Research Project
Received: 24 November 2018 | Revised: 8 March 2019 | Accepted: 10 March 2019
DOI: 10.1111/ppc.12376
OR I G I NA L AR T I C L E
Randomized controlled trial of the effects of nursing care based on a telephone intervention for medication adherence in schizophrenia
Esra Uslu PhD, RN1 | Kadriye Buldukoglu PhD, RN2
1Department of Psychiatric Mental Health
Nursing, Faculty of Health Science, Eskisehir
Osmangazi University, Eskisehir, Turkey
2Department of Psychiatric Mental Health
Nursing, Faculty of Nursing, Akdeniz
University, Antalya, Turkey
Correspondence
Esra Uslu, PhD, RN, Department of Psychiatric
Mental Health Nursing, Faculty of Health
Science, Eskisehir Osmangazi University,
26480 Eskisehir, Turkey.
Email: esra.uslu@ogu.edu.tr
Abstract
Purpose: Our aim was to determine the effects of “Telephone Intervention Problem
Solving” (TIPS) on medication adherence among individuals diagnosed with schizo-
phrenia.
Design and Methods: This randomized controlled trial was conducted with
45 patients. TIPS was applied to the intervention group for 2 months, whereas the
control group received routine care.
Findings: We found that the rate of voluntary continuation of medicine (P < 0.001),
belief in the necessity of medication (P = 0.008) and medication adherence scores
were higher in the intervention group (P < 0.001).
Practical Implications: This study may serve as a guide for applying telephone
communication to clinical interventions in psychiatric nursing.
K E YWORD S
medication adherence, problem solving, schizophrenia, telenursing, telephone
1 | INTRODUCTION
Medication is an effective option for the treatment of schizophrenia.1
However, despite the supportive aspects of medication, most
patients with schizophrenia are reluctant to take antipsychotic
drugs.2 Some resources report that at least half of the patients with
schizophrenia face medication adherence problems,3–5 whereas
some resources report that approximately 80% of patients with
schizophrenia face these issues.6 According to a study implemented
in Turkey, the nonadherence rate is 85%.7 The side effects of
psychiatric drugs,8–10 negative attitudes toward medication,11
distrust toward medication, a history of quitting medication will-
ingly,12,13 psychiatric symptoms, memory problems,14 substance or
alcohol abuse accompanying the disease,14,15 and insufficient social
support16 are the risk factors for medication adherence problems.
Medication adherence problems can lead to harmful effects in many
areas,17 including relapse of the disease,18 increased utilization of
health facilities, patient hospitalization and associated costs,19
deterioration in the general health condition of a patient, a decreased
response to treatment,11,20 and suicide attempts.18 On the basis of
this information, the medication adherence problems of patients with
schizophrenia need to be solved.21
Patients with schizophrenia need effective, accessible, and
affordable interventions for their medication adherence pro-
blems.14 Currently, periodic telephone interviews are considered
a cost‐effective option for encouraging patients to participate in
their treatment.22 These interviews also create a bridge between
the patient and the care professional.23,24 Conversely, patients
with schizophrenia attract less attention in terms of receiving care
with telemedicine technologies.23,25 However, the care provided
to patients with schizophrenia over the telephone has been found
to extend the time that patients spend in society and to reduce the
number of days spent in the hospital during repeat hospitaliza-
tions, as well as the number of applications for rehospitalization.26
This approach has also been observed to increase psychiatric
medication adherence after discharge11,27–29 and to decrease the
severity of psychiatric symptoms.11,29 Despite the encouraging
Perspect Psychiatr Care. 2020;56:63-71. wileyonlinelibrary.com/journal/ppc © 2019 Wiley Periodicals, Inc. | 63
This study was presented as a oral presentation in V. International, National Psychiatric
Nursing Congress and awarded to best oral presentation second prize.
effects of telephone‐based interventions, the literature empha-
sizes the limitations of relevant experimental studies.11,14,23,25,30
Thus, this study will provide an evidence‐based contribution to the
literature.
In this study, a telephone‐based application was implemented
using “Telephone Intervention Problem Solving (TIPS).”
