A Study of Behavioural Change in Elderly Patients With Chronic Obstructive Pulmonary Disease on Long-term Home Oxygen Therapy Combined With Mild Cognitive Impairment Impairment: a Randomised Controlled Trial
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Yuanjiao Yan

 
 
 
 
The Research Plan  
 
 
The Official Title of the study： 
A study of behavioural changes in long-term home oxygen therapy in elderly  
patients with chronic obstructive pulmonary disease combined with mild  
cognitive impairment 
 
 
date of the document: 
9 May 2022

 
 
The Research Plan  
1 Research Background  
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of 
death globally, affecting up to 14% of individuals over 65 years old1. This results in a 
significant burden on healthcare systems and the global economy, with the economic 
cost of COPD projected to exceed $4.3 trillion by 20502. Persistent hypoxemia and 
systemic inflammation in COPD have been shown to accelerate lung function decline. 
Additionally, accumulating evidence suggests these factors may contribute to cognitive 
impairment through hypoxia-induced neuronal damage1. COPD has been identified as 
an independent risk factor for cognitive impairment, with disease duration correlating 
directly with an increased risk of developing mild cognitive impairment (MCI) 2  . 
Research indicates that 25% of COPD patients experience MCI, a rate notably higher 
than the 13% prevalence in the general population3. MCI, a precursor to dementia4, is 
characterized by executive dysfunction, memory deficits, and impairments in attention, 
orientation, and executive function5. These cognitive deficits significantly affect the 
self-management capabilities of elderly COPD patients with MCI, influencing 
medication adherence and long-term oxygen therapy (LTOT) compliance. As a result, 
a detrimental cycle of hypoxemia and cognitive decline may be perpetuated6.  
LTOT, when administered for at least 15 hours daily, has been shown to 
significantly improve blood oxygen levels in elderly COPD patients with MCI9. This  
  
 
1 Chen, X., Yu, Z., Liu, Y., Zhao, Y., Li, S., & Wang, L. (2024). Chronic obstructive pulmonary disease as a risk factor for cognitive 
impairment: a systematic review and meta-analysis. BMJ open respiratory research, 11(1), e001709.  
2 GIULI C, PAPA R, LATTANZIO F, et al. The Effects of Cognitive Training for Elderly:Results from My Mind Project [J]. Rejuvenation 
Res, 2016: 485-94.  
3 Yohannes, A. M., Chen, W., Moga, A. M., Leroi, I., & Connolly, M. J. (2017). Cognitive Impairment in Chronic 
Obstructive Pulmonary Disease and Chronic Heart Failure: A Systematic Review and Meta-analysis of Observational 
Studies. Journal of the American Medical Directors Association, 18(5), 451.e1–451.e11.  
4 Petersen, R. C., Lopez, O., Armstrong, M. J., Getchius, T. S. D., Ganguli, M., Gloss, D., Gronseth, G. S., Marson,  
D., Pringsheim, T., Day, G. S., Sager, M., Stevens, J., & Rae-Grant, A. (2018). Practice guideline update summary: 
Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation 
Subcommittee of the American Academy of Neurology. Neurology, 90(3), 126–135.  
5 CORRADO A, RENDA T, BERTINI S. Long-term oxygen therapy in COPD: evidences and open questions of 
current indications [J]. Monaldi Arch Chest Dis, 2010, 73(1): 34-43  
6 Baird, C., Lovell, J., Johnson, M., Shiell, K., & Ibrahim, J. E. (2017). The impact of cognitive impairment on 
selfmanagement in chronic obstructive pulmonary disease: A systematic review. Respiratory medicine, 129, 130–
139. 9 Mermit Çilingir B, Günbatar H, Çilingir V. Cognitive dysfunctionamong patients in chronic obstructive 
pulmonary  

