Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Geriatrics
Published in: BMC Geriatrics 1/2021

Open Access 01-12-2021 | Study protocol

A community-based nurse-led medication self-management intervention in the improvement of medication adherence in older patients with multimorbidity: protocol for a randomised controlled trial

Authors: Chen Yang, Zhaozhao Hui, Dejian Zeng, Song Zhu, Xiuhua Wang, Diana Tze Fan Lee, Sek Ying Chair

Published in: BMC Geriatrics | Issue 1/2021

Login to get access

Abstract

Background

Older patients suffering from multimorbidity are at high risk of medication nonadherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. However, little is known about the effect of the medication self-management intervention in older patients with multimorbidity. This paper presents the protocol for a study that aims to evaluate the effectiveness of a nurse-led medication self-management intervention in improving medication adherence and health outcomes for community-dwelling older patients with multimorbidity.

Methods

The study protocol follows the recommendations of the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This study is a multicentre, single-blind, two-arm randomised controlled trial. Older patients with multimorbidity will be recruited from three community health centres in Changsha, China. A total of 136 participants will be randomly allocated to receive usual care or usual care plus the medication self-management intervention. The intervention will be delivered by community nurses. The 6-week intervention includes three face-to-face education sessions and two weekly follow-up phone calls. Participants in the control group continue to receive all respects of usual care offered by community healthcare providers, including chronic disease management, drug prescription, referral to hospital specialists, health education and consultations regarding patients’ diseases and treatments during centre visits. The primary outcome is medication adherence as measured by the 5-item Medication Adherence Report Scale. Secondary outcomes include medication self-management capacity (medication knowledge, medication beliefs, medication social support, medication skills, and medication self-efficacy), treatment experiences (medication treatment satisfaction and treatment burden), quality of life, and utilisation of healthcare services. All outcomes will be measured at baseline, immediately post-intervention, and at 3-month post-intervention.

Discussion

This study will provide evidence about the effectiveness of a medication self-management intervention, delivered by nurses, for older patients with multimorbidity and adherence problems. It is expected that the results of the study, if proven effective in improving patients’ adherence and health outcomes, will provide evidence-based self-management support strategies for healthcare providers in routine chronic disease management in community settings.