1.1 | Telephone Intervention Problem Solving
Developed by Beebe and grounded in a planned behavior theory,
TIPS is a telenursing application.11 This application supports
solutions for various daily life problems among patients with
schizophrenia and offers coping alternatives for these problems.
This program also reminds patients to utilize these alternatives and
evaluates their efficiency.27,31 TIPS is conducted with weekly
telephone interviews. This intervention is applied by planning an
interview with a patient on a certain day at a specific hour. The
intervention is initiated by a nurse who implements TIPS using the
corresponding manual for guidance. The content of each interview
consists of topics regarding problems among patients with schizo-
phrenia (Table 1). Additionally, this intervention has been described
in detail elsewhere: https://nursing.utk.edu/wp‐content/uploads/ sites/36/2018/08/APPATIPSman.pdf
1.2 | The theoretical basis of TIPS
Planned behavior theory includes the concepts of attitude,
subjective norms, and perceived behavior control.32 TIPS touches
on all these concepts. Attitude reflects the perceived beliefs and
values concerning medication adherence. Subjective norms reflect
the extent to which families or caregivers encourage medication
adherence. Perceived behavior control reflects the ease or
difficulty of overcoming obstacles and a person's trust in their
ability to do so. Thus, with the help of TIPS, nurses provide
information (attitude) to patients regarding the benefits of
medication adherence, discuss the value of medication adherence,
and strengthen patients' resolve (subjective norm) in addition to
solving problems related to medication adherence (perceived
behavior control).11,14
2 | METHODS
2.1 | Aim and hypotheses
This study aimed to determine the effect of TIPS on medication
adherence in individuals diagnosed with schizophrenia. According to
this aim, the following hypotheses were tested:
1. The rate of discontinuing medication willingly is lower in patients
with schizophrenia who participate in TIPS than that in patients
who do not participate in TIPS.
2. The rate of believing in the necessity of medication is higher in
patients with schizophrenia who participate in TIPS than that in
patients who do not participate in TIPS.
3. The rate of medication adherence is higher in patients with
schizophrenia who participate in TIPS than that in patients who
do not participate in TIPS.
2.2 | Design
The study was implemented as a prospective, randomized controlled
trial using a pretest and posttest design. Figure 1 shows the
CONSORT flow diagram of this study.
2.3 | Participants
The study included patients who were hospitalized in a university
hospital and diagnosed with schizophrenia. The inclusion criteria
were as follows: (i) sufficient cognitive competence to participate
in the study willingly, (ii) access to a fixed telephone, and (iii)
competence in speaking Turkish. The exclusion criteria were as
follows: (i) the presence of a different psychiatric diagnosis
accompanying schizophrenia, (ii) despite the advice of a doctor
refuse treatment and leave the clinic, (iii) hearing loss impeding
communication via telephone, and (iv) substance abuse. The removal
criteria were as follows: (i) a desire to withdraw willingly at any stage
of the study and (ii) lack of participation in three successive
telephone interviews.
2.4 | Sample size
The initial power of the study was determined to be 80%, and the
type 1 error rate was 5%. The effect size was calculated using a
method from a similar study, which utilized the Medication
Adherence Rating Scale (MARS).33 Accordingly, a minimal differ-
ence of 1 point in dual comparisons determined according to the
MARS was projected to signify a clinically significant difference,
and the initial effect size was calculated to be d = 0.64.
In accordance with the hypotheses for the study, a sample of
at least 31 individuals was determined to be required; therefore, a
TABLE 1 Weekly Telephone Intervention Problem Solving (TIPS) call topics
Topics
1. Are you taking your medication as prescribed? Have you missed any
doses at all?
2. Do you know when your next appointment is scheduled?
3. Have you had any (symptoms) since we last talked? (symptoms
specific to each participant were collected at baseline.)
4. Have you had any cravings for alcohol or other drugs this week that
you have found uncomfortable?
5. How have you been getting along with others this week?
6. Do you have any questions about anything this week?
7. Is there anything else that you would like to talk about today?
64 | USLU AND BULDUKOGLU
total of 62 individuals were required for the study. Following a
data collection process that had taken 1 year (intervention group,
n = 21 and control group, n = 24), the power analysis was
performed again, and the effect size was calculated. The effect
size was d = 2.86, and the study power was 100%. The data
collection process was terminated due to cost and time con-
straints.
