Spirituality, Self-Care, and Social Activity in the Primary Medical Care of Elderly Patients

Results of a Cluster-Randomized Interventional Trial (HoPES3)

Background: Self-efficacy is decisive for the quality of life of elderly, multimorbid persons. It may be possible to strengthen patients’ self-efficacy can be strengthened by the targeted reinforcement of individual spirituality, social activity, and self-care. This hypothesis was tested with the aid of a complex intervention.

Methods: A non-blinded, exploratory, cluster-randomized, controlled trial was carried out, with primary care practices as the randomization unit (registration number DRKS00015696). The patients included were at least 70 years of age, had at least three chronic diseases, were taking at least three medications, and were participating in a disease management program. In the intervention group, primary care physicians took a spiritual history, and medical assistants advised the patients on the use of home remedies (e.g., tea, application of heat/cold) and on regionally available programs for the elderly. The primary endpoint—health-related self-efficacy, measured using the SES6G scale—and further, secondary endpoints were evaluated with multistep regression analyses.

Results: Data from 297 patients treated in 24 primary care practices were evaluated. The analysis of the primary endpoint indicated no effect (mean difference between study arms 0.30 points, 95% confidence interval [−0.21; 0.81], d = 0.14, p = 0.25). Subgroup analysis revealed the following situation for the secondary endpoint “mental well-being” (SF-12 subscale): patients who had already been using home remedies before the trial began experienced a marked improvement (a difference of 7.3 points on a scale from 0 to 100; d = 0.77, p < 0.001). This was also the case for patients who stated that spirituality played a major role in their lives (a difference of 6.2 points on a scale from 0 to 100; d = 0.65; p = 0.002).

Conclusion: The main hypothesis concerning health-related self-efficacy was not confirmed. The results of the analysis of secondary parameters indicate that some subgroups of patients can benefit from the interventional approach.

About one third of the European population suffer from chronic conditions requiring treatment with multiple medications (1). Disease Management Programs (DMP) offer chronically ill patients structured assessments every 3–6 months (2). While DMP are mainly intended to standardize diagnostic procedures and treatment, the integration of holistic aspects of healthcare, such as spirituality, social activity, and self-care, could strengthen patients’ self-efficacy and thus contribute to more patient empowerment.

Self-efficacy, i.e., the subjectively perceived ability to achieve self-defined goals, has been demonstrated to be a decisive factor for elderly patients’ quality of life (3).

Spirituality has been linked to self-efficacy (4). The definitions of spirituality and spiritual needs are heterogeneous but often have four attributes in common (5, 6):

• Connectedness (e.g., feeling connected to family)
• Transcendence (e.g., immersion in nature, praying)
• Peace (e.g., finding inner peace, relaxing in a peaceful place)
• Meaning in life (e.g., passing on life experience, being sure that one’s own life is meaningful)

In the context of this study, we defined spirituality as anything that lends meaning to a person’s life and serves as a personal resource. This definition was also chosen to emphasize that spirituality encompasses more than religion.

Self-care, defined in this study as activities—aside from taking medication—that patients can accomplish on their own to increase their personal well-being, and social activity are reciprocally related to self-efficacy (7, 8, 9) and spirituality (4, 10).

The overall aim of the “Holistic Care Program for Elderly Patients to Integrate Spiritual Needs, Social Activity and Self-Care into Disease Management in Primary Care (HoPES3)” was to strengthen these aspects in primary care. It was assumed that interventions designed to increase patients’ awareness of their personal and spiritual resources and encourage social activities and self-care would strengthen self-efficacy and in the long run improve the quality of life. Self-efficacy was therefore defined as the primary outcome. The rationale for these assumptions is described in detail in the study protocol which also contains a theoretical model of the assumed effect mechanisms of the intervention (11).

The objective of this study was to assess the effectiveness of the HoPES3 intervention at the patient level in terms of primary and secondary outcomes.