Trial registration

The trial is registered at ChiCTR.​org.​cn (ChiCTR2000030011​; date February 19, 2020).
Appendix
Available only for authorised users
Literature
1.
2.
Walsh CA, Cahir C, Tecklenborg S, Byrne C, Culbertson MA, Bennett KE. The association between medication non-adherence and adverse health outcomes in ageing populations: a systematic review and meta-analysis. Br J Clin Pharmacol. 2019;85:2464–78.PubMedPubMedCentralCrossRef
3.
Khayyat SM, Mohamed MMA, Khayyat SMS, Hyat Alhazmi RS, Korani MF, Allugmani EB, et al. Association between medication adherence and quality of life of patients with diabetes and hypertension attending primary care clinics: a cross-sectional survey. Qual Life Res. 2019;28:1053–61.PubMedCrossRef
4.
Aznar-Lou I, Fernández A, Gil-Girbau M, Sabés-Figuera R, Fajó-Pascual M, Peñarrubia-María MT, et al. Impact of initial medication non-adherence on use of healthcare services and sick leave: a longitudinal study in a large primary care cohort in Spain. Br J Gen Pract. 2017;67:e614–22.PubMedPubMedCentralCrossRef
5.
Marengoni A, Angleman S, Melis R, Mangialasche F, Karp A, Garmen A, et al. Aging with multimorbidity: a systematic review of the literature. Ageing Res Rev. 2011;10:430–9.PubMedCrossRef
6.
Wimmer BC, Cross AJ, Jokanovic N, Wiese MD, George J, Johnell K, et al. Clinical outcomes associated with medication regimen complexity in older people: a systematic review. J Am Geriatr Soc. 2017;65:747–53.PubMedCrossRef
7.
Calderón-Larrañaga A, Poblador-Plou B, González-Rubio F, Gimeno-Feliu LA, Abad-Díez JM, Prados-Torres A. Multimorbidity, polypharmacy, referrals, and adverse drug events: are we doing things well? Br J Gen Pract. 2012;62:e821–6.PubMedPubMedCentralCrossRef
8.
Eton DT, Ramalho de Oliveira D, Egginton JS, Ridgeway JL, Odell L, May CR, et al. Building a measurement framework of burden of treatment in complex patients with chronic conditions: a qualitative study. Patient Relat Outcome Meas. 2012;3:39–49.PubMedPubMedCentralCrossRef
9.
Van Merode T, Van De Ven K, Van Den Akker M. Patients with multimorbidity and their treatment burden in different daily life domains: a qualitative study in primary care in the Netherlands and Belgium. J Comorbidity. 2018;8:9–15.
10.
Rosbach M, Andersen JS. Patient-experienced burden of treatment in patients with multimorbidity - a systematic review of qualitative data. PLoS One. 2017;12:e0179916.PubMedPubMedCentralCrossRef
11.
Wong MCS, Liu J, Zhou S, Li S, Su X, Wang HHX, et al. The association between multimorbidity and poor adherence with cardiovascular medications. Int J Cardiol. 2014;177:477–82.PubMedCrossRef
12.
Smaje A, Weston-Clark M, Raj R, Orlu M, Davis D, Rawle M. Factors associated with medication adherence in older patients: a systematic review. Aging Med. 2018;1:254–66.CrossRef
13.
14.
Marcum ZA, Hanlon JT, Murray MD. Improving medication adherence and health outcomes in older adults: an evidence-based review of randomized controlled trials. Drugs Aging. 2017;34:191–201.PubMedPubMedCentralCrossRef
15.
Viswanathan M, Golin CE, Jones CD, Ashok M, Blalock SJ, Wines RCM, et al. Interventions to improve adherence to self-administered medications for chronic diseases in the United States: a systematic review. Ann Intern Med. 2012;157:785–95.PubMedCrossRef
16.
17.
Williams A, Manias E, Walker R. Interventions to improve medication adherence in people with multiple chronic conditions: a systematic review. J Adv Nurs. 2008;63:132–43.PubMedCrossRef
18.
Reed RL, Roeger L, Howard S, Oliver-Baxter JM, Battersby MW, Bond M, et al. A self-management support program for older Australians with multiple chronic conditions: a randomised controlled trial. Med J Aust. 2018;208:69–74.PubMedCrossRef
19.
Barley EA, Walters P, Haddad M, Phillips R, Achilla E, McCrone P, et al. The UPBEAT nurse-delivered personalized care intervention for people with coronary heart disease who report current chest pain and depression: a randomised controlled pilot study. PLoS One. 2014;9:e98704.PubMedPubMedCentralCrossRef
20.
Bogner HR, de Vries HF. Integrating type 2 diabetes mellitus and depression treatment among African-Americans: a randomized controlled pilot trial. Diabetes Educ. 2010;36:284–92.PubMedCrossRef
21.
Boult C, Leff B, Boyd CM, Wolff JL, Marsteller JA, Frick KD, et al. A matched-pair cluster-randomized trial of guided care for high-risk older patients. J Gen Intern Med. 2013;28:612–21.PubMedPubMedCentralCrossRef
22.
Smith S, Wallace E, O’Dowd T, Fortin M. Interventions for improving outcomes in patients with multimorbidity in primary care and community settings. Cochrane Database Syst Rev. 2016;3:CD006560.PubMed
23.
Wilhelmsen NC, Eriksson T. Medication adherence interventions and outcomes: an overview of systematic reviews. Eur J Hosp Pharm. 2019;26:187–92.PubMedCrossRef
