | Durability | Distal stomach - accommodation to insufflation | 1.9 Score on a scale | Standard Deviation 0.5 |
| Treatment Group: ESG + HAPC | Durability | Proximal stomach - accommodation to insufflation | 3.0 Score on a scale | Standard Deviation 0 |
| Treatment Group: ESG + HAPC | Durability | Mid Stomach - accommodation to insufflation | 1.8 Score on a scale | Standard Deviation 0.6 |
| Treatment Group: ESG + HAPC | Durability | Mid-stomach - tubular form | 1.8 Score on a scale | Standard Deviation 0.7 |
Comparison: Scores from the proximal stomach, mid-stomach and distal stomach in the control and treatment groups were analyzed to determine if there was a significant difference between the mean difference in durability scores for the control and treatment groups.p-value: <0.0195% CI: [0.31, 0.74]t-test, 2 sided
Secondary
Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL)
Compared between treatment arms by Pearson Chi-square test. % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m\^2)
Time frame: 6 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group: ESG | Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL) | 11 Participants |
| Treatment Group: ESG + HAPC | Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL) | 12 Participants |
p-value: 0.307Chi-squared
Secondary
Binary Outcome: Incidence of Esophagitis
Compared between treatment arms by Pearson Chi-square test.
Time frame: 6 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group: ESG | Binary Outcome: Incidence of Esophagitis | 0 Participants |
| Treatment Group: ESG + HAPC | Binary Outcome: Incidence of Esophagitis | 0 Participants |
Secondary
Blood Pressure
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Blood pressure scores analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index).
Time frame: 6 month
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control Group: ESG | Blood Pressure | Systolic | 113.8 mm HG |
| Control Group: ESG | Blood Pressure | Diastolic | 73.9 mm HG |
| Treatment Group: ESG + HAPC | Blood Pressure | Systolic | 119.8 mm HG |
| Treatment Group: ESG + HAPC | Blood Pressure | Diastolic | 76.3 mm HG |
p-value: 0.271ANCOVA
Secondary
Percentage of Glycated Hemoglobin (% HbA1c)
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis
Time frame: 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: ESG | Percentage of Glycated Hemoglobin (% HbA1c) | 4.9 Percentage | Standard Deviation 0.28 |
| Treatment Group: ESG + HAPC | Percentage of Glycated Hemoglobin (% HbA1c) | 5.1 Percentage | Standard Deviation 0.22 |
p-value: 0.29ANCOVA
Secondary
Percent Excess Weight Loss (%EWL)
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent excess weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). % EWL = (actual weight lost / excess body weight) x 100 Where excess body weight represents the difference in starting weight and ideal weight (weight corresponding to a body mass index of 25 kg/m\^2)
Time frame: 6 and 12 month
Population: All 24 patients completed their weigh in at 6 months, 2 patients in the ESG arm did not weigh in at 12 months (one due to patient withdrawal, one due to patient noncompliance).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: ESG | Percent Excess Weight Loss (%EWL) | 6 Months | 101.5 Percentage | Standard Deviation 73.68 |
| Control Group: ESG | Percent Excess Weight Loss (%EWL) | 12 Months | 125.49 Percentage | Standard Deviation 87.96 |
| Treatment Group: ESG + HAPC | Percent Excess Weight Loss (%EWL) | 6 Months | 88.69 Percentage | Standard Deviation 70.92 |
| Treatment Group: ESG + HAPC | Percent Excess Weight Loss (%EWL) | 12 Months | 187.15 Percentage | Standard Deviation 200.95 |
p-value: 0.757ANCOVA
Secondary
Percent Total Body Weight Loss (%TBWL)
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Percent total body weight loss was analyzed for variance between treatment and control groups accounting for gender and starting obesity class (determined by starting body mass index). Total body weight loss is calculated as follows: Total Body Weight Loss (%) = \[ (Starting Weight - Current Weight) / Starting Weight \] × 100
Time frame: 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: ESG | Percent Total Body Weight Loss (%TBWL) | 19.5 Percentage | Standard Deviation 6.2 |
| Treatment Group: ESG + HAPC | Percent Total Body Weight Loss (%TBWL) | 18.8 Percentage | Standard Deviation 4.4 |
p-value: 195% CI: [19.125, 19.125]ANCOVA
Secondary
Questionnaire: Eating Behavior
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Scored across three behavioral domains, higher scores in each subscale indicate a greater tendency towards that particular eating behavior. Cognitive Restraint Score range 6-28 Uncontrolled Eating Score range 9-36 Emotional Eating Score range 3-12
Time frame: 6 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: ESG | Questionnaire: Eating Behavior | Cognitive restraint score | 18.4 Score on a scale | Standard Deviation 2.4 |
| Control Group: ESG | Questionnaire: Eating Behavior | Uncontrolled eating score | 14.1 Score on a scale | Standard Deviation 4.1 |
| Control Group: ESG | Questionnaire: Eating Behavior | Emotional eating score | 5.3 Score on a scale | Standard Deviation 2.3 |
| Treatment Group: ESG + HAPC | Questionnaire: Eating Behavior | Cognitive restraint score | 18.8 Score on a scale | Standard Deviation 3 |
| Treatment Group: ESG + HAPC | Questionnaire: Eating Behavior | Uncontrolled eating score | 11.6 Score on a scale | Standard Deviation 3.1 |
| Treatment Group: ESG + HAPC | Questionnaire: Eating Behavior | Emotional eating score | 4.2 Score on a scale | Standard Deviation 1.3 |
p-value: 0.91ANCOVA
Secondary