2.4.1 | Randomization and blinding
The participants were randomly assigned to the intervention and
control groups using a simple randomization method. The
researcher prepared 62 envelopes. The envelopes were selected
by lot, and the patients were assigned to the intervention and
control groups. The investigator delivered the intervention and
therefore could not be blinded to the allocation. The individuals
assigned to the intervention and control groups were examined to
identify differences between them in terms of factors affecting
medication adherence (Table 2).
2.5 | Intervention
To conduct TIPS efficiently and preserve the homogeneity between
the groups, “Medication Adherence Training (MAT)”, including
medication information and solutions to medication side effects,
was provided to all participants. MAT was provided individually
F IGURE 1 CONSORT flowchart of the study. GAI, Global Assessment of Functioning Scale; MARS, Medication Adherence Rating Scale; SAI, Schedule for Assessing the Three Components of Insight
USLU AND BULDUKOGLU | 65
according to the wishes of the clinic employees and patients at the
best time for each patient. MAT was provided for 20 minutes per
day over 2 successive days. The program was completed before a
patient's discharge.
2.5.1 | Intervention group
The participants were informed of the TIPS program after MAT,
and a certain day and hour for TIPS were planned with the patient
before discharged. After discharge, first TIPS was applied on the
day and hour planned by a patient. TIPS was applied by the
researcher once a week for a total of eight times over 2 months.
The “TIPS Manual” was used during the calls. The data acquired
during TIPS were written down during every telephone interview.
Meanwhile, routine clinical care continued.
2.5.2 | Control group
The patients in the control group received routine care provided by
the hospital.
2.6 | Data collection
Data were collected during the period of February 2016 to February
2017. Both groups completed a personal information form and
TABLE 2 Comparison of factors affecting medication adherence between groups (n = 46)
Factors affecting medication adherence (n = 46) Intervention group (n = 22), n (%) Control group (n = 24), n (%) χ2 P
Gender 0.003 0.958
Female 13 (59.1) 14 (58.3)
Male 9 (58.3) 10 (41.7)
Age 248.0+ 0.725
Median (min‐max) 36 (22‐82) 39.5 (20‐68)
Marital status 1.322 0.250
Married 9 (40.9) 6 (25)
Single 13 (59.1) 18 (75)
Economic condition perception
Good 5 (22.7) 4 (16.7) – NA
Medium 15 (68.2) 12 (50)
Bad 2 (9.1) 8 (33.3)
People live with you 0.004 0.999
Yes 21 (95.5) 23 (95.8)
No 1 (4.5) 1 (4.2)
People support your life
Yes 21 (95.5) 23 (95.8) 0.004 0.999
No 1 (4.5) 1 (4.2)
Belief in the necessity of medication
Yes 13 (59.1) 16 (66.7) 0.283 0.595
No 9 (40.9) 8 (33.3)
History of psychiatric drug use
Yes 22 (100) 24 (100) – –
No 0 0
Voluntary discontinuation of medicine
Yes 22 (100) 24 (100) – –
No 0 0
Years since schizophrenia diagnosis, median (min‐max) 4 (1‐25) 10 (1‐35) 185.5a 0.083
SAI, median (min‐max) 10.5 (0‐18) 9 (1‐15) 209a 0.224
GAF, median (min‐max) 70 (40‐81) 63.5 (45‐78) 190.5a 0.105
MARS, median (min‐max) 4 (3‐6) 5 (1‐8) 207a 0.201
Abbreviations: GAI, Global Assessment of Functioning Scale; MARS, Medication Adherence Rating Scale; max, maximum; min, minimum; NA, not applied;
SAI, Schedule for Assessing the Three Components of Insight. aThe Mann‐Whitney U test.
66 | USLU AND BULDUKOGLU
pretest measures before MAT. At the end of the intervention (after
applying eight TIPS), both groups completed a final evaluation form
and posttest measure.