 
1 
Chen, S., Kuhn, M., Prettner, K., Yu, F., Yang, T., Bärnighausen, T., Bloom, D. E., & Wang, C. (2023). The 
global economic burden of chronic obstructive pulmonary disease for 204 countries and territories in 2020-50: a 
healthaugmented macroeconomic modelling study. The Lancet. Global health, 11(8), e1183–e1193.  
2 
Boers, E., Barrett, M., Su, J. G., Benjafield, A. V., Sinha, S., Kaye, L., Zar, H. J., Vuong, V., Tellez, D., Gondalia, 
R., Rice, M. B., Nunez, C. M., Wedzicha, J. A., & Malhotra, A. (2023). Global Burden of Chronic Obstructive 
Pulmonary Disease Through 2050. JAMA network open, 6(12), e2346598.  
therapy effectively alleviates cognitive impairment, particularly in memory and 
attention, and may partially enhance comfort, exercise tolerance, and sleep quality10. 
However, adherence to LTOT remains suboptimal due to insufficient awareness of its 
benefits11. Health education interventions are essential for enhancing patient knowledge 
and improving COPD management12. Nurse-led educational interventions have been 
shown to provide personalized information, engage patients in decision-making, and 
improve treatment adherence and health outcomes. These interventions are also 
costeffective 7 . However, existing research typically focuses on a single condition 
(COPD or MCI) and neglects the interactions between co-morbidities. Additionally, 
many studies rely on "one-way" educational methods, such as brochure distribution, 
which are not grounded in behavioral change theories and fail to address cognitive-
behavioral factors influencing LTOT adherence in MCI patients8 . Consequently, the 
impact of these interventions is often short-lived 9  . Furthermore, contemporary 
educational interventions, grounded in traditional theoretical frameworks (e.g., health 
beliefs theory, knowledge-attitude-behavior theory), improve health behaviors and 
literacy but often overlook participants’ physical and mental capabilities, including their 
ability to monitor health effectively10.11  
 
7  Michael Doherty,Wendy Jenkins,Hugh H. Richardson,Aliya Sarmanova,Abhishek Abhishek,Deborah 
Ashton,Christine Barclay,Sally Doherty,Lelia Duley,Rachael Hatton,Frances Rees,M Stevenson, & Weiya Zhang 
(2018). Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a 
treatto-target urate-lowering strategy versus usual care for gout: a randomised controlled trial. The Lancet, 392 
(10156), 1403-1412.  
8 Baker, E., & Fatoye, F. (2017). Clinical and cost effectiveness of nurse-led self-management interventions for 
patients with copd in primary care: A systematic review. International journal of nursing studies, 71, 125–138.  
  
9 DOĞAN U, OVAYOLU N. The effects of health education given by nurses to COPD patients on the daily oxygen 
concentrator usage time [J]. Adv Respir Med, 2017, 85(1): 15-21.  
10 YANG L, QIULIZHU, XUEMEISHEN, XIAOYINGZHU, YULANYANG, LIUGAO, WEILI, MINGHUI.  
Effect of a comprehensive health education program on pre-hospital delay intentions in high-risk stroke population 
and caregivers [J]. Quality of life research: An international journal of quality of life aspects of treatment, care and 
rehabilitation, 2017, 26(8).  
11 Guo, X., Men, F., Han, X., & Wang, Z. (2021). The efficacy of continuous nursing care for patients with chronic 
obstructive pulmonary disease: A randomized controlled trial protocol. Medicine, 100(2), e23974.  

 
Michie et al. argue that successful behavior change requires both physical and  
  
disease: effects ofexacerbation and long-term oxygen therapy [ J]. Clin Respir J,2020,14(12):1137-1143. 10  Mermit 
Çilingir B, Günbatar H, Çilingir V. Cognitive dysfunctionamong patients in chronic obstructive pulmonary disease: 
effects ofexacerbation and long-term oxygen therapy [ J]. Clin Respir J,2020,14(12):1137-1143. 11 Gauthier A, 
Bernard S, Bernard E, Simard S, Maltais F, Lacasse Y. Adherence to long-term oxygen therapy in patients with 
chronic obstructive pulmonary disease. Chron Respir Dis. 2019 Jan-Dec;16:1479972318767724. 12 Vincent S. 
Fan,Dennis E. Niewoehner, & Robert A. Lew (2012). A Comprehensive Care Management Program to Prevent 
Chronic Obstructive Pulmonary Disease Hospitalizations. Annals of Internal Medicine, 157 (7), 530-530.  
mental capabilities, alongside the ability to perform the desired behavior. To address 
this, they developed the Behaviour Change Wheel (BCW) theory, based on the COMB 
model (Competence-Opportunity-Motivation) 12 . This model identifies competence, 
opportunity, and motivation as the primary drivers of behavior and provides a 
comprehensive framework for analyzing internal and external factors influencing 
behavior change. The BCW theory designs interventions aimed at fostering the 
emergence and modification of healthy behaviors. In a study by Chen et al., BCW 
theory was used to improve dietary adherence among patients with metabolic 
syndrome 13  . Similarly, Cavalieri et al. applied BCW theory to reduce sedentary 
behavior in COPD patients, achieving positive outcomes 14  . These studies further 
support the cross-disease applicability of the BCW theory, particularly for elderly 
COPD patients with comorbid MCI.  
This study developed a nurse-led, BCW theory-based educational intervention to 
evaluate its impact on LTOT implementation. The intervention targeted adherence, 
equipment hygiene, safe oxygen use, and self-monitoring, while assessing health beliefs 
and multidimensional outcomes (cognitive function, ventilatory parameters, and 
activities of daily living) in elderly COPD-MCI patients.  
 