24.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.PubMedPubMedCentralCrossRef
25.
Schulz KF, Altman DG, Moher D, the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18.PubMedPubMedCentralCrossRef
26.
27.
Yang C, Hui Z, Zeng D, Liu L, Lee DTF. Examining and adapting the information–motivation–behavioural skills model of medication adherence among community-dwelling older patients with multimorbidity: protocol for a cross-sectional study. BMJ Open. 2020;10:e033431.PubMedPubMedCentralCrossRef
28.
Yang C, Hui Z, Zeng D, Liu L, Zhu S, Lee DTF. Predictors of medication adherence among community-dwelling older patients with multimorbidity: validation and adaptation of the information-motivation-behavioral skills model. J Am Geriatr Soc. 2020;68:S138.
29.
Wang HHX, Wang JJ, Wong SYS, Wong MCS, Mercer SW, Griffiths SM. The development of urban community health centres for strengthening primary care in China: a systematic literature review. Br Med Bull. 2015;116:139–54.PubMed
30.
Fortin M, Stewart M, Poitras ME, Almirall J, Maddocks H. A systematic review of prevalence studies on multimorbidity: toward a more uniform methodology. Ann Fam Med. 2012;10:142–51.PubMedPubMedCentralCrossRef
31.
Horne R, Weinman J. Self-regulation and self-management in asthma: exploring the role of illness perceptions and treatment beliefs in explaining non-adherence to preventer medication. Psychol Health. 2002;17:17–32.CrossRef
32.
Faul F, Erdfelder E, Lang AG, Buchner A. G*power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39:175–91.PubMedCrossRef
33.
Krska J, Cromarty JA, Arris F, Jamieson D, Hansford D, Duffus PRS, et al. Pharmacist-led medication review in patients over 65: a randomized, controlled trial in primary care. Age Ageing. 2001;30:205–11.PubMedCrossRef
34.
Miller WR, Rollnick S. Motivational interviewing: helping people change. 3rd ed. New York: Guilford Press; 2013.
35.
Wei L, Champman S, Li X, Li X, Li S, Chen R, et al. Beliefs about medicines and non-adherence in patients with stroke, diabetes mellitus and rheumatoid arthritis: a cross-sectional study in China. BMJ Open. 2017;7:e017293.PubMedPubMedCentralCrossRef
36.
Chan AHY, Horne R, Hankins M, Chisari C. The medication adherence report scale: a measurement tool for eliciting patients’ reports of nonadherence. Br J Clin Pharmacol. 2020;86:1281–8.PubMedPubMedCentralCrossRef
37.
Lin CY, Ou HT, Nikoobakht M, Broström A, Årestedt K, Pakpour AH. Validation of the 5-item medication adherence report scale in older stroke patients in Iran. J Cardiovasc Nurs. 2018;33:536–43.PubMedCrossRef
38.
Scribano ML, Caprioli F, Michielan A, Contaldo A, Privitera AC, Bozzi RM, et al. Translation and initial validation of the medication adherence report scale (MARS) in Italian patients with Crohn’s disease. Dig Liver Dis. 2019;51:640–7.CrossRef
39.
Inauen J, Bierbauer W, Lüscher J, König C, Tobias R, Ihle A, et al. Assessing adherence to multiple medications and in daily life among patients with multimorbidity. Psychol Health. 2017;32:1233–48.PubMedCrossRef
40.
Zou D, Liang B, Li J. The related factors of medication adherence in patients undergoing continuous ambulatory peritoneal dialysis. Chinese J Integr Tradit West Nephrol. 2017;18:723–6.
41.
Ruksakulpiwat S, Liu Z, Yue S, Fan Y. The association among medication beliefs, perception of illness and medication adherence in ischemic stroke patients: a cross-sectional study in China. Patient Prefer Adherence. 2020;14:235–47.PubMedPubMedCentralCrossRef
42.
Okere AN, Renier CM, Morse J. Development and validation of a survey to assess patient-perceived medication knowledge and confidence in medication use. J Nurs Meas. 2014;22:120–34.PubMedCrossRef
43.
44.
Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health. 1999;14:1–24.CrossRef
45.
Wu M, Hu Y, Zhu Y, Huang J. Evaluation of the Chinese version of the beliefs and medicines questionnaire in patients with breast cancer receiving hormonal therapy. J Nurs Sci. 2014;29:31–3.
46.
Lehavot K, Huh D, Walters KL, King KM, Andrasik MP, Simoni JM. Buffering effects of general and medication-specific social support on the association between substance use and HIV medication adherence. AIDS Patient Care STDs. 2011;25:181–9.PubMedPubMedCentralCrossRef
47.
Risser J, Jacobson TA, Kripalani S. Development and psychometric evaluation of the self-efficacy for appropriate medication use scale (SEAMS) in low-literacy patients with chronic disease. J Nurs Meas. 2007;15:203–19.PubMedCrossRef
48.
Dong X, Liu Y, Wang A, Wang M. Psychometric properties of the Chinese version of the self-efficacy for appropriate medication use scale in patients with stroke. Patient Prefer Adherence. 2016;10:321–7.
49.
Atkinson MJ, Kumar R, Cappelleri JC, Hass SL. Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers. Value Heal. 2005;8:S9–S24.CrossRef
50.
Tran VT, Harrington M, Montori VM, Barnes C, Wicks P, Ravaud P. Adaptation and validation of the treatment burden questionnaire (TBQ) in English using an internet platform. BMC Med. 2014;12:109.PubMedPubMedCentralCrossRef
51.
Tran VT, Montori VM, Eton DT, Baruch D, Falissard B, Ravaud P. Development and description of measurement properties of an instrument to assess treatment burden among patients with multiple chronic conditions. BMC Med. 2012;10:68.PubMedPubMedCentralCrossRef
52.
Pender K, Omole O. Blood pressure control and burden of treatment in south African primary healthcare: a cross-sectional study. African J Prim Heal Care Fam Med. 2019;11:a2110.
53.
Chin WY, Wong CKH, Ng CCW, Choi EPH, Lam CLK. Cultural adaptation and psychometric properties of the Chinese burden of treatment questionnaire (C-TBQ) in primary care patients with multi-morbidity. Fam Pract. 2019;36:657–65.
54.
55.
Luo N, Liu G, Li M, Guan H, Jin X, Rand-Hendriksen K. Estimating an EQ-5D-5L value set for China. Value Heal. 2017;20:662–9.CrossRef
56.
Xing Y, Ma A. Study on reliability and validity of Chinese version of EQ-5D-5L. Shanghai Med Pharm J. 2013;9:40–3.
57.
Miller MD, Paradis CF, Houck PR, Mazumdar S, Stack JA, Rifai AH, et al. Rating chronic medical illness burden in geropsychiatric practice and research: application of the cumulative illness rating scale. Psychiatry Res. 1992;41:237–48.PubMedCrossRef
58.
Salvi F, Miller MD, Grilli A, Giorgi R, Towers AL, Morichi V, et al. A manual of guidelines to score the modified cumulative illness rating scale and its validation in acute hospitalized elderly patients. J Am Geriatr Soc. 2008;56:1926–31.PubMedCrossRef
59.
60.
Chen X, Yan J, Wang J, Yu P, Geriatric, Gerontology Branch of Chinese Medicine Association. Chinese expert consensus on the application of comprehensive geriatric assessment for the elderly. Aging Med. 2018;1:100–5.CrossRef
61.
62.
Levis B, Benedetti A, Thombs BD. Accuracy of patient health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis. BMJ. 2019;365:l1476.PubMedPubMedCentralCrossRef
63.
Wang W, Bian Q, Zhao Y, Li X, Wang W, Du J, et al. Reliability and validity of the Chinese version of the patient health questionnaire (PHQ-9) in the general population. Gen Hosp Psychiatry. 2014;36:539–44.PubMedCrossRef
64.
Moyers TB, Manuel JK, Ernst D. Motivational Interviewing Treatment Integrity Coding Manual 4.1. Unpublished Manual. 2014.
65.
Keogh-Brown MR, Bachmann MO, Shepstone L, Hewitt C, Howe A, Ramsay CR, et al. Contamination in trials of educational interventions. Health Technol Assess. 2007;11:iii, ix–107.CrossRef
66.
Costa E, Pecorelli S, Giardini A, Savin M, Menditto E, Lehane E, et al. Interventional tools to improve medication adherence: review of literature. Patient Prefer Adherence. 2015;9:1303–14.PubMedPubMedCentralCrossRef
67.
Cross A, Elliott R, Petrie K, Kuruvilla L, George J. Interventions for improving medication-taking ability and adherence in older adults prescribed multiple medications. Cochrane Database Syst Rev. 2020;5:CD012419.PubMed
68.
Dineen-Griffin S, Garcia-Cardenas V, Williams K, Benrimoj SI. Helping patients help themselves: a systematic review of self-management support strategies in primary health care practice. PLoS One. 2019;14:e0220116.PubMedPubMedCentralCrossRef
69.
70.
American Geriatrics Society Expert Panel on the Care of Older Adults with Multimorbidity. Patient-centered care for older adults with multiple chronic conditions: a stepwise approach from the American Geriatrics Society. J Am Geriatr Soc. 2012;60:1957–68.PubMedCentralCrossRef
71.
Sav A, King MA, Whitty JA, Kendall E, Mcmillan SS, Kelly F, et al. Burden of treatment for chronic illness: a concept analysis and review of the literature. Health Expect. 2015;18:312–24.PubMedCrossRef
72.
Laurant M, van der Biezen M, Wijers N, Watananirun K, Kontopantelis E, van Vught AJAH. Nurses as substitutes for doctors in primary care. Cochrane Database Syst Rev. 2018;7:CD001271.PubMed
73.
Verloo H, Chiolero A, Kiszio B, Kampel T, Santschi V. Nurse interventions to improve medication adherence among discharged older adults: a systematic review. Age Ageing. 2017;46:747–54.PubMedCrossRef
74.
Van Camp YP, Van Rompaey B, Elseviers MM. Nurse-led interventions to enhance adherence to chronic medication: systematic review and meta-analysis of randomised controlled trials. Eur J Clin Pharmacol. 2013;69:761–70.PubMedCrossRef
Metadata
Title
A community-based nurse-led medication self-management intervention in the improvement of medication adherence in older patients with multimorbidity: protocol for a randomised controlled trial
Authors
Chen Yang
Zhaozhao Hui
Dejian Zeng
Song Zhu
Xiuhua Wang
Diana Tze Fan Lee
Sek Ying Chair
Publication date
01-12-2021
Publisher
BioMed Central
Published in
BMC Geriatrics / Issue 1/2021
Electronic ISSN: 1471-2318
DOI
https://doi.org/10.1186/s12877-021-02097-x

