NCT04008862

Characteristics and Effectiveness of a Partnership-based Nursing Practice for Patients With Chronic Lung Diseases and Their Families

Extracted Fields (from Registry)
Protocol IDNCT04008862
Registration Date2019-07-05
Statuscompleted
SponsorHelga Jónsdóttir
CountryIceland
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2018-05-28
Last Patient Out2020-12-30
Publicationn
Gender %ALL
Mean Age50 Years -
LLM Classifications (Side-by-Side)
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
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