12 MICHIE S, VAN STRALEN M M, WEST R. The behaviour change wheel: a new method for characterising and 
designing behaviour change interventions [J]. Implement Sci, 2011, 6: 42.  
13 Chen, D., Shao, J., Zhang, H., Wu, J., Xue, E., Guo, P., Tang, L., Cui, N., Wang, X., Chen, L., & Ye, Z. (2023). 
Development of an individualized WeChat mini program-based intervention to increase adherence to dietary 
recommendations applying the behaviour change wheel among individuals with metabolic syndrome. Annals of 
medicine, 55(2), 2267587.  
14  Crayton, E., Fahey, M., Ashworth, M., Besser, S. J., Weinman, J., & Wright, A. J. (2017). Psychological 
Determinants of Medication Adherence in Stroke Survivors: a Systematic Review of Observational Studies. Annals 
of behavioral medicine : a publication of the Society of Behavioral Medicine, 51(6), 833–845.  

 
2. Research Objectives  
1. To investigate the problems and self - care needs of elderly COPD patients with 
MCI in using home oxygen concentrators.  
2. To apply the BCW theory model to construct a health education model and 
explore its application effect in improving the self - management ability and 
compliance of elderly patients with MCI and COPD during long - term oxygen 
therapy with home oxygen concentrators.  
3. Research Method  
  
3.1 Object of Study  
1. Source of the study subjects and the sampling methods: The study subjects 
will be selected from the respiratory department of a tertiary hospital in 
Xiamen,  
Fujian Province, and a community health service center in Tong'an District,  
Xiamen. The sampling method is convenience sampling.  
2. Inclusion criteria for the study subjects: o  Diagnosed as COPD by a 
physician. o  SpO2 < 88% or PaO2 < 60mmHg.  
o Diagnosed with MCI. o  Have a home oxygen concentrator.  
o No communication barriers.  
3. Exclusion criteria for the study subject:  
o Complicated with asthma or lung cancer.  
o Long - term home oxygen therapy time ≥ 15h/d.  
o Participated in similar interventions.  
4. Samplesize estimation: The sample size is calculated using the formula for 
comparing two - sample rates. Referring to the literature, the oxygen therapy 
compliance rate is 20%, and it is expected to increase by 40% after 
intervention. With a significance level of 0.05 and a Type II error probability 
of 0.1, 32 cases are required for each of the intervention group and the control 
group. Considering a 20% dropout rate, the final sample size is determined to 
be 39 cases per group, with a total of 78 cases.  

 
3.2 Research Tool  
（1） The execution of LTHOT was assessed using a self-designed Long-Term 
Home Oxygen Therapy Behavior Survey. Given that improper operational skills can 
affect the effectiveness of long-term home oxygen therapy, the survey primarily 
includes four dimensions: adherence to home oxygen therapy, cleaning and disinfection, 
safe oxygen use, and self-monitoring, with a total of 13 items. Each item has two 
response options: "Yes" and "No," where "Yes" indicates the behavior was performed, 
and "No" indicates it was not. A score of 1 is awarded for "Yes," and 0 for "No." The 
higher the total score, the better the patient's long-term home oxygen therapy behavior. 
The average daily oxygen use time was self-reported by the patient.  
（2） LTHOT Health Belief was assessed using the Long-Term Home Oxygen 
Therapy Health Belief Questionnaire designed by Yan, J 15. The questionnaire consists 
of four dimensions and 26 items. Scores are based on the individual's understanding of 
their ability to engage in long-term home oxygen therapy behaviors. The total score 
ranges from 0 to 104, with higher scores indicating a higher level of perceived ability 
to perform long-term home oxygen therapy health behaviors.  
（3） Activity of Daily Living (ADL): Daily living ability was assessed using 
the Activity of Daily Living scale16, with a total score range of 14-56 points. A higher 
score indicates poorer functional ability. A total score greater than 16 points indicates 
varying degrees of functional impairment, while a score of 22 points or higher indicates 
significant functional impairment. If the score for any single item exceeds 3 points, or 
if two or more items score over 3 points, this suggests significant functional impairment.  
（4） Ventilation Function Indicators: These include blood oxygen saturation 
(SpO2), arterial carbon dioxide partial pressure (PaCO2), arterial oxygen partial 
 