2.7 | Outcome measures
2.7.1 | Personal information form
This form was part of the pretest material. The form was prepared by
the researcher according to the previous literature5,31 and consists of
12 questions. The questions focus on demographic characteristics
that may affect medication adherence and drug use characteristics.
2.7.2 | Schedule for Assessing the Three Components of Insight
This form was part of the pretest material. In the Turkish validity and
reliability study of this schedule for evaluating insight quantitatively,
the Cronbach α coefficient was found to be 0.808,34 whereas, in this
study, the Cronbach α reliability coefficient was found to be 0.91. The
schedule has a total of eight questions. The highest possible score is
18. A higher score for a patient indicates that she or he has a higher
level of insight.
2.7.3 | The Global Assessment of Functioning Scale
This scale was part of the pretest material and was used to assess the
psychological, social, and occupational functioning of the participants.
The single‐item Global Assessment of Functioning Scale (GAF) is
scored from 0 to 100, and a higher score indicates better
psychosocial functioning.
2.7.4 | Medication Adherence Rating Scale
This scale was part of the pretest and posttest materials. In the
Turkish validity and reliability study of this scale for evaluating
medication adherence, the Kuder‐Richardson 20 reliability
coefficient was 0.92,35 whereas, in this study, the coefficient
was 0.817. The scale is a 10‐item yes/no self‐report instrument.
Scores range from 1 to 10, with higher scores indicating better
adherence.
2.7.5 | Final assessment form
This form was part of the posttest material and was prepared by the
researcher according to previous literature.5,13 The form consists of
two questions examining voluntary discontinuation of medication
and belief in the necessity of medication.
2.8 | Ethical considerations
To implement the study, ethical approval was received from the
Clinical Trials Ethical Committee of Medical Faculty (70904504/
2015), institutional permission was granted by the hospital admin-
istration (26708535‐900/2021), and permission to utilize TIPS and
the scales was obtained from their owners. After the necessary
permissions were received, written consent was obtained from all
participants before the study began.
2.9 | Validity, reliability, and rigor
The TIPS Manual was translated into Turkish by three people who
speak Turkish and English very well in an academic context;
therefore, the manual could be evaluated in terms of language and
content compliance. The researcher developed a MAT protocol and a
MAT manual to conduct MAT systematically. Then, all of the tools
used in the intervention were evaluated by three academics who
specialize in psychiatric nursing. Following the preliminary applica-
tion, the entire content of the manual was finalized, and the TIPS
program was started.
2.10 | Data analysis
All analyses were performed using IBM SPSS 20.0 (IBM
Corporation, Armonk, NY) with statistical significance set at
P < 0.05. The Shapiro‐Wilks test was used to assess normality. To
determine the homogeneity of the intervention and control
groups after randomization, the Mann‐Whitney U test, which is
a nonparametric test, was used in the analysis of constant
variables, and Fisher's exact test or the Pearson χ2 test was used
in the analysis of categorical variables. Statistics were presented
as the frequency, percentage, median, and minimum (min)
and maximum (max) values. The reliability of the scales was
evaluated by examining the Cronbach α and Kuder‐Richardson 20
coefficients. While the medication adherence pretest‐posttest scores for the intervention and control groups were compared
using the Wilcoxon signed‐rank test, the scores for belief in
the necessity of medication and voluntary discontinuation of
medication were compared using the McNemar test. Medication
adherence scores for the intervention and control groups
before and after the intervention were compared using the
Mann‐Whitney U test.
3 | RESULTS
A total of 46 people participated in the study, 58.7% were women
and 67.4% were single. The participants had an age average
of 38.9 years and had been diagnosed with schizophrenia for
10 years on average. In addition, 58.7% of the participants described
their economic condition as “medium,” and several of them (4.3%)
stated that they lived alone and had no one to support them.
3.1 | Findings concerning drug use characteristics
Drug use characteristics were evaluated with the criteria for
discontinuing medication willingly and belief in the necessity of
USLU AND BULDUKOGLU | 67
medication (Table 3). The rates of voluntary medication discontinua-
tion among the participants in the intervention and control groups
after TIPS were compared within groups. The rates of continued
medication use among the individuals in the intervention and control
groups were significantly increased (P < 0.001). In comparisons
between the groups, however, the rate of continued medication
use after TIPS was significantly higher in the intervention group than
that in the control group (P < 0.001).
The rate of believing in the necessity of medication after TIPS
was compared within groups. While the rate remained the same in
the control group (P = 0.999), it was significantly increased in the
intervention group (P = 0.008). In comparisons between the groups,
however, the rate of believing in the necessity of medication after
TIPS was significantly higher in the intervention group than that in
the control group (P = 0.004).
3.2 | Findings concerning medication adherence
Medication adherence was evaluated with MARS scores (Table 4).
MARS scores were compared within groups after TIPS. A statistically
significant decrease in MARS scores was observed for the partici-
pants in the control group (P = 0.001), whereas a statistically
significant increase was observed in the intervention group
(P < 0.001). In comparisons between the groups after TIPS, however,
the MARS scores of the intervention group were statistically higher
than those of the control group (P < 0.001).
4 | DISCUSSION
To increase the medication adherence of patients with schizophrenia,
individual‐specific interventions that have been demonstrated to be
effective by many experimental studies are needed.17,36 Accordingly,
TIPS is considered a cost‐effective option that encourages patients
with schizophrenia to participate in their own treatment and
supports individual‐specific care.22 In this study, the effect of TIPS
on medication adherence in patients with schizophrenia was
examined. Our findings supported all the hypotheses. Accordingly,
the patients with schizophrenia who participated in TIPS had lower
rates of discontinuing medication willingly compared to the patients
who did not participate in TIPS. Additionally, the rates of believing in
the necessity of medication and medication adherence were higher
after TIPS participation compared with those among the patients
who did not participate in TIPS.
For a patient to maximally utilize medication and to decrease
relapse, psychiatric nurses should pioneer new methods to increase
TABLE 3 Comparison of drug use characteristics between groups and within groups (n = 45)
Drug use characteristics Before TIPS, n (%) After TIPS, n (%) Within group (P) Between group (P)
Voluntary discontinuation of medicine Control group (n = 24)
Yes 24 (100) 12 (50) <0.001a <0.001b
No 0 (0) 12 (50) Intervention group (n = 21)
Yes 21 (100) 0 (0) <0.001a
No 0 (0) 21 (100)
Belief in the necessity of medication Control group (n = 24)
Yes 16 (66.7) 16 (66.7) =0.999a =0.004c
No 8 (33.3) 8 (33.3) Intervention group (n = 21)
Yes 13 (61.9) 21 (100) =0.008a
No 8 (38.1) 0 (0)
Abbreviation: TIPS, Telephone Intervention Problem Solving. aMcNemar's test. bPearson's Ki‐kare test. cFisher's exact test.
TABLE 4 Comparison of Medication Adherence Rating Scale scores between groups and within groups (n = 45)
Within group Between group
MARS score Median Min‐Max Z P U P
Control group (n = 24) Before TIPS 5 1‐8 −3.237a =0.001 4.5b <0.001 After TIPS 4 0‐7
Intervention group (n = 21) Before TIPS 4 3‐6 −4.039a <0.001 After TIPS 9 6‐10
Abbreviations: MARS, Medication Adherence Rating Scale; max, maximum; min, minimum; TIPS, Telephone Intervention Problem Solving. aWilcoxon's signed‐rank test. bMann‐Whitney's U test.
68 | USLU AND BULDUKOGLU
medication adherence.37 In this context, evaluating whether patients
with schizophrenia face any problems with their medication and their
attitudes toward medication is useful.5 In other words, a patient's
self‐report is important for evaluating medication adherence.11
Considering this information, this study used a self‐reported outcome
measure. Thus, the utilization of scales and patient self‐reports is a
strong aspect of the study.
Determination of medication adherence is among the top care
goals of psychiatric nurses.38 However, nurses are frequently trained
as clinical nurses, resulting in limitations related to transferring from
direct care to telemedicine interventions.39 In one study, nurses
indicated that they were frustrated and stressed because of patients'
absence during the implementation of telenursing. They also had
doubts regarding whether telenursing was “real nursing.” In addition,
they stated that they had some concerns about patients' access to
service and service delivery by nurses via this approach.40 Further-
more, relevant limitations exist in Turkey.41 Considering these data,
this study can help close the gap between clinical findings and
scientific evidence from three perspectives. The study offers (i) a care
option with a higher degree of evidence from experimental testing,
(ii) a standardized care option that can be used for guidance, and (iii)
guidance on how to transfer telecommunication tools to psychiatric
nursing interventions.
Voluntary discontinuation of medication and belief in the necessity
of medication among patients with schizophrenia are closely related to
medication adherence.5,12,13,17 Thus, this study examined these two
factors among patients. At the beginning of the study, all of the patients
discontinued their medication willingly (Table 3). Considering the
negative results for medication adherence problems,9 this finding
reveals the seriousness of such problems and the necessity of this study.
This study showed significant positive effects on voluntary discontinua-
tion of medication and belief in the necessity of medication in the TIPS
intervention group (Table 3). Because no other study has examined the
effect of TIPS in this patient population,25 these data represent a novel
addition to the existing literature.
According to the findings of the study, TIPS significantly increases
medication adherence in patients with schizophrenia (Table 4). These
findings also coincide with the results of studies with similar study
design.11,27,29 However, while the MARS scores of the intervention
group increased, the MARS scores of the control group decreased
(Table 4). This finding shows that MAT, which was provided to both
groups at the beginning of the study, is not only effective for
increasing medication adherence and also confirms the necessity of
TIPS. In addition, psychoeducation, which is one of the basic
interventions of psychiatric nursing,37 is not effective for medication
adherence, which should be considered.
4.1 | Limitations and recommendations for future studies
This study has several limitations. As the study was implemented within
the scope of a doctoral thesis, the interview and intervention were
conducted by the same researcher, which did not allow the researcher
to be blinded. Thus, the first limitation is that no blinding was performed
when the participants were assigned to groups. Blinding is recom-
mended for future studies. The second limitation is that the study had a
pretest‐posttest design and only a 2‐month follow‐up. To test the long‐ term effectiveness of TIPS, researchers should plan to follow patients at
certain intervals after the intervention is completed. The final limitation
is that only one center was included in the study. To generalize the
results to the population of Turkey, different populations should be
used in future experimental studies.
5 | CONCLUSIONS AND PRACTICE IMPLICATIONS
In this study, TIPS was used in the care of patients with schizophrenia
for the first time in Turkey. This study was also the first to examine
the effects of TIPS on the states of patients with schizophrenia who
discontinue medication willingly and their belief about the necessity
of medication. According to the results of this randomized controlled
study, TIPS is a telenursing application that can prevent patients with
schizophrenia from discontinuing medication willingly and increase
their belief in the necessity of medication and medication adherence.
According to these findings, (i) nurses who are the decision‐makers in
clinics should be informed of the advantages of TIPS and should
consider implementing TIPS in their clinics, (ii) clinical nurses should
be included in related studies and informed of the utilization of TIPS,
(iii) experimental studies should be implemented to evaluate the
effects of TIPS on various difficulties faced by patients with
schizophrenia, and (iv) policy‐makers should support the develop-
ment of mobile health practices.
ACKNOWLEDGMENTS
The researchers would like to thank Prof. Dr. Lora Humphrey Beebe
who provided full support in planning the study and shared their
knowledge unconditionally, nurses of the psychiatry clinic who
contributed to the implementation of the study, patients with
schizophrenia who accepted to participate in the study for the
progress of the science of nursing and Dr. Başak Oğuz Yolcular who
conducted the statistical evaluation of the data.
CONFLICT OF INTERESTS
The authors declare that there are no conflict of interests.
ORCID
Esra Uslu http://orcid.org/0000-0003-0168-2747
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How to cite this article: Uslu E, Buldukoglu K. Randomized
controlled trial of the effects of nursing care based on a
telephone intervention for medication adherence in
schizophrenia. Perspect Psychiatr Care. 2020;56:63‐71. https://doi.org/10.1111/ppc.12376
USLU AND BULDUKOGLU | 71
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