Condition or disease | Intervention/treatment | Phase |
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Pituitary Tumor Benign Surgery | Other: person-centred practice | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | A quasi- experimental study with non-equivalent control group design, pretest-posttest study |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Extended Support Within a Person-centred Practice After Surgery: a Quasi- Experimental Study for Persons With Pituitary Tumours |
Actual Study Start Date : | December 6, 2017 |
Estimated Primary Completion Date : | February 28, 2021 |
Estimated Study Completion Date : | February 28, 2021 |
Arm | Intervention/treatment |
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Person-centred practice
Person-centred care
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Other: person-centred practice
The structure and content of the intervention is constructed on principles for person-centredness. Each patients in the intervention are allocated a hospital-initiated nurse care manager during one year after surgery. Self-management support is primarily conducted between the patient and the nurse care manager. The primary goal of the support is to facilitate patients own resources in managing illness and health education on e.g. physical activity and diet. The support also comprises patient-held documentation and health plan. Other components of the intervention comprise accessibility and continuity which is secured by a structured clinical care pathway with planned care and defined care contacts. The patient has continuous access to the nurse care manager by telephone and face-to-face contact according to a structured follow-up plan. An interdisciplinary team as well as a patient education program constitutes distinct parts of the support during the year after surgery.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eva Jakobsson Ung, professor | +46734028521 | eva.jakobsson@fhs.gu.se |
Sweden | |
Department of Medicine, Sahlgrenska University Hospital | Recruiting |
Gothenburg, Sweden, 413 46 | |
Contact: Eva Jakobsson Ung, professor | |
Sub-Investigator: Gudmundur Johannsson, Professor |
Principal Investigator: | Eva Jakobsson Ung, professor | Göteborg University |
Tracking Information | |||||
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First Submitted Date ICMJE | April 23, 2019 | ||||
First Posted Date ICMJE | April 25, 2019 | ||||
Last Update Posted Date | April 29, 2019 | ||||
Actual Study Start Date ICMJE | December 6, 2017 | ||||
Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Self- perceived psychological wellbeing [ Time Frame: From date of inclusion until the date of one year follow up after surgery ] The outcome is assessed with The Psychological General Well-being scale (PGWB), a questionnaire with 22 items, comprising six subscales: anxiety, depression, positive well-being, self-control, general health and vitality. The Swedish version of the questionnaire is valid. Total score of 132 is an overall score of the values from each item (score 1-6 for each item). Higher value is indicative for better psychological well-being. A sum score for each subscale can be calculated, minimum and maximum score; anxiety (5-30), depression (3-18), positive well-being (4-24), self-control (3-18), general health (3-18) and vitality (4-24).
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Original Primary Outcome Measures ICMJE |
Self- perceived psychological wellbeing [ Time Frame: From date of inclusion until the date of one year follow up after surgery ] The outcome is assessed with The Psychological General Well-being (PGWB) scale, a questionnaire with 22 items, comprising six subscales: anxiety, depression, positive well-being, self-control, general health and vitality. The Swedish version of the questionnaire is valid. Total score of 132 is calculated from 6-point Likert- scales for each item representing excellent psychological well-being. A sum score for each subscale can be calculated.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Extended Support for Persons With Pituitary Tumours After Surgery | ||||
Official Title ICMJE | Extended Support Within a Person-centred Practice After Surgery: a Quasi- Experimental Study for Persons With Pituitary Tumours | ||||
Brief Summary | Patients with pituitary tumours often live with life-long consequences of their disease. Treatment options include surgery, radiotherapy and medical therapy. Symptoms associated with the tumour and/or its treatment affects several areas of life. The year after pituitary surgery constitutes an important time-period with medical evaluations of surgery and decisions on hormonal substitution. The development and evaluation of extended patient support during this time-point is limited. Care based on person-centredness has exclusively been promoted which comprises a care where care providers inquire how patients view their health situation and what their needs, resources, and preferences are. Person-centredness focuses on preserving patient autonomy, function, and well-being and strives to emphasize patient involvement through equalizing power between health care professionals and the patient with the main goal of an enhanced health situation. The aim of the study is to evaluate if a support within a person-centered care practice one year after surgery increases wellbeing for patients with pituitary tumours. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: A quasi- experimental study with non-equivalent control group design, pretest-posttest study Masking: None (Open Label)Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE | Other: person-centred practice
The structure and content of the intervention is constructed on principles for person-centredness. Each patients in the intervention are allocated a hospital-initiated nurse care manager during one year after surgery. Self-management support is primarily conducted between the patient and the nurse care manager. The primary goal of the support is to facilitate patients own resources in managing illness and health education on e.g. physical activity and diet. The support also comprises patient-held documentation and health plan. Other components of the intervention comprise accessibility and continuity which is secured by a structured clinical care pathway with planned care and defined care contacts. The patient has continuous access to the nurse care manager by telephone and face-to-face contact according to a structured follow-up plan. An interdisciplinary team as well as a patient education program constitutes distinct parts of the support during the year after surgery.
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Study Arms ICMJE | Person-centred practice
Person-centred care
Intervention: Other: person-centred practice
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
90 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | February 28, 2021 | ||||
Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Sweden | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03927183 | ||||
Other Study ID Numbers ICMJE | GoPT | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Göteborg University | ||||
Study Sponsor ICMJE | Göteborg University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Göteborg University | ||||
Verification Date | April 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |