Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism

NCT06337825 | Completed

• 1 other identifier: 22-727
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Wearable electronic devices are becoming more prevalent in daily life, as they offer real time information on physiological parameters such as heart rate, activity level, oxygenation, and sleep patterns for their users. These wearable electronic devices are easy to install and offer no major risk or discomfort to the user. Implementation of these technologies into medicine has exponentially grown in the past decade with supporting evidence for their use in cardiovascular disease and sleep medicine. The investigators believe that these devices will be able to capture the changes associated with improvement in non-specific symptoms that have not been previously demonstrated.

Conditions

Primary Hyperparathyroidism; Multinodular Goiter

Outcome Measures

Primary Outcomes (8)

• Change in resting heart rate over time among study participants as monitored by fitness tracker

  To assess the change in resting heart rate before and after parathyroidectomy in patients with Primary hyperparathyroidism

  7 months

• Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker

  To assess the change in number of awakenings during sleep before and after parathyroidectomy in patients with Primary hyperparathyroidism

  7 months

• Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker

  To assess the change in % Deep Sleep over Total Sleep Minutes before and after parathyroidectomy in patients with Primary hyperparathyroidism

  7 months

• Change in steps over time among study participants as monitored by fitness tracker

  To assess the change in steps before and after parathyroidectomy in patients with Primary hyperparathyroidism

  7 months

• Change in total active minutes over time among study participants as monitored by fitness tracker

  To assess the change in total active minutes before and after parathyroidectomy in patients with Primary hyperparathyroidism

  7 months

• Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker

  To assess the change in % Active Calorie over Total Calories before and after parathyroidectomy in patients with Primary hyperparathyroidism

  7 months

• Change in glucose levels (HbA1C)

  To assess the change glucose control before and after parathyroidectomy in patients with Primary hyperparathyroidism.

  7 months

• Correlation of Quality of Life surveys with the PROMPT survey

  To correlate the measurements of patient health parameters with quality of life surveys before and after parathyroidectomy. This survey is comprised of 30 questions each with a 1 - 5 rating scale where lower scores indicate less pain, fatigue, soreness and higher scores indicate more fatigue, pain, soreness etc.

  7 months

Study Arms (2)

40 patients with primary hyperparathyroidism

patients undergoing parathyroidectomy for primary hyperparathyroidism

Behavioral: Activity Tracker (Fitbit); Diagnostic Test: HbA1C; Behavioral: The PROMPT Questionnaire

40 patients with multinodular goiters

patients undergoing thyroidectomy for multinodular goiter

Behavioral: Activity Tracker (Fitbit); Diagnostic Test: HbA1C; Behavioral: The PROMPT Questionnaire

Interventions

Activity Tracker (Fitbit) BEHAVIORAL

Wearable, activity tracker

40 patients with multinodular goiters; 40 patients with primary hyperparathyroidism

HbA1C DIAGNOSTIC_TEST

Average blood glucose (sugar) levels reported as a percentage

40 patients with multinodular goiters; 40 patients with primary hyperparathyroidism

The PROMPT Questionnaire BEHAVIORAL

The PROMPT Questionnaire which is a 30-question previously validated assessment for non-specific symptoms in PHPT, will be administered to patients preoperatively and at 2-weeks and 6-months postoperatively

40 patients with multinodular goiters; 40 patients with primary hyperparathyroidism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred by other physicians for surgical treatment of PHPT and MNG will be identified in the outpatient schedule of our six endocrine surgeons at the Department of Endocrine Surgery, Endocrine and Metabolism Institute. The research team will be introduced to the patients via My Chart where we will request permission for a phone call to discuss the research study. Once they agree to participate, the recruitment will be done at the outpatient clinic in the Endocrine and Metabolism Institute at Main Campus on the day of their appointment. The need for surgery will be made by the treating surgeon with no involvement of the research team. The recruitment will be done by a member of the research team at the endocrine surgery center (F-20).

You may qualify if:

• Study group: Consecutive patients older than 18 years old who will undergo PTX for PHPT. The indications and need for surgery will be independent from the research team.
• Control group: Consecutive patients older than 18 years old who will undergo thyroidectomy for multinodular goiter (MNG). The indications and need for surgery will be independent from the research team.

You may not qualify if:

• Patients with recurrent or persistent PHPT will not be included.
• Patients who are included but have evidence of recurrent or persistent PHPT based on six-month laboratory workup will be excluded from the final analysis (\<5% expected)4.
• Established diagnosis of thyroid cancer or Graves' disease.
• Musculoskeletal or neurologic disorders that affect the patient's activity level.
• Cardiac arrhythmias that would interfere with the wearable electronic device measurement.
• Sleep apnea and other sleep disturbances undergoing concurrent treatment.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Judy Jin, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 29, 2024
• Study Start: July 19, 2022
• Primary Completion: March 12, 2024
• Study Completion: June 29, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)