Methods

Trial design

Between March 2019 and June 2020, a cluster-randomized controlled trial was conducted with primary care physicians’ offices as unit of randomization and follow-up of 6 months. Owing to the lack of previous experience regarding possible intervention effects, the study was conceived as an exploratory pilot study. The study was reviewed by the responsible ethics committees of the University Hospital Heidelberg and the Baden-Württemberg Medical Association, registered with the German Clinical Trials Register (DRKS 00015696), and funded by the Federal Ministry of Education and Research (funding code 01GL1803).

Recruitment

All general practices in defined regions of southern Baden-Württemberg were contacted by post. Primary care physicians (PCP) who offered at least one DMP and the medical assistants of these PCP were eligible (a task description of medical assistants in Germany can be found in [12]). The participating PCP informed all patients who met the inclusion criteria and were scheduled for DMP appointments within the next 3 months about the study. The inclusion criteria were as follows:

• Age ≥ 70 years
• At least three chronic conditions
• Taking at least three medications
• Participating in at least one DMP
• Capable of active participation in the study

Moreover, the PCP were requested predominantly to include patients who, in their estimation, would benefit from the intervention.

Data collection

The data on measurement of outcomes were collected using questionnaires that were completed at the time of enrolment (T0) and 6 months after the intervention (T1). Furthermore, at T0, the medication plans were acquired from the office’s administration system.

Interventions

While in the control group the DMP was conducted as before, patients in the intervention group additionally received the HoPES3 intervention, which focused on three domains:

• Spiritual needs
• Self-care by means of home remedies
• Social activity and loneliness

A spiritual history was taken by the PCP according to the conversational model SPIR: The four key questions (Box and eSupplement 1), which can be supplemented or replaced by subquestions in order to adapt the language to the individual patient, allow structured acquisition of important information about the patients’ spirituality, including their desire for more social contacts and self-care measures (13).

Box

Key questions of the conversational model SPIR with exemplary sub-questions

Next, the medical assistants provided information about regional social activities for seniors and/or home remedies, i.e. non-pharmacological interventions that patients can accomplish on their own to relieve symptoms that frequently occur in old age (e.g., heat/cold treatments and herbal applications). For this purpose, PCP offices and patients received information leaflets on home remedies (eSupplement 2) and a web-based list of social activities for seniors within a radius of 10 km of the respective office. All materials had been elaborated by the study team and were available via the study’s website (www.hopes3.de). Patients were asked to document their spiritual, social, and self-care activities in a standardized diary. The PCP and medical assistants were trained by the study team in a 4-hour workshop. A more detailed description of the intervention can be found in other publications (11, 14).

Outcomes and instruments

Health-related self-efficacy was defined as primary outcome and measured on the Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G) (15). In accordance with to the exploratory character of the trial, a range of secondary patient outcomes (n = 8) were measured with validated questionnaires (Table 2, eTable 1). Additionally, non-validated items were used to assess patients’ awareness of their sources of strength (two items) and the use of home remedies (one item) (eTable 1).

Table 1

ITT analysis for primary and secondary outcomes

Table 2

Baseline characteristics of the study participants

eTable 1

Intention-to-treat (ITT) analysis for primary and secondary endpoints (supplementing Table 1)

Statistical methods

The primary efficacy analysis was carried out via a mixed linear model, with the SES6G score at T1 as a dependent variable as well as the fixed factors treatment group, gender, SES6G score at T0, age, and number of drugs and the random factor PCP office. The primary analysis was conducted according to the intention to treat (ITT) principle. Secondary endpoints were evaluated analogously to the primary endpoint. A detailed description of the statistical methods can be found in the eMethods.

Results

Inclusion and exclusion of participants

The Figure shows the study participants’ inclusion and exclusion. Data from 24 PCP offices (13 intervention group, 11 control group) and 297 patients (164 intervention group, 133 control group) were analyzed.

Figure

Flow chart showing inclusion and exclusion of study participants

Recruitment

The PCP offices were recruited between March and May 2019. Baseline assessments were completed within 4 weeks prior to the workshops for office teams (on 29 June 2019 and 3 July 2019) which marked the beginning of the intervention phase. Since the targeted patient sample size had not been reached, enrolment continued till September 2019. Therefore, allocation concealment could not be maintained for patients recruited after the workshop (n = 73, 24.6%). Six months after the HoPES3 intervention, between December 2019 and June 2020, patients completed the questionnaires for follow-up assessment.

Baseline data

Table 2 shows the sociodemographic characteristics of the participants. The baseline characteristics of the two groups were broadly comparable.

Primary and secondary outcomes

Intention-to-treat analysis

As shown in Table 1, the intention-to-treat analysis, which included all 297 patients from 24 offices, detected no effect on the primary outcome (health-related self-efficacy measured on the SES6G scale). The intracluster correlation coefficient for the primary outcome was 0.0479, indicating a small but not inconsiderable degree of similarity among the patients from a given office with regard to health-related self-efficacy.

Among the 11 secondary endpoints, a marginal effect of the HoPES3 intervention could be observed on mental well-being as measured by a subscale of the SF12 questionnaire (17). The difference of 3.34 points on a scale of 0–100 corresponds to a weak effect (d = 0.35, p = 0.006). The data for the remaining secondary outcomes can be found in eTable 1.

Per-protocol and subgroup analyses

eTable 2 shows the detailed results of the subgroup analyses. Interesting observations were made especially with regard to mental well-being:

Patients who stated that they had already used home remedies before the trial (n = 71) showed a notable improvement (7.34 points difference). This almost corresponds to a strong effect (d = 0.77, p<0.001). The same was the case for patients who stated that spirituality mattered a lot in their lives (n = 69). Here, the SF12 subscale improved by 6.2 points which indicates a moderate effect (d = 0.65, p = 0.002).

eTable 2

Per-protocol and subgroup analyses

Patients with a large social network (n = 157) showed a stronger improvement regarding mental well-being (4.83-point difference indicating a moderate effect, d = 0.50, p = 0.003) than patients with a small social network (−0.58-point difference indicating no effect). Similarly, patients who did not feel lonely (n = 175) showed more improvement (3.78-point difference indicating a weak effect, d = 0.39, p = 0.003) than lonely patients (−1.11-point difference indicating no effect).

Further, weak effects were found in patients not taking any psychotropic drugs (3.78-point difference, d = 0.39, p = 0.003), but no effects could be detected in those with psychotropic drugs prescribed (n = 22).

Another interesting observation concerned the comparison between the predefined patient populations (eMethods): considering all patients, effects on mental well-being tended to be stronger if patients had participated in both spiritual history taking and advice on home remedies and/or social activities (EST 3.36 versus 4.17). This was also the case for the subgroup of home remedy users (EST 7.15 versus 7.73).

Harmful effects

Patients were asked to complete a questionnaire within 2 weeks after the HoPES3 intervention. Only 2.5% (n = 3) of the patients stated that the conversation had been (very) stressful for them.

Discussion

This study evaluated the effectiveness of a complex intervention to strengthen self-efficacy and thereby improve elderly multimorbid patients’ quality of life. While no relevant effect on the primary outcome was detected, the analyses of the secondary outcomes and the subgroup analyses led to some interesting observations concerning mental well-being:

Strong effects on mental well-being were found in patients who had already used home remedies prior to study participation. This is in line with the findings of Puig Llobet et al., who observed a positive association between self-care ability and mental health (18). An explanation could be that—independent of possible specific therapeutic effects of the home remedies—patients felt empowered to have confidence in their own coping strategies. It is possible that the patients perceived the proactive recommendations on home remedies and the office teams’ deep interest in their personal sources of strength as an expression of respect and assurance towards their pre-existing self-care abilities.

