Physical Attendance Versus Telephone or Video Follow-up for Prevention of Severe Adverse Events in Patients With Non-functioning Pituitary Tumors. A Pragmatic Randomized Controlled Multi-center Non-inferiority Trial.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 812
- 试验地点
- 1
- 主要终点
- Composite outcome of adverse events
研究概览
简要总结
The primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated assessment of pituitary function and imaging in patients with small pituitary tumors (microadenomas).
详细描述
This study intends to investigate the treatment quality, treatment safety, and patient satisfaction of increased use of telephone/video clinics compared to physical attendance during a three year period. Secondly, the study will assess the impact of reducing biochemical assessment by 50 % and explore the possibility of reducing patients with non-functioning pituitary tumors (NFPTs) affiliated to endocrine departments by 10 - 20 %.
Objective
- The primary objective is to compare a phone/video follow-up versus standard follow-up in adults with stable non-functioning pituitary tumors for the risk of admission for acute adrenal crisis, poor visual outcome after pituitary surgery, or admission with hypo- or hypernatremia caused by diabetes insipidus.
- Main secondary objective is to compare yearly endocrine check-up versus endocrine check-up every 6 months in adults with stable non-functioning pituitary tumors for adequate control of hormonal replacement therapy.
- To assess whether hormonal replacement therapy in patients followed by phone/video consultation is non-inferior to patients followed with standard treatment.
- Another secondary objective is to use the collected data to quantify the risk of surgery/radiotherapy of pituitary tumor due to tumor growth or new endocrinopathies in patients with micro-NFPTs.
Design This study is an investigator initiated pragmatic multicenter non-inferiority trial with blinded outcome assessment.
Trial procedure Eligible patients will be approached at the yearly routine visit for information of the trial. Patients fulfilling the inclusion criteria and none of exclusion criteria will offered enrollment in the trial. Patients will be randomized to either at standard treatment, planned yearly in-person visits for the next two years, or the intervention which is planned yearly control by telephone or video contact for the next two years. Following randomization there a no restrictions on patient care. Primary outcome will be assessed from randomization to the last visit (2 years from randomization) by a blinded adjudication committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Adverse events (primary outcome) will be established by a blinded adjudication committee.
A committé of external endocrinologist/ophthalmologist will blinded to participant ID/allocation assess all the participants admissions to hospital and assess wether it qualifies as an event
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-functioning pituitary tumor
- •Diagnosed > 6 months from enrollment, i.e. found on MRI.
排除标准
- •Planned pituitary surgery
- •Planned radiotherapy
- •Poor Danish skills
- •Patient is considered by the treating physician unsuitable for follow-up by telephone or video
研究组 & 干预措施
Telephone-/video follow-up
Yearly routine review of patients status will take place by using telephone- or video consultation.
干预措施: Telephone-/video follow-up (Behavioral)
Standard
Yearly routine review of patients status will take place as an in-person interview
干预措施: In-person follow-up (Behavioral)
结局指标
主要结局
Composite outcome of adverse events
时间窗: Two year period. From allocation including the routine follow-up after two years.
The primary outcome is a composite outcome comprised of the three individual outcomes considered of equal importance to patients and clinicians: Risk of admission for adrenal crisis, risk of admission for severe hypo- or hypernatremia, risk of pituitary surgery with lack of full recovery of vision after surgery.
次要结局
- Desmopressin replacement therapy(At two years follow-up)
- Hormonal replacement therapy(At two years follow-up)
- Thyroid replacement therapy(At two years follow-up)
- Growth hormone replacement therapy(At two years follow-up)