Questionnaire: Impact of Weight on Quality of Life (IWQOL)
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 5 quality of life domains are scored, a higher score indicates higher quality of life relative to that domain and lower score indicates worse quality of life relative to that domain. Physical function domain (11 items scored 1-5) total scores ranging 11-55 Self-esteem domain (seven items scored 1-5) total scores ranging 7-35 Sexual life domain (four items each scored 1-5) total scores ranging 4-20 Public distress domain (five items each scored 1-5) total scores ranging 5-25 Work-related domain (four items each scored 1-5) total scores ranging 4-20
Time frame: 6 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: ESG | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Self-esteem score | 14 Score on a scale | Standard Deviation 4.8 |
| Control Group: ESG | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Public distress score | 5.4 Score on a scale | Standard Deviation 1.5 |
| Control Group: ESG | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Sexual life score | 7.3 Score on a scale | Standard Deviation 3 |
| Control Group: ESG | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Work-related score | 4 Score on a scale | Standard Deviation 0.7 |
| Control Group: ESG | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Physical function score | 13.08 Score on a scale | Standard Deviation 3.6 |
| Treatment Group: ESG + HAPC | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Work-related score | 4.08 Score on a scale | Standard Deviation 0.3 |
| Treatment Group: ESG + HAPC | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Physical function score | 12.91 Score on a scale | Standard Deviation 2.5 |
| Treatment Group: ESG + HAPC | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Self-esteem score | 12 Score on a scale | Standard Deviation 6.3 |
| Treatment Group: ESG + HAPC | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Sexual life score | 6.6 Score on a scale | Standard Deviation 3.1 |
| Treatment Group: ESG + HAPC | Questionnaire: Impact of Weight on Quality of Life (IWQOL) | Public distress score | 5.25 Score on a scale | Standard Deviation 0.6 |
p-value: 0.41ANCOVA
Secondary
Questionnaire: Patient Health Questionnaire-9 (PHQ-9)
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. Score range 0-27, with a higher score indicating more severe symptoms and a lower score indicating less severe or no symptoms.
Time frame: 6 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group: ESG | Questionnaire: Patient Health Questionnaire-9 (PHQ-9) | 1.8 Score on a scale |
| Treatment Group: ESG + HAPC | Questionnaire: Patient Health Questionnaire-9 (PHQ-9) | 1.1 Score on a scale |
p-value: 0.53ANCOVA
Secondary
Questionnaire: Short Form (36) Health Survey [SF-36]
Compared between treatment arms using ANCOVA with adjustment for the same variables specified in the primary analysis. 8 quality of life domains assessed, domains scores range 0-100 with a lower score indicating a worse outcome, and a higher score indicating a better outcome.
Time frame: 6 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: ESG | Questionnaire: Short Form (36) Health Survey [SF-36] | Physical Functioning | 98.3 Score on a scale | Standard Deviation 3.3 |
| Control Group: ESG | Questionnaire: Short Form (36) Health Survey [SF-36] | Role Limitations Due to Physical Health | 97.9 Score on a scale | Standard Deviation 7.2 |
| Control Group: ESG | Questionnaire: Short Form (36) Health Survey [SF-36] | Bodily Pain | 87.7 Score on a scale | Standard Deviation 16.6 |
| Control Group: ESG | Questionnaire: Short Form (36) Health Survey [SF-36] | General Health Perceptions | 77.5 Score on a scale | Standard Deviation 13.1 |
| Control Group: ESG | Questionnaire: Short Form (36) Health Survey [SF-36] | Vitality (Energy and Fatigue) | 60.4 Score on a scale | Standard Deviation 19.1 |
| Control Group: ESG | Questionnaire: Short Form (36) Health Survey [SF-36] | Social Functioning | 89.6 Score on a scale | Standard Deviation 19.1 |
| Control Group: ESG | Questionnaire: Short Form (36) Health Survey [SF-36] | Role Limitations Due to Emotional Problems | 88.88 Score on a scale | Standard Deviation 29.6 |
| Control Group: ESG | Questionnaire: Short Form (36) Health Survey [SF-36] | Emotional well-being | 81.7 Score on a scale | Standard Deviation 15.8 |
| Treatment Group: ESG + HAPC | Questionnaire: Short Form (36) Health Survey [SF-36] | Emotional well-being | 86.7 Score on a scale | Standard Deviation 13.2 |
| Treatment Group: ESG + HAPC | Questionnaire: Short Form (36) Health Survey [SF-36] | Physical Functioning | 89.6 Score on a scale | Standard Deviation 14.5 |
| Treatment Group: ESG + HAPC | Questionnaire: Short Form (36) Health Survey [SF-36] | Vitality (Energy and Fatigue) | 75.4 Score on a scale | Standard Deviation 13.2 |
| Treatment Group: ESG + HAPC | Questionnaire: Short Form (36) Health Survey [SF-36] | Role Limitations Due to Physical Health | 93.8 Score on a scale | Standard Deviation 21.7 |
| Treatment Group: ESG + HAPC | Questionnaire: Short Form (36) Health Survey [SF-36] | Role Limitations Due to Emotional Problems | 100 Score on a scale | Standard Deviation 0 |
| Treatment Group: ESG + HAPC | Questionnaire: Short Form (36) Health Survey [SF-36] | Bodily Pain | 80.6 Score on a scale | Standard Deviation 22.7 |
| Treatment Group: ESG + HAPC | Questionnaire: Short Form (36) Health Survey [SF-36] | Social Functioning | 89.6 Score on a scale | Standard Deviation 17.5 |
| Treatment Group: ESG + HAPC | Questionnaire: Short Form (36) Health Survey [SF-36] | General Health Perceptions | 79.2 Score on a scale | Standard Deviation 7.9 |
p-value: 0.72ANCOVA