The complex intervention led to a notable improvement on the mental well-being scale in patients who had stated that spiritual or religious beliefs greatly mattered in their lives. A positive correlation between spiritual/religious coping and mental well-being has been described in previous studies (4). The accompanying process evaluation (19, 20) showed that spiritual patients were more open to the spiritual history taking, while less spiritual patients were more reluctant—mainly because they associated spirituality with church or religion in a negative way. This may explain the lack of effects in this patient group.

No improvement of mental well-being was noted in the subgroup of psychotropic drug users. Possible explanations could be that those patients were seriously ill and therefore required a more intensive intervention, or that they were less open to non-pharmacological alternatives.

Similarly, no effects on mental well-being were found in lonely patients or in patients with a small social network. This observation may be due to the low proportion of less than 10% of lonely, isolated patients in the study population, so that the statistical power was not sufficient to detect weaker effects. This suggests that more active, well integrated patients took part in the study, as also shown by the process evaluation (20). Moreover, the COVID-19 pandemic restricted social activities. Another explanation is that the strategies used to increase social contacts were not sufficient to activate lonely, isolated patients. Achieving that would probably require a more intensive case management program, including home visits and educational measures targeting behavioral change (21). In addition, other studies indicate that spiritual/religious coping correlates positively with mental well-being only if social support and self-efficacy are present (4).

Interestingly, the effects tended to be stronger in patients whose PCP had taken a spiritual history and who had received information about home remedies and/or social activities, provided mainly by the medical assistants. This finding supports our experiences from previous studies with regard to the involvement of medical assistants in the care of chronically ill patients. Patients frequently approach medical assistants with questions they could not bring themselves to ask their PCP (22). Programs to improve the care of chronically ill patients should take advantage of this potential.

Limitations

The main limitation of the study is the limited representativeness of the samples. It is likely that mainly PCP with a special interest in complementary and holistic medicine participated in the study. Moreover, it is likely that selection bias occurred in favor of active, committed patients. Furthermore, the exploratory character of the trial does not permit any confirmatory conclusions regarding the effectiveness of the complex intervention.

Conclusion

The primary hypothesis of the trial concerning patients’ health-related self-efficacy could not be confirmed. Nevertheless, some interesting observations suggest that a proactive conversation about patients’ spirituality combined with proactive information on home remedies and regional social activities could usefully complement the DMP for certain patient groups. Medical assistants may have an important role in delivering these interventions.

It seems that patients with stronger spiritual convictions and a preference towards non-pharmacological treatment options such as home remedies may benefit from low-threshold interventions. In contrast, patients who are less active, less integrated, and less aware of their personal and spiritual resources may need a more intensive intervention or a different style of intervention.

The strongest effects in these subgroups were observed on mental well-being. This finding may be of interest regarding the new DMP for depression, which was developed after the beginning of this trial. Although no recommendations for daily practice can be derived, our results provide valuable information for future confirmatory trials.

Conflict of interest statement
The authors declare that no conflict of interest exists.

Manuscript submitted on 27 July 2021, revised version accepted on 2 December 2021

Corresponding author
Dr. med. Cornelia Straßner
Universitatsklinikum Heidelberg
Allgemeinmedizin und Versorgungsforschung
Im Neuenheimer Feld 130.3, 69120 Heidelberg, Germany

Cite this as:
Sturm N, Krisam J, Szecsenyi J, Bentner M, Frick E, Mächler R, Schalhorn F, Stolz R, Valentini J, Joos S, Straßner C: Spirituality, self-care, and social activity in the primary medical care of elderly patients—results of a cluster-randomized interventional trial (HoPES3). Dtsch Arztebl Int 2022; 119: 124–31. DOI: 10.3238/arztebl.m2022.0078

►Supplementary material

eMethods, eTables, eSupplements:
www.aerzteblatt-international.de/m2022.0078

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