| Protocol ID | NCT04008862 |
| Registration Date | 2019-07-05 |
| Status | completed |
| Sponsor | Helga Jónsdóttir |
| Country | Iceland |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2018-05-28 |
| Last Patient Out | 2020-12-30 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 50 Years - |
NCT04008862
Characteristics and Effectiveness of a Partnership-based Nursing Practice for Patients With Chronic Lung Diseases and Their Families
| Field |
GLM
glm-5.1 6686ms / 9370 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5182ms / 10660 tok |
OPENAI
gpt-4o Thinking: o3 3111ms / 9225 tok |
Review |
|---|---|---|---|---|
| rct_type |
N/A
cross-over RCT → N/A
shaky reasoning✓ Unanimous
Initial: cross-over RCT
Requery: N/A — The trial design lacks randomization (Allocation is 'NA') and follows a sequential interventional model rather than assigning participants to different comparative arms.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study has Allocation listed as 'NA' and uses a sequential intervention model without any description of randomization design.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — No randomization design described in the trial.
|
OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | respiratory | respiratory | respiratory | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility |
fully powered RCT
feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: fully powered RCT — The study has an enrollment of 60 and focuses on clinical effectiveness outcomes such as Health Related Quality of Life and hospital admissions rather than feasibility metrics.
|
fully powered RCT
feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: fully powered RCT — This is a sequential intervention study with n=60 participants focusing on clinical effectiveness outcomes like health-related quality of life and hospital admissions, suggesting it's designed as a fully powered trial rather than a pilot study.
|
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — The trial has an enrollment of 60 and measures clinical outcomes like Health Related Quality of Life, suggesting it is designed for clinical effectiveness and likely powered.
|
OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex |
yes
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is a single-modality behavioral intervention (partnership-based nursing practice) involving multiple sessions and educational conversations but does not combine distinct intervention types from different categories.
|
yes
yes → yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The partnership-based nursing practice explicitly combines multiple distinct components including behavioral/psychological support (partnership conversations, family involvement), educational elements (empirical knowledge about COPD, symptom management), clinical care components (palliative care, GOLD guidelines), and organizational elements (interdisciplinary collaboration) that work together as an integrated holistic approach.
Thinking: yes — The intervention combines behavioral/psychological support, patient education, and care coordination components that interact through a partnership-based framework delivered by interdisciplinary teams.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention involves partnership-based nursing practice combining behavioral elements, empirical knowledge of COPD, symptom management, and interdisciplinary collaboration, making it a multi-component approach.
Thinking: yes — The partnership-based nursing practice combines nurse-led organizational care (out-patient/home visits), educational components (disease and inhaler instruction) and behavioral/psychological support (motivational conversations, family involvement), thus integrating multiple interacting components from different categories.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | yes | yes | yes | OK |
| intervention_education | yes | yes | yes | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | yes | yes | yes | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |