Patient sample and data
Data were retrieved from the prospective controlled randomized intervention trial Tecla. Inclusion criteria of Tecla were a medical diagnosis of any form of schizophrenia (ICD-10 F20), schizoaffective disorders (ICD-10 F25), or bipolar disorders (ICD-10 F31), and age ≥ 18 years. The diagnoses were extracted from the patient files. Exclusion criteria were prior scheduled inpatient treatments within the next six months and lacking reachability by cell phone. The participants were recruited shortly before their discharge from day-care hospitals or open or locked inpatient wards from three psychiatric departments in Western-Pomerania, a Federal State in the very northeast of Germany.
Tecla has been approved by the Ethics Committee of the University Medicine Greifswald (BB 122/14) and was registered at the German Clinical Trials Register (date 2015\05\21, DRKS00008548). A comprehensive description of the study protocol for the Tecla study was published by Stentzel et al. [14].
Randomization
The participants were randomized to the intervention or control group after the baseline assessment. A blinded scientist, who was neither involved in the recruitment nor in the baseline assessment, performed the allocation to the groups using a random allocation (block randomization). The listing of the two groups was unregularly. The participants were chronically signed to the next entry in the randomization list.
Telemedical intervention
Participants were individually randomized to intervention group and control group. Both groups received care as usual in the outpatients facilities (outpatient psychiatric / psychotherapeutic practices or psychiatric institutional outpatients' departments). The intervention group received regular telephone calls every two weeks and in addition standardized as well as individualized text messages every week. An example for such an individualized text message is given in Figure 1. Qualified nurses who are specialized in telemedical care conducted the regular telephone calls. The nurses are embedded in regular meetings within one of the psychiatric institutional outpatients' department and day-care hospital. They were trained in the documentation system and join appropriate psychiatric/psychotherapeutic education programs. The telemedical conversation was conducted on the basis of eCRFs in a computer-aided documentation system in accordance with the current standards for data security and data privacy [15, 16]. The standardized conversation contained a structured standardized and an individualized part. The structured standardized part of the telephone calls included suicidal tendencies, changes in the medication regime, medication adherence and medication side effects (study protocol published elsewhere [13]). The individualized part addressed selected topics of everyday life that the respective participant evaluated as important for himself and his condition. The weekly text messages refer to actual and relevant events and themes in the daily life of the participants.
Measures
WHOQOL-BREF
The quality of life was measured with WHOQOL-BREF, the short version of the subjective instrument World Health Organization Quality of Life, which is designed for generic use [9, 17]. It assesses the quality of life from a subjective perspective [7]. The short version WHOQOL-BREF has 26 items. Answers are given on 1-to-5-point Likert scales. Summing all 26 items gives total quality of life, ranging from 26 to 130 [18]. The higher the score the better the quality of life of the patient [17]. WHOQOL assesses different aspects of life that are relevant for quality of life [9]. The WHOQOL-BREF bases on four domains [9, 17] and one global value for general quality of life:
- Physical domain: pain, energy, sleep, mobility, activities, medication, work.
- Psychological domain: positive feelings, cognitions, self-esteem, body image, negative feelings, spirituality.
- Social relationships domain: personal relationships, social support, sex.
- Environment domain: safety and security, home environment, finance, health/social care, information, leisure, physical environment, transport.
- Global value: overall quality of life, general health.
The German version was used, which shows good internal consistence (Cronbachs α > 0.7 for all domains) for the overall population as well as for patients with mental disorders [19].
Social support
Social support was assessed using the measure F-SozU (Social support, short form with 14 items) [20]. The authors defined social support as the result of cognitive-emotional processing and assessment of current and past social interactions. The concept is based on cognitive approaches and assesses the subjective conviction to get support from the subject’s social network if necessary. This 14-item short form is appropriate for the assessment of a more generally perceived social support [20]. The statements refer to the fields of emotional support (to be liked and accepted by others, to share feelings, to experience participation), to provide practical assistance (practical help in everyday problems, for example to borrow things, getting practical advice, getting help with challenging tasks) and social integration (belonging to a circle of friends, doing joint ventures, knowing people with similar interests) and are assessed using a 5 category Likert-scale from “does not apply” (scored 1) to “applies exactly” (scored 5) [20, 21].
Global assessment of functioning (GAF)
The Global Assessment of Functioning (GAF) is an overall measure of how patients are doing from positive mental health up to severe psychopathology [22]. It is known, that functioning is low in people with current mental health disorders, so functioning can be used as an expression of the severity of illness [23]. The GAF-questionnaire measures the degree of mental illness by rating psychological, social and occupational functioning [22] on an ordinal scale from 1 to 100 [24]. The scale is divided into 10-point intervals. The lowest interval (score 1 to 10) represents severe illness, the highest interval (score 91 to 100) represents the healthiest condition [21, 22].
Participants’ evaluation of the telemedical care program
Participants of the intervention group were asked to evaluate the telemedical care at the end of their study participation by answering the questions shown in Table 1.
Table 1: Interview questions and answers to assess acceptance and satisfaction of the participants
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Question:
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How would you assess the telephone and text messages contacts during the last 6 months?
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Answer:
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Very helpful – little helpful – not helpful – other (free text) – don’t know – no answer
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Question:
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Could you imagine continuing the telephone contacts in this form?
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Answer:
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Yes – No – don’t know – no answer
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Question:
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Do you think this kind of care can partly replace personal contacts with physicians or psychologists?
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Answer:
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Yes – No – don’t know – no answer
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Question:
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Is there something you would change or improve?
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Answer:
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Yes – No – don’t know – no answer and additional free text
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Statistical analysis
The baseline characteristics were compared by group affiliation to identify any group differences at baseline. A linear mixed model regression was calculated to test for the intervention effects. The computation was performed using SAS PROC MIXED (SAS 9.4 © 2002-2012 by SAS Institute Inc., Cary, North Carolina, USA.). For parameter estimation, a minimum variance quadratic unbiased estimation (MIVQUE0) was performed, using unstructured covariance matrices. The WHOQOL total quality of life as well as each of the WHOQOL domains and the global value were the respective dependent variable. As fixed effects served the affiliation to the patient group, age, gender, education, social support, and the Global Assessment of Functioning (GAF). The subjects served as random effect. In order to control for the time of assessment (baseline and 6-month-follow-up), a repeated statement was included in the model. Results are considered statistically significant when P-values are 0.05.
The analyses were conducted with the intention-to-treat approach. For randomized clinical trials with missing data the multiple imputation procedure is a valid method to handle missing data [25] and to minimize possible biases [26]. However, a required condition for multiple imputation is, that missing data are distributed completely at random (MCAR) or at random (MAR), whereas the method is less appropriate for data missing not at random (MNAR) [27]. After thorough inspection, we appraised the missing data as MAR. The proportions of missing values ranged from 11 – 17 % (WHOQOL-variables 12 %). Hence multiple imputation was proceeded. To be able to reproduce the results, each time the analysis is performed the random seed value was specified [25]. Eighteen variables were included in the imputation model. Minimum and maximum values for score values were defined. Further details are documented in the supplement. All statistical procedures were performed in SAS 9.4 (© 2002-2012 by SAS Institute Inc., Cary, North Carolina, USA.).