15 Yan, J., Zhang, E., & Yu, L. (2017). The effect of health belief model-based intervention on long-term home 
oxygen therapy behavior in patients with chronic obstructive pulmonary disease. Chinese Journal of Medical 
Guide, 14(17), 165-169.  
16 Lawton, M.P., Brody, E.M., 1969. Assessment of older people: self-maintaining and instrumental activities of daily 
living. Gerontologist 9, 179–186.  

 
pressure (PaO2), pH, lung function (FEV1%), dyspnea score, and 6-minute walk 
distance (6MWD).  
（5） Overall cognitive function The Montreal Cognitive Assessment (MoCA) 
is used to measure overall cognitive function17, with a maximum score of 30. The cutoff 
scores for normal cognitive function are >13 for illiterate individuals, >19 for those 
with primary education, and >24 for individuals with middle school education or higher.  
  
3.3 Data Processing and Statistical Analysis  
1. After the data collection is completed, SPSS 20.0 software is used for statistical  
  
analysis.  
2. The description of general demographic data and clinical data: Count data are 
described by frequency and percentage; measurement data are described by 
median.  
3. Comparison of general demographic data and clinical data between the two 
groups of research subjects: Rank - sum test and X² test are used.  
4. Comparison of the total scores of long - term home oxygen therapy beliefs at 
each time point between the two groups of research subjects: Repeated - 
measures analysis of variance is used.  
5. Comparison of the scores of each dimension of long - term home oxygen therapy 
beliefs, long - term home oxygen therapy behavior scores, and average daily 
oxygen inhalation time at each time point between the two groups of research 
subjects: Generalized linear mixed - effect model is used for analysis.  
6. Comparison between groups of the total scores and scores of each dimension of 
long - term home oxygen therapy beliefs, long - term home oxygen therapy 
behavior scores, and average daily oxygen inhalation time at different time 
points of the two groups of research subjects: If it conforms to the normal 
 
17 Tu, Q., Jin, H., Ding, B., Yang, X., Lei, Z., Bai, S., Zhang, Y., Tang, X., 2013. Reliability, validity, and optimal 
cutoff score of the Montreal Cognitive Assessment (Changsha version) in ischemic cerebrovascular disease patients 
of Hunan Province, China. Dement Geriatr Cogn Dis Extra 3, 25–36.  

 
distribution, an independent - sample t - test is used; if it does not conform to 
the normal distribution, a two - independent - sample rank - sum test is used.  
7. Comparison within groups of the total scores and scores of each dimension of 
long - term home oxygen therapy beliefs, long - term home oxygen therapy 
behavior scores, and average daily oxygen inhalation time at different time 
points of the two groups of research subjects: If it conforms to the normal 
distribution, a paired t - test is used; if it does not conform to the normal 
distribution, a paired rank - sum test is used.  
8. Comparison of the differences in the scores of the Montreal Cognitive 
Assessment Scale, Mini - Mental State Examination, Geriatric Depression Scale, 
and Self - rating Anxiety Scale between the intervention group and the control 
group: An independent - sample t - test is used.  
3.4 The Project Involves the Implementation Plan of the Ethical Par  
  
  
1. Voluntary Principle: Ensure informed consent. Before participating in the 
study, patients are informed of the purpose, content, and procedures of the study. 
Patients can freely withdraw from the study during the process, and their 
relevant rights will not be damaged.  
2. Confidentiality Principle: Seek the opinions of patients on the confidentiality 
of the research content according to the research questions. Adhere to the 
confidentiality principle for issues involving participants' privacy and personal 
safety.  
3. Beneficence and Non - maleficence Principle: This study has no potential 
harm to the physical and mental health of patients. On the contrary, the 
intervention may be beneficial to the implementation of long - term home 
oxygen therapy and treatment outcomes of patients.  

 
4. Justice Principle: Treat all research subjects equally. Whether in the control 
group or the intervention group, strictly follow the research design plan to 
conduct the research rigorously and fairly.