Other articles of this Issue 1/2021

BMC Geriatrics 1/2021 Go to the issue

Research article

Reducing the use of physical restraints in home care: development and feasibility testing of a multicomponent program to support the implementation of a guideline

Research

Effects of an interprofessional deprescribing intervention in Swiss nursing homes: the Individual Deprescribing Intervention (IDeI) randomised controlled trial

Research article

Pain assessment and management in care homes: understanding the context through a scoping review

Research article

Association between successful aging transitions and depressive symptoms among older Korean adults: findings from the Korean longitudinal study of aging (2006–2018)

Research

Mechanisms of impact and contextual aspects of a dementia special care unit in long-term care: a process evaluation

Research article

End-stage knee osteoarthritis with and without sarcopenia and the effect of knee arthroplasty – a prospective cohort study

ACC 2024 Congress Coverage

Heart Failure Video

Year in Review: Heart failure and cardiomyopathies

Watch now

Watch this official video from ACC.24. Dr. Biykem Bozkurt discuss last year's major advances in heart failure and cardiomyopathies.

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

16-04-2024 Type 2 Diabetes News

Incentivised to exercise

11-04-2024 Lifestyle Modifications News

New intervention for STEMI-related cardiogenic shock

10-04-2024 Myocardial Infarction News

» View more highlights on the ACC 2024 congress hub page

Image Credits